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RECRUITINGINTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Prostate cancer treated primarily with open, laparoscopic or robotically assisted prostatectomy. - Maximum PSA value of 20 ng/ml. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

RADIATION

IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE

Postop High Risk

RADIATION

Proton (prostate bed) to 70.2 CGE

Salvage Non-High Risk

RADIATION

IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE

Salvage High Risk

RADIATION

Proton to 66.6 CGE

Post-Op Non High Risk

Locations (4)

Proton Center of Arkansas
Little Rock, Arkansas, United States
University of Florida Proton Therapy Institute
Jacksonville, Florida, United States
Northwestern Medicine Chicago Proton Center
Warrenville, Illinois, United States
Inova Schar Cancer Institute
Fairfax, Virginia, United States