SRAM study_Postate Cancer

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

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)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CCTU
• Treatments: Androgens

Criteria

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.