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)

Northwestern Medicine Chicago Proton Center

Warrenville, Illinois, United States

Inova Schar Cancer Institute

Fairfax, Virginia, United States

University of Florida Proton Therapy Institute

Jacksonville, Florida, United States

Proton Center of Arkansas

Little Rock, Arkansas, United States

View Full Details on ClinicalTrials.gov

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NCT00969111


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