RecruitingNot ApplicableNCT00969111
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
Sponsor
Proton Collaborative Group
Enrollment
70 participants
Start Date
Aug 1, 2009
Study Type
INTERVENTIONAL
Conditions
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
Sex: MALEMin Age: 18 Years
Plain Language Summary
Simplified for easier understanding
This study is examining whether radiation therapy given after prostate removal surgery (either immediately after or as a salvage treatment if PSA rises) affects long-term outcomes, focusing on side effects and quality of life in men with node-negative prostate cancer.
**You may be eligible if...**
- You had your prostate removed (open, laparoscopic, or robotic surgery) as primary treatment for prostate cancer
- Your pre-surgery PSA was 20 ng/mL or lower
**You may NOT be eligible if...**
- Your cancer has spread to distant sites (metastasis)
- You have previously received chemotherapy for any reason
- You have had prior pelvic radiation that would interfere with the planned treatment
- You have active inflammatory bowel disease affecting the rectum
- You have had a hip replacement
- You have another active cancer (except non-melanoma skin cancer) within the last 5 years
- You are taking Saw Palmetto or methotrexate and unwilling to stop during radiation
Talk to your doctor to see if this trial is right for you.
This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interventions
RADIATIONIMRT to 45 Gy; prostate bed proton boost of 21.6 CGE
Postop High Risk
RADIATIONProton (prostate bed) to 70.2 CGE
Salvage Non-High Risk
RADIATIONIMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE
Salvage High Risk
RADIATIONProton to 66.6 CGE
Post-Op Non High Risk
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT00969111
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