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PROSTATE CANCERA GUIDE FOR PATIENTS AND THEIR FAMILIES

Fox Chase Cancer Center Page 1

Prostate Cancer: A Guide for Patients and Their Families

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If you are worried about your

prostate cancer risk, or you or a

loved one has been diagnosed with

prostate cancer, having accurate

information about the disease and

its treatment can help you make

the best healthcare decisions.

Fox Chase Cancer Center’s prostate

cancer team has put together this

guide to help you understand

prostate cancer and the range of

treatment options available.

INSIDE THIS GUIDE

What Is Prostate Cancer? . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Symptoms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Risk Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Diagnosing Prostate Cancer . . . . . . . . . . . . . . . . . . . . . . . . 3

Staging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Assessing Risk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Treatment Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Observation: Active Surveillance or Watchful Waiting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Localized Therapies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Surgery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Radiation Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Ablation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11

Focal Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11

Systemic Therapies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Hormone Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Chemotherapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Immunotherapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Other Drug Therapies for Advanced Prostate Cancer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Alpha Emitter Radiation Therapy (Alpharadin, Brand Name Xofigo®) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Enzalutamide (Xtandi®) and Abiraterone (Zytiga®) . . . . . . . . . 14

Clinical Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Prostate Cancer Risk Assessment . . . . . . . . . . . . . . 16

Why Choose Fox Chase? . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

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WHAT IS PROSTATE CANCER?Prostate cancer is a disease in which some of the cells of the prostate gland grow and divide in an uncontrolled way. The resulting mass is called a malignant tumor, which often originates in the outer part of the prostate. This guide will focus on the most common type, called prostatic adenocarcinoma. There are a few other types of prostate cancer, but they are extremely rare. Other than skin cancer, prostate cancer is the most common cancer in men—nearly 200,000 cases are diagnosed in the United States each year. Fortunately, most prostate cancer is discovered when it is still confined to the prostate gland and does not show evidence of having spread (or metastasized) from its original location. Prostate cancer is often very treatable, and men diagnosed with prostate cancer do not usually die from it. This type of cancer is more dangerous in its advanced stages, when it may become aggressive and spread to other organs. However, in general, prostate tumors tend to grow slowly, and some men who have prostate cancer may never be affected by it.

Sometimes the prostate can grow very large even if it is not cancerous. This is known as benign prostatic hyperplasia, or BPH. BPH is a separate common condition that may occur with or without prostate cancer and tends to become more frequent (and lead to an increase in urinary symptoms) as men age.

Symptoms

Men whose cancer is confined to the prostate rarely have any symptoms. Those with more advanced cancer can have pelvic pain, pain in the bones, blood in their urine (hematuria), bladder obstruction (causing urinary problems or impacting their kidney function), and other more general signs of illness, such as weight loss, fatigue, weakness, and decreased appetite.

Risk Factors

Age, race/ethnicity, and family history all affect someone’s chance of developing prostate cancer. The disease is very rare in men younger than age 40, but the risk rises rapidly after age 50. Most prostate cancers are diagnosed in men older than age 65, and most deaths from prostate cancer occur in men older than age 75. Compared to Caucasian men, prostate cancer occurs more often in African American men and Caribbean men of African descent and less often in Asian American and Hispanic/Latino men. A family history of prostate cancer also increases someone’s chances of developing the disease, and having a father or brother with prostate cancer more than doubles the risk.

A number of other factors—both genetic and environ-mental—appear to influence the risk of prostate cancer as well. At Fox Chase, our team of physicians and scientists continues to investigate the relationship between these risk factors and the actual development of prostate cancer.

Where is the Prostate?

The prostate gland, which is part of the male reproductive system, secretes fluid that contributes to semen. The prostate is located in front of the rectum and below the bladder, and while it is usually the size of a walnut, it can grow much larger. The prostate gland starts to develop before birth and then grows rapidly during puberty.

The prostate surrounds the urethra (the tube that carries urine out from the bladder), and when the prostate is enlarged, it can constrict the normal flow of urine and result in urination problems. The urethra also carries semen from the seminal vesicles (two small reservoirs that supply most of the seminal fluid) during ejaculation, and the duct leading from the seminal vesicles to the urethra passes through the prostate. Courtesy: National Cancer Institute





DIAGNOSING PROSTATE CANCERScreening for prostate cancer may involve a digital rectal exam as part of a regular medical checkup. In this quick test, the doctor inserts a gloved finger (a “digit”) into the rectum to check the size of the prostate and determine whether any parts of it are lumpy or unusually hard. The doctor may also recommend a blood test to check levels of a protein called prostate specific antigen (PSA), which is produced by the prostate gland. The PSA blood test is a helpful but imperfect indicator of prostate cancer risk (see the box on page 4 for more details).In the past, if initial screening results were abnormal and suggested that a further assessment was warranted, the most common next step was prostate biopsy. However, with the introduction of specialized prostate imaging (MRI or micro-ultrasound), more patients are now being offered prostate imaging before a prostate biopsy. Prostate imaging done with MRI or micro-ultrasound allows the treating physician to assess concerning prostate lesions to target during a biopsy. And, for up to 30% of patients, these imaging methods may allow them to avoid a prostate biopsy altogether if the imaging is negative. If a prostate biopsy is required, the procedure involves removing very small samples of prostate tissue for microscopic analysis using a specialized needle device (guided by imaging technology). This is not a major procedure and can usually be done while the patient is awake by applying a local anesthetic to numb the biopsy area. The urologist typically takes 12 representative tissue samples (or “cores”) from different regions of the prostate, and the whole process takes about 10 minutes. It is normal to find some blood in the urine or stool in the week or so following the biopsy. Blood may also be seen in the semen for several weeks after the biopsy. While infections aren’t common, individuals will receive antibiotics before the procedure to reduce the odds of this happening.

There are multiple ways to diagnose prostate cancer and various biopsy options. Each patient’s individual situation will determine which method is most accurate and beneficial, and Fox Chase has experience with the latest technologies and techniques.

One such technology is the ExactVu™ micro-ultrasound, which merges the capabilities of MRI and a transrectal probe into a single device. During this outpatient test, a probe is placed in the rectum and allows the urologist to see the architecture of the prostate. This allows your care team to identify any concerning lesions and, if needed, take targeted biopsies. Micro-ultrasound provides a much higher image resolution than typical ultrasound technology used for identifying prostate lesions. This helps physicians perform more targeted and accurate biopsies as well as prevents unnecessary biopsies by allowing for a complete visual assessment of the patient’s prostate.

Fox Chase was also one of the first centers to use multiparametric MRI of the prostate to aid in the detection and monitoring of prostate cancer and has been at the forefront of MRI-ultrasound fusion targeted biopsy (where multiparametric MRI images are coupled with live prostate ultrasound images to optimize the results of the biopsy procedure). This state-of-the-art technology markedly improves biopsy accuracy and the identification of prostate tumors that wouldn’t be found through standard 12-core prostate biopsies. Fox Chase has extensive experience with this technique, is working to improve its effectiveness, and has faculty that regularly present research on the subject at academic meetings.

Fox Chase also offers transperineal biopsy as an alternative to traditional transrectal biopsy. Unlike a transrectal biopsy, where tissue samples are gathered through the rectum, transperineal biopsies gather tissue samples through two puncture sites in the perineum (the area between the anus and the scrotum). Compared to transrectal biopsies, this procedure offers a lower risk of post-procedure infection and procedure related bleeding.

Many prostate tumors grow so slowly that they will never cause problems. If this is the case, the person affected may prefer to keep their tumor under active surveillance rather than undergo further treatment at the time of diagnosis. MRI and fusion biopsy can help individuals and their doctors get a better idea about whether this active surveillance strategy makes sense for them.

Dr. Andres Correa and his colleagues on the urologic oncology team at Fox Chase have vast expertise with the latest technologies and techniques for prostate cancer diagnosis.





STAGINGProstate cancer is categorized into four different stages of development, each indicating tumor size and how far the disease has spread. The stages of prostate cancer are defined as follows:

• Clinical Stage T1 or T2: The disease is in its earliest stages and is clinically localized, meaning the cancer hasn’t spread beyond the prostate gland.

• Clinical Stage T3: The disease shows extracapsular extension, meaning the tumor has grown through the capsule surrounding the prostate and may have invaded the surrounding fat or seminal vesicles, which are adjacent to the prostate.

• Clinical Stage T4: The disease has invaded other local organs or spread to other parts of the body.

Cancers can spread to other organs in two ways: the tumor can grow into a neighboring organ, or more commonly, cancerous cells can get into the bloodstream or lymphatic system (both of which transport fluids throughout the body) and end up growing somewhere far from the original tumor site. Both processes are known as metastasis and these new cancer growths are called metastases (or metastatic tumors). Metastatic prostate cancer is still prostate cancer, even if it has spread to a distant area of the body. Regardless of where they are located, the cancer cells retain some degree of resemblance to prostate cells.

A prostate tumor’s stage can partly be determined by a digital rectal exam. If the tumor is large and/or irregular and the physician suspects it may have spread, radiographic imaging (such as a CT scan, MRI or bone scan) may help evaluate this possibility.

Fox Chase’s pathologists provide high quality and accurate diagnostic services to our patients.

UNDERSTANDING THE PSA TEST• The amount of prostate specific antigen (PSA) in

the blood tends to be higher in men with prostate cancer, which is why a PSA test is used for cancer screening. However, PSA level also depends on age, ethnicity, prostate size and other factors, so an elevated PSA level doesn’t always mean someone has cancer. In fact, two-thirds of the time, a high PSA level has nothing to do with cancer, and some prostate cancers don’t cause an increase in PSA at all.

• However, for men at high risk of developing prostate cancer, a PSA test can sometimes be useful when combined with other methods of cancer detection. For example, if an individual’s PSA levels are higher than usual and a digital rectal exam or MRI suggests that something is abnormal, their doctor is likely to recommend a biopsy.

• Individuals should weigh the potential benefits and downsides of PSA testing. To help minimize overdiagnosis and overtreatment while reducing the chances of undertreating aggressive prostate cancer, Fox Chase doctors are harnessing some of the latest tools (including new biological indicators, tissue genetic profiling, new imaging technology and novel biopsy techniques) to appropriately respond to this condition.





ASSESSING RISKPhysicians grade the aggressiveness of prostate cancer to determine the likelihood of significant risk to their patient’s life and health. This process, called risk stratification, can help individuals make vital decisions about their care. Prostate cancer is usually rated as low risk, intermediate risk, or high risk based on clinical stage, blood PSA levels, and information gained from a prostate biopsy. This assessment includes the cancer’s Gleason score (see the box on this page), the number of tissue samples in which cancerous cells were found and the percentage of each of the tissue cores affected by the tumor.

Prostate cancer risk is generally categorized as follows:

• Low Risk: Gleason score of 6 (Gleason Grade Group 1), a PSA level of less than 10 nanograms per milliliter (ng/ml) of blood, and a clinical stage of T2 or less

• Intermediate Risk: Gleason score of 7 (Gleason Grade Group 2 or 3), and/or a PSA level between 10 and 20 ng/ml, and a clinical stage of T2 or less

• High Risk: Gleason score of 8–10 (Gleason Grade Group 4 or 5), and/or a PSA level higher than 20 ng/ml, or a clinical stage of T3 or higher

ABOUT GLEASON SCORE AND GLEASON GRADE GROUPINGS The Gleason score is a grading system used by urologists to assess a prostate cancer’s aggressiveness.

Prostate cancers often have areas with different grades (numbers between 1 and 5 that rate how abnormal cells are). After a biopsy, a pathologist assigns grades to the two areas that make up most of the cancer, and these two grades are added to yield the Gleason score.

Grades 1 and 2 are not used to describe cancer; therefore, the lowest possible Gleason score of a cancer found in a prostate biopsy is 6 (3+3)—cancer with the least risk of spreading quickly. The highest score is 10—cancer with the most risk of being aggressive.

Because a scoring system that starts with the number 6 can be confusing, the Gleason grade grouping was recently introduced. This is based on the numbers used to create a cancer’s Gleason score and range from 1 (most favorable prognosis) to 5 (least favorable prognosis):

Grade Group 1: Gleason score of 6 (3+3=6) or less

Grade Group 2: Gleason score of 7 (3+4=7)



Grade Group 5: Gleason score of 9–10 (4+5=9, 5+4=9, 5+5=10)





TREATMENT OPTIONSWhen faced with a diagnosis of prostate cancer, remember that there are various treatment options depending on risk group, life expectancy, and the potential impact of both the disease and its treatment on quality of life. At Fox Chase, our physicians work closely with individuals to determine the best course of action based on their diagnosis and preferences.

For example, if an individual has low-risk cancer, is at an advanced age or has a number of other significant ongoing illnesses, they might choose to not actively treat the cancer when it is diagnosed. On the other hand, if their cancer is high risk, combining surgery, radiation, and/or systemic therapy may be the best option.

In general, treatment approaches to clinically localized (clinical stage T1 or T2) prostate cancer fall into three categories: observation, surgery, and radiation. No single treatment type fits every patient—instead, it’s a question of what will work best for each patient and their cancer. Note that individuals may need more than one type of treatment depending on how aggressive their cancer is. Individuals should always feel free to seek out an informed second opinion about their diagnosis or recommended course of treatment.

Observation: Active Surveillance or Watchful Waiting

Doctors may recommend forgoing or postponing therapy. When low-risk cancer is confined to the prostate, it can be closely monitored with PSA tests, physical exams, serial biopsies and more recently, MRI imaging. This process is known as “active surveillance with curative intent”. With this method, patients only receive active treatment if the cancer becomes more aggressive. This allows individuals to safely delay the side effects of treatment or even avoid them altogether.

The “watchful waiting” strategy is also used for specific situations. When a patient is particularly elderly or ailing, the risk of treatment may outweigh the potential benefits. “Watchful waiting” involves monitoring the situation but not doing active testing (such as biopsies). Action is only taken if the cancer begins to cause symptoms.

Localized Therapies

When cancer is confined to a small area, localized therapies (such as surgery, radiation and ablation) focus only on treating that particular area while the rest of the body is spared. Depending on the situation, if cancerous cells have spread to other parts of the body, these localized approaches may be combined with systemic treatments.

SURGERY

Radical prostatectomy involves the surgical removal of the prostate gland, seminal vesicles and surrounding lymph nodes (in some cases) to cure localized cancer. The surgeon normally takes out the whole prostate gland since prostate cancer is often found in more than one part of the organ, and the more tissue that is removed, the less likely it is that the cancer will return. Along with getting rid of the tumor site, prostate removal allows the doctor to confirm the stage of the cancer, which helps guide any further treatment decisions.

Fox Chase urologic oncologist Dr. Alexander Kutikov works with each patient to determine the best course of action for treatment.





Surgery can be performed in three ways—open, laparoscopic, or robotic—but the experience of the surgeon is always the most important factor:

• Open prostatectomy: A traditional surgery done through an incision underneath the naval.

• Laparoscopic prostatectomy: A surgery performed through much smaller incisions, using long instruments. This leads to shorter recovery times, a shorter hospital stay, and less blood loss.

• Robotic prostatectomy: Using the DaVinci® robotic interface, the surgeon operates through small incisions, similar to laparoscopic methods but with better control to spare surrounding tissue and nerves. More than 80% of modern prostatectomies are currently performed robotically. Fox Chase is at the forefront of using robotic technology to enhance surgical results, and our surgeons are regional leaders in robotic prostatectomy. However, for patients who may not be candidates for the robotic approach, Fox Chase surgeons have extensive experience performing prostate removal using traditional open techniques.

Recovery following robotic surgery typically involves one day in the hospital and a few weeks out of work. In general, patients recover a bit slower following traditional open surgery. Regaining normal urinary and sexual function may take a few months. Risks of permanent side effects also exist, and thus, it is important to discuss these with a physician. At Fox Chase, we monitor and collect data on patients’ surgical outcomes to help improve care and decision-making for all of our patients.

Surgeons at Fox Chase Cancer Center also specialize in treating locally advanced, high-risk prostate cancer. Locally advanced means the cancer has spread beyond the prostate into neighboring areas, but does not appear in distant parts of the body. In such instances, surgery can be combined with other types of therapy (such as radiation therapy) to kill as many cancer cells as possible. Our surgeons also perform “salvage” procedures to treat patients who have had ablative or radiation therapy and develop recurrences. In addition, we offer other types of surgery associated with clinical trials.

PSA AND CANCER RECURRENCEIf the prostate has been removed, monitoring prostate-specific antigen (PSA) levels in the blood is a good way to detect any new growths early on. Only prostate cells produce PSA, so there should be little to none of the antigen in the bloodstream after a prostatectomy. If PSA levels do start to rise, it’s more likely that prostate cancer is growing somewhere. Thus, following a prostatectomy, monitoring is important. The addition of radiation therapy to the area where the prostate was located can be curative for some men whose PSA begins to rise after surgery. In fact, in some high-risk cases, doctors may recommend radiation therapy even if PSA remains undetectable. Such strategy is known as “adjuvant” radiation therapy. At times, physicians at Fox Chase use genomic signature testing to identify potential candidates for this approach.

Fox Chase’s urologic oncologist Dr. David Y.T. Chen works with a multidisciplinary team to develop individualized treatment plans for each patient.





RADIATION THERAPY

Radiation therapy or radiotherapy uses high-energy X-rays (radiation) to destroy prostate cancer cells. To minimize effects on surrounding tissues and organs (such as the bladder and rectum), our team of specialists targets the prostate very precisely. Their goal is to deliver high doses of radiation to the prostate while sparing the normal surrounding organs.

Prostate brachytherapy allows a targeted dose of radiation to be delivered to the prostate. The process confines the treatment and its side effects to a small area. Because of this, it works best for low- to intermediate-risk cancers that have not spread beyond the prostate. It can also be combined with external beam radiation or hormonal therapy for more aggressive cancers.

In brachytherapy, the radiation oncologist places a small amount of radioactive material directly into the prostate.

There are two types of prostate brachytherapy:

• High-dose-rate (HDR) temporary prostate implant: A small amount of radioactive iridium (Ir-192) is placed in the prostate via hollow needles for 15 to 30 minutes. After the dose of radiation is given to the whole prostate, the radiation and needles are removed. The treatment is given twice, typically one week apart.

• Low-dose-rate (LDR) permanent prostate implant, also known as a seed implant: Small radioactive pellets (or “seeds”) containing I-125 are placed throughout the prostate (via hollow needles) in positions that ensure the whole prostate receives a full dose of radiation. Unlike the HDR temporary implant, the I-125 seeds remain in the prostate forever and are not removed, even after they are no longer radioactive. Like the HDR implant, the seed implant is an outpatient surgical procedure done under general anesthesia. Unlike the HDR implant, the seed implant is only done once.

Fox Chase has one of the largest brachytherapy programs in the region and is highly experienced with both HDR and LDR implants. Recently, the radiation oncologists at Fox Chase have been performing more HDR prostate implants because patients continue to achieve excellent clinical results and are experiencing fewer side effects compared to the LDR permanent seed implant.

External beam radiotherapy involves delivering large doses of conformal, or shaped, high-energy X-rays to the prostate using a machine called a linear accelerator, often shortened to LINAC. The most sophisticated external beam radiotherapy technique is called intensity modulated radiation therapy (IMRT). Before the treatment starts, the radiation oncology team conducts a planning session called a simulation, which involves taking a CT scan and an MRI scan of the pelvis. The simulation allows the team to identify the shape of the prostate and the normal surrounding structures to avoid (the bladder and rectum) and plan delivery of the radiation so that it’s as precise as possible. Conventional IMRT is given five days per week for approximately eight weeks. Each treatment takes less than 10 minutes to receive and is painless. Men are able to continue with their daily activities, including work, without interruption.

In hypofractionated radiation therapy, more radiation is delivered per treatment, so fewer days of radiation are required. Individual doses of radiation are often referred to as fractions. The therapy, sometimes also called hypofractionation (fewer fractions), is beneficial because it delivers effective cancer treatment faster than traditional IMRT delivered at conventional fractions. While conventional IMRT therapies usually take seven to eight weeks, hypofractionation can take between two and a half weeks and five and a half weeks. Multiple prostate cancer clinical trials, including one of the largest American studies conducted at Fox Chase Cancer Center, have supported the safety and effectiveness of hypofractionation.

Dr. Eric Horwitz is Chair of the Department of Radiation Oncology at Fox Chase and specializes in the treatment of prostate cancer.





Two types of hypofractionated radiation therapy are used for prostate cancer. Fox Chase radiation oncologists have been performing both of these methods for many years:

• Moderately hypofractionated IMRT: In moderately hypofractionated IMRT, slightly more radiation is given per day so that the entire course of treatment takes approximately five and a half weeks instead of eight weeks. As with conventionally fractionated IMRT, the treatment is delivered five days a week.

• Stereotactic body radiation therapy (SBRT), also known as extreme hypofractionated radiation therapy: With SBRT, much larger doses of radiation are given to the prostate over just five total treatments. The treatment is given two days per week over two and a half weeks. At Fox Chase, SBRT is delivered on regular linear accelerators or the CyberKnife®, a linear accelerator on a robotic arm.

In some cases, radiation oncologists may recommend SpaceOAR®, which is a gel that can be placed during the treatment planning process. The gel is inserted between the rectum and the prostate and helps decrease the amount of radiation to the rectum and some other organs

around the prostate. The gel gradually dissolves and is completely gone approximately six months later.

All modern radiation therapy (both external and internal) minimizes damage to surrounding tissue and structures and involves fewer side effects than surgery. Incontinence and erectile dysfunction, for instance, are less common after radiation therapy than following surgical treatment.

Our radiation oncologists have been at the forefront of developing advanced treatment planning programs for prostate cancer. These programs include real-time treatment planning during procedures for the temporary HDR and permanent LDR prostate implants, Calypso® beacons for IMRT and SBRT patients, and utilizing MRI scans in the treatment planning process.

Along with being a treatment option for prostate cancer that is confined to the prostate, radiation therapy can also be used if the cancer has spread (metastasized) to other parts of the body. In these cases, it can be used to alleviate symptoms in combination with systemic therapy, or for cases of limited metastasis (oligometastatic prostate cancer), it can be used either to delay the start of systemic therapy or combined with systemic therapy for treatment.

IMAGE GUIDANCE FOR RADIATION THERAPYThe radiation treatment team can use three image guidance approaches to ensure that IMRT and SBRT targets the prostate precisely and the radiation dose to the bladder and rectum is minimized:

• CT Scans: The patient receives a daily CT scan immediately before treatment while in position on the treatment table. A computer compares the scan with the original planning CT scan, and small adjustments are made as necessary to ensure that the radiation goes exactly where it should. This process is called localization. The radiation from the daily CT scan is minimal and is incorporated into the total dose of radiation the patient receives, so they are not receiving any extra radiation dose.

• Gold Seeds: A urologic oncologist places four gold seeds in the prostate before the simulation process. Each day, the patient is positioned before treatment based on the location of the gold seeds.

• Calypso® Beacon System: With the Calypso® Beacon System, the radiation oncology team places three radiofrequency transponders, called beacons, in the prostate during the planning process. These beacons allow the team to localize the prostate prior to the start of radiation and monitor movement in real time (called “tracking”) during the treatment so adjustments can be made when necessary. This process assures the radiation oncology team that the prostate is precisely located throughout the entire treatment. Fox Chase is among the world’s most experienced centers in using the Calypso® System.





In some cases, radiation oncologists may recommend SpaceOAR®, which is a gel that can be placed during the treatment planning process. The gel is inserted between the rectum and the prostate and helps decrease the amount of radiation to the rectum and some other organs around the prostate. The gel gradually dissolves and is completely gone approximately six months later.

All modern radiation therapy (both external and internal) minimizes damage to surrounding tissue and structures and involves fewer side effects than surgery. Incontinence and erectile dysfunction, for instance, are less common after radiation therapy than following surgical treatment.

Our radiation oncologists have been at the forefront of developing advanced treatment planning programs for prostate cancer. These programs include real-time treatment planning during procedures for the temporary HDR and permanent LDR prostate implants, Calypso® beacons for IMRT and SBRT patients, and utilizing MRI scans in the treatment planning process.

Dr. Randi J. Cohen has many years of experience with advanced radiation therapies for the treatment of prostate cancer.

ADJUVANT AND SALVAGE POST-PROSTATECTOMY RADIATION THERAPYSometimes, intensity-modulated radiation therapy is given after a patient has had a prostatectomy. There are two situations where this treatment is done. In the first situation, the cancer is discovered to be more extensive than expected, either before or after surgery. The cancer may have penetrated the capsule which surrounds the prostate or extended into the seminal vesicles or the edge of the surgical margin. In this case, physicians may determine (in consultation) that a course of IMRT to the prostate bed and surrounding tissue is needed to reduce the risk of a recurrence and kill any microscopic prostate cancer cells that may be present. The goal of adjuvant post-prostatectomy radiation therapy is to reduce the risk or eliminate a recurrence of cancer in the prostate bed.

In the second situation where IMRT is given after a prostatectomy, evidence of a recurrence in the prostate bed develops months or years after surgery. This is usually discovered by a rising PSA level after surgery. In this situation, treatment called salvage post-prostatectomy IMRT is given to the prostate bed and surrounding tissue to kill the recurrent prostate cancer cells. The goal of this treatment is to eradicate the prostate cancer and lower the PSA level.

For both adjuvant and salvage post-prostatectomy IMRT, treatment is given five days per week for approximately seven weeks. The planning process is similar to those patients receiving IMRT to their prostate. CT and MRI simulations are done prior to the start of treatment to plan the radiation for both adjuvant and salvage post-prostatectomy IMRT.

Daily CT scans or Calypso® beacons for daily localization and tracking are used with both adjuvant and salvage post-prostatectomy radiation therapies.





been identified within the prostate gland. In select men with a potentially aggressive prostate cancer (grade group 2 or higher) that is restricted to a very limited and well-defined location (such that the majority of the prostate gland does not warrant treatment), a focal therapy procedure may appropriately balance treating a man’s prostate cancer while sparing the normal, healthy and unaffected prostate tissue. Focal therapy is appealing because it can minimize treatment side effects, as the surrounding structures do not receive any unnecessary treatment. The procedure has many predicted general benefits over traditional whole gland therapy, including fewer side effects (such as minimal negative impact on urinary, bowel and sexual function), faster recovery time and minimal blood loss.

While focal therapy is promising, it remains an investigational and experimental approach because the longer term benefit and effectiveness on treating prostate cancer is unknown. Urologists at Fox Chase are leading experts on focal therapy, and use it as an alternative treatment option when possible.

ABLATION

Ablative therapies apply extremely high or low temperatures to destroy the prostate gland and the cancer within, normally by using freezing (cryoablation, sometimes called cryosurgery) or heating (using high-frequency ultrasound, or HIFU). Currently, cryoablation and HIFU are not recommended first-line treatment options for men who have not yet been treated. Instead, these techniques are employed more appropriately in men who have a recurrence of prostate cancer or are being examined for an alternative approach to standard whole prostate treatment (focal therapy).

FOCAL THERAPY

Since traditional treatment of the whole prostate can result in significant impact to a man’s baseline urinary and sexual function, there is growing interest in considering men for partial gland treatment if possible (sometimes referred to as focal therapy). Focal therapy is an investigational partial prostate gland therapy that most commonly applies cryoablation or HIFU to target small, discrete areas of prostate cancer that have





SALVAGE TREATMENT FOR PROSTATE CANCERAfter initial treatment for prostate cancer, a urologist and/or radiation oncologist will continue to monitor the patient closely to detect any local recurrence (when the cancer comes back at the original site) or metastasis (spread of the disease). Should the prostate cancer return, which is often suspected if after initial therapy the PSA rises, additional treatment options—referred to as “salvage” treatments—will depend on the tumor location and what types of treatment the patient has already had.

Salvage radiation therapy can be given after a prostatectomy if there is concern or clear evidence of a recurrence in the prostate bed (the region where the prostate was). Intensity-modulated radiation therapy (IMRT) is often utilized to treat the prostate bed. The treatment is given five days per week for approximately seven weeks, and the goal of treatment is to completely eliminate any recurrence, which should result in the person’s PSA levels dropping back to an undetectable level.

If someone had initial radiation treatment and their cancer reoccurs in the prostate (confirmed by testing, including a repeat prostate biopsy), they may be a candidate for robotic salvage prostatectomy, in which the prostate gland is removed using the robotic surgical interface. This approach is carefully considered because radiation treatment often alters the structure of the prostate, making a post-radiation prostatectomy more complicated than a regular one. It is more complicated

due to additional potential side effects and a great need for precision. A second option following radiation treatment of a localized recurrent tumor is salvage cryoablation (freezing), performed in a similar fashion to primary cryoablation. Prostate cryoablation is performed as a single procedure under anesthesia and usually aims to treat the entire prostate gland. Following either salvage prostatectomy or salvage cryoablation treatment, PSA should fall to essentially undetectable levels, acting as a marker of treatment success.

Radiation may also be used as salvage treatment if cancer recurs in the prostate after initial treatment with radiation. Similar to a salvage prostatectomy, a salvage treatment with radiation is more complicated and must be done carefully by experienced and specialized radiation oncologists. Radiation oncologists may use an HDR prostate implant or pulsed low dose rate radiation (PLDR) to deliver more radiation to the prostate. PLDR uses special techniques to deliver radiation using IMRT that is safer than conventional IMRT. To do this safely, each daily treatment of PLDR takes longer to deliver (45 minutes for each treatment).

While salvage treatments may have higher potential risks and complications than up-front primary treatment, they can potentially resolve recurrent prostate cancer and avoid the need for a patient receiving systemic hormone therapy. Fox Chase Cancer Center has considerable experience with complex salvage treatment options.





Systemic Therapies

Systemic therapies are normally used when prostate cancer has spread beyond a confined area or when someone has high-risk localized disease. Systemic therapies include hormone therapy, targeted therapy, chemotherapy, and immunotherapy that can help combat cancerous growths wherever they are located (including ones that are currently too small to detect). This is why systemic therapies are usually the best option for metastatic or advanced cancers, and can improve the quality and length of life for men with prostate cancer. For prostate cancer, especially aggressive prostate cancer, the individual’s care team will often use some combination of systemic and local therapies.

HORMONE THERAPY

Androgen deprivation therapy (also known as hormone therapy) involves reducing the level of male hormones (androgens), especially testosterone, in the body. Since these hormones promote the growth of prostate cancer, depriving the body of androgens usually slows the progression of the cancer. Like chemotherapy, hormone therapy is normally used to combat prostate cancer when it has recurred following surgery or radiation, or for patients who seek medical attention after the disease has spread. For some patients with higher risk localized prostate cancer, a six-month or two-year course of hormone therapy is used in conjunction with radiation therapy. About one-third of men diagnosed with prostate cancer receive hormone therapy. Metastatic prostate tumors find ways to survive and grow, even with low levels of testosterone in the body. However, hormone therapy tends to slow the cancer’s spread and reduce or delay the onset of many symptoms of advanced cancer. It can also be combined with other therapies for a more comprehensive treatment. Hormone therapy has many possible side effects, ranging from sexual dysfunction to muscle weakness and bone density loss.

In the past, the standard way of conducting androgen deprivation therapy was to remove the testes (the organs inside the scrotum that produce most male hormones).

Known as orchiectomy, the procedure is effective and simple, involving only one surgery. It is a viable option, but it is permanent and tends to be infrequently chosen in the United States. Most men prefer alternative hormone therapy techniques (the effects of which are often more reversible). LHRH agonists, for example, interfere with the signals the body uses to initiate testosterone production. They will cause testosterone levels to massively increase for a very short period of time and then drop to almost nothing and remain there. Delivered by an injection, LHRH agonists may be taken at intervals from monthly to yearly (most often given at intervals of three to six months) depending on the specific drug and the dose. Oral LHRH antagonists taken daily are also an option for some individuals. Patients may also receive antiandrogen therapy, alone or in combination with LHRH agonists. Anti-androgens prevent male hormones from binding with cancerous cells. Depending on the situation, an individual may undergo periodic hormone therapy sessions that taper off and pick up again if their cancer comes back or starts to progress. Or they may remain on hormone therapy indefinitely.

Dr. Elizabeth Plimack is Chief of the Division of Genitourinary Medical Oncology at Fox Chase and specializes in treating prostate cancer.





Androgen deprivation therapy is given in conjunction with radiation therapy to men with high-risk prostate cancer. For men with one or more high-risk prognostic features (PSA > 20 ng/mL, Gleason score 8–10, or T3/4 disease), combining long-term androgen deprivation therapy (typically lasting two years) with a full course of intensity-modulated radiation therapy is considered a standard of care treatment. Results from many large clinical trials completed over the past 30 years demonstrate improved cure rates when the two treatments are combined. For some men with intermediate-risk prostate cancer, a shorter course of hormones (four to eight months) can be combined with radiation therapy.

CHEMOTHERAPY

Chemotherapy delivers cancer-fighting chemicals throughout the body via the bloodstream. If a patient has metastatic cancer or their cancer has come back after initial treatment, they’ll normally receive chemotherapy at some point in their treatment course. The most commonly used chemotherapy for advanced prostate cancer is docetaxel (Taxotere®), which interrupts the cycle of growth and division in cancerous cells. There are also other chemotherapy drugs used for prostate cancer, such as cabazitaxel (Jevtana®) and occasionally others. Chemotherapy is usually an outpatient procedure, given in an infusion room through an intravenous (IV) line. Individuals may require a port during their treatment course, which is a special IV placed under the skin of the chest wall. The individual’s care team will work with them to schedule their chemotherapy sessions. Before a patient starts their treatment, their doctor will talk to them about the potential side effects of chemotherapy and discuss how best to manage them. Over the course of their chemotherapy treatments, the individual’s care team will meet with them frequently to discuss their progress and the effects of the treatment. It’s important that the individual lets their care team know about any side effects so they can help them deal with them and adjust their chemotherapy doses appropriately.

IMMUNOTHERAPY

The drug sipuleucel-T (Provenge®) is used for men with prostate cancer that is no longer responding to hormone therapy alone. This is sometimes called castration-resistant prostate cancer (CRPC). Sipuleucel-T is given to men who have cancer that has spread to other parts of the body (metastasized), but who have few to no symptoms. It is tailor-made from the patient’s own immune cells, which are extracted and then treated with a protein that also includes a growth factor (a substance that causes the immune cells to grow and divide). This creates an army of immune cells that will stimulate the patient’s own immune system to recognize, attach to and kill prostate cancer cells. This treatment may not lower PSA, but it has been shown to increase how long men with advanced prostate cancer live.

Other Drug Therapies for Advanced Prostate Cancer

ALPHA EMITTER RADIATION THERAPY (ALPHARADIN, BRAND NAME XOFIGO®)

Alpharadin therapy is used to treat prostate cancer that has spread to the bones. It uses a radioactive substance (radium-223) that gives off a type of high-energy radiation (called an alpha particle) to kill cancer cells. This type of radiation may cause less damage to nearby healthy tissue. This therapy has been proven to improve symptoms and increase how long men with advanced prostate cancer live. Fox Chase oncologists participated in the trials to develop this therapy and frequently use it for their patients.

ENZALUTAMIDE (XTANDI®) AND ABIRATERONE (ZYTIGA®)

Enzalutamide and Abiraterone are hormone therapy pills approved to treat prostate cancer that has metastasized (spread to other parts of the body). They are used together with LHRH agonists and work by further lowering testosterone or preventing testosterone from binding to cancer cells. These medications are now standard of care everywhere, but have long been available to Fox Chase patients as a part of clinical trials.





CLINICAL TRIALS Fox Chase has an active and widely respected clinical trials program. As a patient at Fox Chase, people with both low-risk and high-risk prostate cancer have many opportunities to participate in the search for better and more effective treatments. As the final steps in testing a treatment’s safety and efficacy before it is recommended for general use, clinical trials may give patients access to new procedures that aren’t yet widely available, or to drugs and medical devices before they are approved by the Food and Drug Administration. A clinical trial may also be used to test ideas about diagnosing cancer, preventing cancer, or managing symptoms or side effects. Participating patients agree to let researchers use data on their responses and outcomes (without their names attached) for research purposes. All such programs are carefully developed and approved by regulatory bodies (including Fox Chase’s Institutional Review Board) to minimize any risks or discomfort.

The cancer treatments used today are products of previous clinical trials, and the trials taking place now will help determine how we approach cancer in the future. Cancer care can only advance with the participation of patients, so if you or someone you love is interested in these opportunities, please ask about them. It’s always up to each individual whether they wish to participate, and their doctor will provide them with all the information needed to make an informed decision. Individuals are welcome to review this information with their loved ones or other medical professionals.

The following are examples of groundbreaking state-of-the-art trials that Fox Chase prostate cancer patients have participated in. For a complete list of prostate cancer clinical trials at Fox Chase, please visit our website.

ECOG 3805: https://www.nih.gov/news-events/news-releases/nih-funded-study-shows-increased-survival-men-metastatic-prostate-cancer-who-receive-chemotherapy-when-starting-hormone-therapy

This study showed that patients with newly diagnosed metastatic prostate cancer lived significantly longer if they received chemotherapy in conjunction with hormone therapy as treatment for their cancer (compared to hormone therapy alone).

ABIRATERONE ACETATE: https://www.cancer.gov/about-cancer/treatment/drugs/abirateroneacetate and ENZALUTAMIDE: https://www.cancer.gov/about-cancer/treatment/drugs/enzalutamide

These are hormonal therapies approved for men with metastatic prostate cancer. Fox Chase patients, doctors, and nurses participated in the clinical trials that led to their approvals.

HYPOFRACTIONATED RADIATION THERAPY: http://jco.ascopubs.org/content/31/31/3860

A comprehensive Fox Chase study found that intermediate- and high-risk prostate cancer patients who received precisely targeted radiation therapy in concentrated doses (over a period of five and a half weeks) did just as well as patients who received the standard eight-week treatment. These findings influenced the ongoing transition to shorter therapy periods.

EXTREME HYPOFRACTIONATED STEREOTACTIC BODY RADIATION THERAPY

This study was the first in the country to combine stereotactic body radiation therapy (SBRT) and Calypso® beacon technology, which were used to target a very high dose of radiation to low- and intermediate-risk prostate tumors. Patients received only five radiation treatments instead of the normal 38.

GENETIC EVALUATION

Our genetic evaluation study included men with prostate cancer and men at high risk for developing prostate cancer. The study showed the importance of genetic evaluation for prostate cancer in men with metastatic disease and men with early-stage disease and strong family history.


https://www.foxchase.org/clinical-care/conditions/prostate-cancer/clinical-trials?utm_source=marketo&utm_medium=guide&utm_campaign=foxchase_prostate

http://www.nih.gov/news/health/dec2013/nci-05.htm

https://www.nih.gov/news-events/news-releases/nih-funded-study-shows-increased-survival-men-metastatic-prostate-cancer-who-receive-chemotherapy-when-starting-hormone-therapy

https://www.nih.gov/news-events/news-releases/nih-funded-study-shows-increased-survival-men-metastatic-prostate-cancer-who-receive-chemotherapy-when-starting-hormone-therapy

https://www.cancer.gov/about-cancer/treatment/drugs/abirateroneacetate

https://www.cancer.gov/about-cancer/treatment/drugs/enzalutamide

http://jco.ascopubs.org/content/31/31/3860




PROSTATE CANCER RISK ASSESSMENTIndividuals at high risk of developing prostate cancer may benefit from Fox Chase’s Prostate Cancer Risk Assessment Program (PRAP).

PRAP is an ongoing research, education, and screening program that offers a variety of risk assessment services, including:

• Regular screening and follow-up for early detection of prostate cancer

• Evaluation of family cancer history for a thorough risk assessment

• Genetic testing for eligible individuals

• Feedback regarding lifestyle changes that may lower prostate cancer risk

• Opportunities to participate in prevention research and genetic studies

The program is open to men 35 to 69 years of age who:

• Are African American or black, regardless of their family cancer history

• Have at least one first-degree relative (parent, sibling, or child) with prostate cancer or two second-degree relatives (grandfathers, uncles, or male cousins) with prostate cancer on the same side of the family

• Have tested positive for BRCA1, BRCA2, Lynch Syndrome, ATM, PALB2, CHEK2 or other gene mutations that affect prostate cancer risk

PRAP participants that have a family history suggestive of a genetic predisposition for cancer will be referred to our genetic counselors to discuss genetic testing. If testing reveals genes that put the individual at high risk, they will be followed closely in the program and screened for prostate cancer at least once a year.

GENETIC RISKS FOR PROSTATE CANCERWhile we are still determining the genetic causes of prostate cancer, we do have a good idea about some of the genes involved. For instance, mutations in the genes known as BRCA1 and BRCA2, which are known to promote breast and ovarian cancer, can also increase prostate cancer risk in men. Other genes being examined for their prostate cancer-promoting possibilities are ATM, CHEK2, EPCAM, HOXB13, MLH1, MSH2, MSH6, NBN, PMS2, TP53, ATR, BRIP1, FANCA, GEN1, PALB2, RAD51C, and RAD51D.

Individuals with a diagnosis of prostate cancer may receive genetic testing. For some men with active prostate cancer, the identification of certain genetic mutations can help determine potential treatment options. Additionally, men with a prostate cancer diagnosis may be eligible for ongoing tumor genomic studies, which are developed by researchers in Fox Chase’s PRAP program and genitourinary cancer team.

To schedule an appointment with the prostate risk assessment team, please call 877-627-9684.



We hope that you’ve found this guide to be a useful resource. If you have further questions about prostate cancer, please contact the Fox Chase team at 888-384-8458.

WHY CHOOSE FOX CHASE?Fox Chase Cancer Center:

• Has the highest designation from the National Cancer Institute (NCI) as a Comprehensive Cancer Center, an elite center recognized for excellence in cancer treatment, research, prevention and education

• Offers a multidisciplinary prostate cancer team consisting of leaders in the genitourinary cancer field

• Provides a full spectrum of care for prostate cancer—from detection through survivorship

• Has significant experience with open, endoscopic, laparoscopic, and robotic surgery

• Offers access to clinical trials for emerging and innovative therapies for prostate cancer

When you or someone you care about is faced with the risk or diagnosis of prostate cancer, you’ll want medical advice and care from experienced and compassionate professionals who are leaders in their field. At Fox Chase, we have offered comprehensive approaches to diagnosis, treatment and follow-up support for more than 100 years.

Our multidisciplinary prostate cancer specialists are not only using some of the latest treatments and technology available, but are also involved in clinical trials and risk assessment research. Clinical trials and research may offer patients access to innovative treatments today and breakthroughs in the future. In addition, we take a comprehensive approach to treating your condition, with nurse educators, social workers and other specially trained staff members who truly make a positive difference during a difficult time. These support staff members provide individuals with emotional support, advice and coping strategies when they are needed most.

Temple Health refers to the health, education and research activities carried out by the affiliates of Temple University Health System (TUHS) and by the Lewis Katz School of Medicine at Temple University. TUHS neither provides nor controls the provision of health care. All health care is provided by its member organizations or independent health care providers affiliated with TUHS member organizations. Each TUHS member organization is owned and operated pursuant to its governing documents.

Non-discrimination notice: It is the policy of Fox Chase Cancer Center and Temple University Hospital, Inc., that no one shall be excluded from or denied the benefits of or participation in the delivery of quality medical care on the basis of race, ethnicity, religion, sexual orientation, gender, gender identity/expression, disability, age, ancestry, color, national origin, physical ability, level of education, or source of payment.

© Fox Chase Cancer Center. All rights reserved. 04/2021

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