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Clinical trial Recruiting at 6 sites Interventional Ages 18 and up Men only

Proton and conventional radiation for prostate cancer after surgery

Official title: Postoperative or Salvage Radiotherapy for Node Negative Prostate Cancer Following Radical Prostatectomy

Run by Proton Collaborative Group · NCT00969111 · Data updated 2026-11-12

This study is testing whether proton radiation or conventional radiation with hormone therapy can help men with recurring prostate cancer after surgery feel better and improve their chances of recovery.

Quick facts

Study typeInterventional
Ages18 Years and up
SexMen only
Enrollment70 (estimated)
SponsorProton Collaborative Group
Research network
Drugs / interventionschemotherapy, radiation, methotrexate
Locations6 sites (Little Rock, Arkansas and 5 other locations)
StatusRecruiting
StartedAugust 2009
Main results expectedAugust 2031
Study endsAugust 2050
Registry record updatedJune 17, 2026
Trial IDNCT00969111 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are men who have undergone radical prostatectomy for prostate cancer and have a maximum PSA value of 20 ng/ml.

Probably not a fit

Patients with evidence of distant metastasis, prior systemic chemotherapy, or active inflammatory bowel disease affecting the rectum may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of proton radiation and conventional radiation combined with hormonal therapy on prostate cancer that has recurred or has a risk of returning after radical prostatectomy. Patients will receive various radiation treatments, including intensity-modulated radiation therapy (IMRT) and proton boosts to the prostate bed. The study aims to evaluate both the positive and negative effects of these treatments on prostate cancer outcomes.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with recurrent prostate cancer, potentially improving their prognosis.

How similar studies have gone: Other studies have shown promise with proton therapy for prostate cancer, indicating that this approach is gaining traction in the field.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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.

Where it's running

  • Proton Center of Arkansas
    Little Rock, Arkansas, United States     Recruiting
  • University of Florida Proton Therapy Institute
    Jacksonville, Florida, United States     Recruiting
  • Northwestern Medicine Chicago Proton Center
    Warrenville, Illinois, United States     Recruiting
  • McLaren Proton Therapy Center
    Flint, Michigan, United States     Recruiting
  • Mercy David C. Pratt Cancer Center
    St Louis, Missouri, United States     Recruiting
  • Inova Schar Cancer Institute
    Fairfax, Virginia, United States     Recruiting

Study contacts

  • Principal investigator: Samuel Jean-Baptiste, MD — University of Florida

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Prostate Cancer 1464Proton Collaborative Group 6
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.