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
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