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NCT00969111NARecruiting

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

Proton Collaborative Group

Start Date

8/1/2009

Completion Date

8/1/2050

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

Age Range: 18 years to No maximum

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). * 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.

Interventions

RADIATION

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

RADIATION

Proton (prostate bed) to 70.2 CGE

RADIATION

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

RADIATION

Proton to 66.6 CGE

Interested in This Trial?

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Conditions

Prostate Cancer

Locations

Proton Center of Arkansas

Little Rock, Arkansas 72205

United States

University of Florida Proton Therapy Institute

Jacksonville, Florida 32206

United States

Northwestern Medicine Chicago Proton Center

Warrenville, Illinois 60555

United States

McLaren Proton Therapy Center

Flint, Michigan 48532

United States

Mercy David C. Pratt Cancer Center

St Louis, Missouri 63141

United States

Inova Schar Cancer Institute

Fairfax, Virginia 22031

United States