Postoperative or Salvage Radiotherapy (RT) for Node Negative Prostate Cancer Following Rad
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.
| Condition(s) | Prostate Cancer |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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 d |
| Ages | 18 Years |
| Sex | Male |
| Lead sponsor | Proton Collaborative Group |
| Locations | Little Rock, Arkansas, United States; Jacksonville, Florida, United States; Warrenville, Illinois, United States; Fairfax, Virginia, United States |
| Start date | 2009-08 |
| NCT ID | NCT00969111 |
| Official listing | https://clinicaltrials.gov/study/NCT00969111 |