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

September 2, 2025 updated by: Proton Collaborative Group

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • Proton Center of Arkansas
        • Contact:
        • Principal Investigator:
          • Sanjay Maraboyina, MD
    • Florida
      • Jacksonville, Florida, United States, 32206
        • Recruiting
        • University of Florida Proton Therapy Institute
        • Contact:
          • Intake Coordinator
          • Phone Number: 877-686-6009
        • Principal Investigator:
          • Randal H Henderson, MD
    • Illinois
      • Warrenville, Illinois, United States, 60555
        • Recruiting
        • Northwestern Medicine Chicago Proton Center
        • Contact:
        • Principal Investigator:
          • Arpi Thukral, MD
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Inova Schar Cancer Institute
        • Principal Investigator:
          • Kevin Choe, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).
  • History of hip replacement.
  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Postop Non-High Risk
Proton to 66.6 CGE
Radiation: Proton to 66.6 CGE
Post-Op Non High Risk
Experimental: Postop High Risk
IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE
Radiation: IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE
Postop High Risk
Experimental: Salvage Non-High Risk
Proton to 70.2 CGE
Radiation: Proton (prostate bed) to 70.2 CGE
Salvage Non-High Risk
Experimental: Salvage High Risk
IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE
Radiation: IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE
Salvage High Risk

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 months after the end of radiation therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
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
After radiation: every 6 months for 3 years, then annually for 20 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Proton Collaborative Group

Collaborators

University of Florida Health

Investigators

  • Principal Investigator: Randal H Henderson, MD, University of Florida Proton Therapy Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Estimated)

August 1, 2031

Study Completion (Estimated)

August 1, 2050

Study Registration Dates

First Submitted

August 28, 2009

First Submitted That Met QC Criteria

August 28, 2009

First Posted (Estimated)

August 31, 2009

Study Record Updates

Last Update Posted (Estimated)

September 9, 2025

Last Update Submitted That Met QC Criteria

September 2, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GU010-18
  • UFPTI 0902-PR06 (Other Identifier: University of Florida Health Proton Therapy Institute)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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