Metastatic Castration Resistant Prostate peer c.pdfآ  Metastatic Castration Resistant Prostate Cancer

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  • Metastatic Castration Resistant Prostate Cancer Must we treat asymptomatic disease?

    Avivit Peer

    Oncology Institute

    Rambam Health Care Campus

    Haifa, Israel

  • D is

    e as

    e B

    u rd

    e n

    Castration

    1st-line therapies

    Local therapy

    2nd-line hormonal therapy

    2nd-line therapies

    Disease continuum in prostate cancer

    2

    Asymptomatic

    CRPC

    Metastatic

    Hormone-sensitive

    Symptomatic

    Time

    Non-metastatic

    HEIDENREICH A, ET AL. EUR UROL. 2013;64(2):260-265.

    Additional therapies

  • Asymptomatic mcPCa Mild Symptomatic mcPCa Very Symptomatic mcPCa

    Early vs Late treatment

  • A. Orsola. European Urology 2014

  • 7

    Stratification into 2 groups:

    • Group 1: asymptomatic/no pain (BPI-SF 0-1), PSA < 80 ng/mL and Gleason score < 8

    – AA + P: 124/546 subjects (23%)

    – P: 140/542 subjects (26%)

    • Group 2: any of the following – mildly symptomatic mild pain (BPI-SF ≥ 2), PSA ≥ 80 ng/mL or Gleason score ≥ 8

    – AA + P: 422/546 subjects (77%)

    – P: 402/542 subjects (74%)

    Miller K, et al. Poster (#775) presented at the 31st Annual EAU Congress, 11-15 March 2016, Munich, Germany

    The Phase 3 COU-AA-302 Study of Abiraterone Acetate in Men With Chemotherapy-Naïve Metastatic Castration- Resistant Prostate Cancer: Stratified Analysis Based on

    Pain, Prostate-Specific Antigen and Gleason Score

  • 8

    AA + P Significantly Prolonged OS and rPFS versus P Alone in Groups 1 (asymptomatic, PSA < 80 GS < 8)

    and Groups 2 (mildly symptomatic, PSA ≥ 80, GS ≥ 8)

    Median OS Group 1 AA + P: 53.6 months P: 41.8 months HR=0.61 (95% CI: 0.43-0.87) p=0.0055

    Median OS Group 2 AA + P: 31.2 months P: 28.4 months HR=0.84 (95% CI: 0.72-0.99) p=0.0321

    Median rPFS Group 1 AA + P: 27.6 months P: 11.1 months HR=0.41 (95% CI: 0.30-0.57) p

  • 9

    Time to Chemotherapy use and Time to Opiate use versus P Alone in Groups 1 and 2

    Median time to chemotherapy use Group 1

    AA + P: 37.0 months P: 24.3 months

    HR=0.64 (95% CI: 0.46-0.89) p=0.0073

    Median time to chemotherapy use Group 2

    AA + P: 23.3 months P: 14.5 months

    HR=0.71 (95% CI: 0.60-0.85) p=0.0001

    Median time to opiate use Group 1

    AA + P: NR P: 41.0 months

    HR=0.69 (95% CI: 0.48-0.99) p=0.0409

    Median time to opiate use Group 2

    AA + P: 30.5 months P: 19.3 months

    HR=0.70 (95% CI: 0.59-0.84) p=0.0001

    Miller K, et al. Poster (#775) presented at the 31st Annual EAU Congress, 11-15 March 2016, Munich, Germany

  • WCDT

    Presented By Scott Tomlins at 2015 ASCO Annual Meeting

  • Slide 42

    Presented By Robert Dreicer at 2015 ASCO Annual Meeting

  • Why Earlier?

    - rPFS √ - OS √ - Time to chemotherapy √ - Time to opiate use √

  • So, how early is early enough?

    M, 59, mCRPC

    PSMA-PET/CT uptake in:

    • Primary tumor in prostate

    • Pelvic LNs (up to 12mm)

    • Lytic lesions lt. pelvis & T6.

  • M, 65, Prostate Ca, Rising PSA Ga68 PSMA

    LN metastases SUVmax 10.3

    T9 vertebral met SUVmax 11.14

  • What is the real volume of the disease? Bone scan flare following initiation of NHT

    1.2015 4.2015 06.2015

  • Background

  • Feb 2018

  • Slide 5

    SPARTAN Phase III study

    Presented By Eric Small at 2018 Genitourinary Cancers Symposium

  • 66 YM, CRPC , Rising PSA Negative bone scan, chest+abdomanal CT

  • Slide 8

  • Slide 9

  • Slide 11

  • PROSPER Study Design

  • Subgroup Analysis of MFS

  • Time to PSA Progression

  • Slide 16