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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorProton Collaborative Group

About this trial

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 criteria

Qualifiers

Prostate cancer treated primarily with open, laparoscopic or robotically assisted prostatectomy.

Maximum PSA value of 20 ng/ml.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • 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

Treatment groups

70 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Proton Collaborative Group

Lead sponsor

University of Florida Health

Collaborator