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

RecruitingNAAges 18 Years - anyMaleProton Collaborative Group
NCT00969111 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE
  • Proton (prostate bed) to 70.2 CGE
  • IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE
  • Proton to 66.6 CGE
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Where

6 sites
Proton Center of Arkansas
Little Rock, United States
University of Florida Proton Therapy Institute
Jacksonville, United States
Northwestern Medicine Chicago Proton Center
Warrenville, United States
McLaren Proton Therapy Center
Flint, United States
Mercy David C. Pratt Cancer Center
St Louis, United States
Inova Schar Cancer Institute
Fairfax, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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