Radiation Therapy for Prostate Cancer After Surgery

This study is looking at different types of radiation therapy for men with prostate cancer who have already had surgery (radical prostatectomy). The goal is to see how effective and safe proton radiation and/or conventional radiation (IMRT) are at treating prostate cancer that has returned or is at high risk of returning. You might be able to join if you are a man aged 18 or older, have had prostatectomy for prostate cancer, and your highest PSA (prostate-specific antigen) level was 20 ng/ml or less. You cannot have cancer that has spread to distant parts of your body or have had prior chemotherapy or radiation to your pelvis. The study will measure how many participants experience severe side effects related to their stomach, intestines, or urinary system within six months after finishing radiation therapy. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of 70 participants. It is not specified if it is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 6 months after the end of radiation therapy to assess for acute side effects.

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NCT00969111

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

Recruiting
NAAges 18+InterventionalTreatment
Proton Collaborative Group
~70 participants
Updated 2026-06-17 on ClinicalTrials.gov
What's tested:IMRT to 45 Gy; prostate bed proton boost of 21.6 CGEProton (prostate bed) to 70.2 CGEIMRT to 45 Gy; proton boost to prostate bed to 25.2 CGEProton to 66.6 CGE

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The treatment-related rate of acute grade 3 gastrointestinal and genitourinary toxicity following treatment with proton based radiation therapy.
Measured over 6 months after the end of radiation therapy
Prostate Cancer
6 sites across 6 states
Arkansas1
Florida1
Illinois1
Michigan1
Missouri1
Virginia1
  • Samuel Jean-Baptiste, MD · PRINCIPAL_INVESTIGATOR · University of Florida

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Eligibility criteria

Inclusion

Prostate cancer treated primarily with open, laparoscopic or robotically assisted prostatectomy.
Maximum PSA value of 20 ng/ml.

Exclusion

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.
  • The treatment-related rate of acute grade 3 gastrointestinal and genitourinary toxicity following treatment with proton based radiation therapy.6 months after the end of radiation therapy