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Recruiting NCT00969111

Postoperative or Salvage Radiotherapy (RT) for Node Negative Prostate Cancer Following Radical Prostatectomy

Trial Parameters

Condition Prostate Cancer
Sponsor Proton Collaborative Group
Study Type INTERVENTIONAL
Phase N/A
Enrollment 70
Sex MALE
Min Age 18 Years
Max Age N/A
Start Date 2009-08
Completion 2031-08
Interventions
IMRT to 45 Gy; prostate bed proton boost of 21.6 CGEProton (prostate bed) to 70.2 CGEIMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE

Brief Summary

The purpose of this study is to see what effects, good and/or bad, proton radiation, and/or conventional radiation and hormonal therapy (if applicable), has on prostate cancer that has already returned or the risk of prostate cancer returning.

Eligibility Criteria

Inclusion Criteria: * Prostate cancer treated primarily with open, laparoscopic or robotically assisted prostatectomy. * Maximum PSA value of 20 ng/ml. Exclusion Criteria: * Evidence of distant metastasis (M1). * Prior systemic chemotherapy for any reason. * Previous irradiation to the pelvis that would compromise the ability to deliver the prescribed study treatment. * Active inflammatory bowel disease (Crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum. (Non-active diverticulitis and Crohn's disease not affecting the rectum are allowed). * History of hip replacement. * Prior or concurrent cancer, other than non-melanomatous skin cancer, unless disease free for at least 5 years. * Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.

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