RecruitingPhase 3NCT01492972

Hypo-fractionated Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Prostate Cancer

Phase III Study of Image Guided Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Adenocarcinoma of the Prostate

Sponsor

Proton Collaborative Group

Enrollment

192 participants

Start Date

Jan 1, 2012

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer

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.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two radiation therapy schedules — a shorter, higher-dose course versus a standard longer course — with or without hormone-blocking therapy, for men with intermediate-risk prostate cancer, to see which approach is most effective with the fewest side effects. **You may be eligible if...** - You have been diagnosed with intermediate-risk prostate cancer (confirmed by biopsy within the past year) - Your cancer meets at least one of these risk factors: a Gleason score of 7 (a measure of how aggressive the cancer looks under a microscope), a PSA level between 10 and 20, or a tumor stage of T2b-T2c - Your cancer has not spread to lymph nodes or other organs **You may NOT be eligible if...** - Your cancer is classified as low-risk or high-risk (not intermediate) - Your cancer has spread beyond the prostate - You have had previous prostate cancer treatment - You have other serious health conditions that would make radiation therapy unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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)

DRUGAndrogen Suppression Therapy

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)