CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 192 target
Drug / intervention
Androgen Suppression Therapy +1 moredrug
Likely dose
Not stated in record
Key inclusion· 9
  • ✓Histologically confirmed prostate adenocarcinoma within 365 days of randomization
  • ✓Intermediate risk by Gleason Score 7, PSA ≥10 and ≤20, or T stage T2b-T2c
  • ✓Clinical stages T1-T2c N0 M0
  • ✓Gleason score 2-7 on prostate biopsy
Key exclusion· 11
  • ✕Pelvic lymph nodes >1.5 cm unless biopsied and negative
  • ✕Previous prostate cancer surgery including prostatectomy, hyperthermia, cryosurgery
  • ✕Previous pelvic radiation for prostate cancer
  • ✕Previous androgen suppression therapy for prostate cancer

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01492972
NCT01492972Phase 3RecruitingOn TrackUpdated 9mo ago
Long Recruiting
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Phase III Study of Image Guided Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Adenocarcinoma of the Prostate

Proton Collaborative Group·interventional·Posted Dec 15, 2011·Updated Sep 4, 2025

In Brief

A Phase 3 clinical trial evaluating Radiation and Androgen Suppression Therapy for Prostate Cancer. Currently recruiting, targeting 192 participants across 4 sites.

Detailed Summary

The purpose of this study is to compare the effects, good and/or bad of two treatment methods on subjects and their cancer. Proton beam radiation therapy is one of the treatments for men with prostate cancer who have localized disease. The benefit of the combination with androgen suppression is not completely understood. This study will compare the use of hypofraction proton therapy (28 treatments) alone to proton therapy with androgen suppression therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 3Recruiting
20122013201420152016201720182019202020212022202320242025202620272028
First PostedDec 15, 2011
Enrollment StartJan 1, 2012
Primary CompletionDec 1, 2027
TodayJul 2, 2026
Enrollment to primary: 15.9 yearsPosted 14.5 years agoPrimary completion in 1.4 years

Interventions

Radiationradiation

Consists of: 1. Conformal Proton Radiation Dose: 2.5 Gy (RBE) five days a week in 28 treatments over 5.5-6.5 weeks (total dose: 70 Gy (RBE)) 2. High Dose Radiation with IMRT alone: 1.8 Gy five days a week in 45 treatments over 9-10 weeks (total dose: 81 Gy) 3. Intraoperative LDR Brachytherapy and IMRT: 100Gy Pad103 implant and IMRT 1.8 Gy five days a week in 25 treatments over 5-6 weeks (total dose: 45 Gy)

Androgen Suppression Therapydrug

Androgen suppression will begin 8 - 10 weeks prior to the start of RT for a total of 6 (+/- 2) months. Luteinizing Hormone-Releasing Hormone (LHRH) agonist therapy will consist of analogs approved by the FDA (or by Health Canada for Canadian institutions)