Hypofractionated Proton Radiation Therapy for Low and Intermediate Risk Prostate Cancer (PR07)

August 28, 2025 updated by: University of Florida

An Expanded Phase II Study of Hypofractionated Dose Intense Image Guided Proton Radiation Therapy for Low and Intermediate Risk Adenocarcinoma of the Prostate

The purpose of this trial is to give a shorter course (5 ½-6 weeks) of proton radiation that has as little side effects on normal bladder and rectal tissues as the usual longer course (8 weeks) of proton radiation, without decreasing the chance of killing prostate cancer cells.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

361

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 Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32209
        • University of Florida Proton Therapy Institute

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.
  • Gleason score 2-6 or 7.
  • PSA ≤ 20 ng/ml.

Exclusion Criteria:

  • Previous prostate cancer surgery or pelvic radiation.
  • Prior/concurrent systemic chemotherapy for prostate cancer.
  • Active inflammatory bowel disease (Crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum.
  • History of hip replacement.
  • Prior intrapelvic surgery.
  • Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its uses during radiation.
  • Receiving continuous and current anticoagulation with Warfarin sodium (Coumadin), Clopidogrel bisulfate (Plavix), dabigatran etexilate mesylate (Pradaxa),enoxaparin sodium (Lovenox), or aspirin/er dipyridamole (Aggrenox).

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: Low Risk
70 Gy/CGE
Radiation: 70 Gy/CGE
Low Risk
Experimental: Intermediate Risk
72.5 Gy/CGE
Radiation: 72.5 Gy/CGE
Intermediate Risk

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cumulative incidence of treatment-related grade 2 or higher rectal bleeding.
Time Frame: 2 years after completion of radiation therapy
2 years after completion of radiation therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analyzation of quality of life
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
Analysis of treatment-related morbidity
Time Frame: Cumulative incidence up to 20 years after completion of radiation therapy
Cumulative incidence up to 20 years after completion of radiation therapy
Analysis of disease control
Time Frame: Cumulative incidence up to 20 years after completion of radiation therapy
Proportion of patients with disease control after completion of treatment
Cumulative incidence up to 20 years after completion of radiation therapy
Analysis of overall survival
Time Frame: Cumulative incidence up to 20 years after completion of radiation therapy
Proportion of patients alive after completion of treatment
Cumulative incidence up to 20 years after completion of radiation therapy

Collaborators and Investigators

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

Sponsor

University of Florida

Investigators

  • Principal Investigator: Curtis Bryant, MD, MPH, 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

Helpful Links

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 (Actual)

September 1, 2011

Primary Completion (Actual)

August 1, 2025

Study Completion (Actual)

August 1, 2025

Study Registration Dates

First Submitted

June 1, 2011

First Submitted That Met QC Criteria

June 6, 2011

First Posted (Estimated)

June 7, 2011

Study Record Updates

Last Update Posted (Estimated)

August 29, 2025

Last Update Submitted That Met QC Criteria

August 28, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UFPTI 1103-PR07
  • IRB201701768 (Other Identifier: University of Florida)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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