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RecruitingInterventional
Postoperative or Salvage Radiotherapy for Node Negative Prostate Cancer Following Radical Prostatectomy
NCT ID: NCT00969111Sponsor: Proton Collaborative GroupLast updated: 2026-06-17
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.
Arms & 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
Outcome measures
Primary
The treatment-related rate of acute grade 3 gastrointestinal and genitourinary toxicity following treatment with proton based radiation therapy.
Time frame: 6 months after the end of radiation therapy
Secondary
Collect and analyze quality of life, treatment-related morbidity, disease control and survival outcome parameters
Time frame: After radiation: every 6 months for 3 years, then annually for 20 years
Eligibility criteria
Sex: MaleAge: 18 Years and olderHealthy volunteers: No
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.
Study locations (6)
Proton Center of Arkansas
Little Rock, Arkansas, 72205
Sanjay Maraboyina, MD · Principal Investigator
University of Florida Proton Therapy Institute
Jacksonville, Florida, 32206
Samuel Jean-Baptiste, MD · Principal Investigator
Northwestern Medicine Chicago Proton Center
Warrenville, Illinois, 60555
Arpi Thukral, MD · Principal Investigator
McLaren Proton Therapy Center
Flint, Michigan, 48532
Brian Yeh, MD · Principal Investigator
Mercy David C. Pratt Cancer Center
St Louis, Missouri, 63141
Amit Roy, MD · Principal Investigator
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Kevin Choe, MD · Principal Investigator
References
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