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SRAM study_Postate Cancer

SRAM study_Postate Cancer

Non Recruiting
18 years and older
Male
Phase 2

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Overview

This is a phase 2 randomized study for High risk localized prostate cancer (T3 to T4 disease and/or PSA > 20 and/or Gleason score ≥ 8) without evidence of distant and nodal metastasis.

Patient will be randomized to:Arm 1

  • Conventional IMRT RapidArc IMRT to prostate and pelvic nodes. 76Gy to prostate, 70Gy to proximal 2/3 of seminal vesicles, and 50Gy to pelvic nodes (up to bifurcation of common iliac nodes).
  • 38 fractions of daily treatment, Monday to Friday

or Arm 2

SBRT

  • RapidArc IMRT to prostate and pelvic nodes. 40Gy to prostate, 36.25Gy to proximal 2/3 of seminal vesicles, and 25Gy to pelvic nodes (up to bifurcation of common iliac nodes)
  • 5 fractions of weekly treatment. Once fraction per week. All patients will be given neoadjuvant and adjuvant androgen deprivation therapy (detail as below)

Eligibility

Inclusion Criteria:

  • Histological confirmation of prostate adenocarcinoma
  • High risk prostate cancer patients (i.e. T3 to T4 disease and/or PSA > 20 and/or Gleason score ≥ 8)
  • ECOG performance score 0-1
  • Age ≥ 18
  • History/physical examination within 2 weeks prior to registration
  • Able to sign informed-consent

Exclusion Criteria:

  • Patients with active cancer other than prostate cancer and non-melanoma skin cancer.
  • Evidence of distant metastases
  • Regional lymph node involvement
  • Previous radical surgery (prostatectomy), cryosurgery, or HIFU for prostate cancer
  • Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
  • Previous hormonal therapy, such as LHRH agonists (e.g., goserelin, leuprolide) or LHRH antagonists (e.g., degarelix), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g. DES), or surgical castration (orchiectomy)
  • Unstable angina and/or congestive heart failure requiring hospitalization, transmural myocardial infarction within the last 6 months, acute bacterial or fungal infection requiring intravenous antibiotics, chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
  • Patients who have received prior chemotherapy.

Study details
    Advanced Prostate Cancer

NCT03938649

CCTU

20 August 2025

FAQs

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