Proton Therapy for Low and Intermediate Risk Prostate Cancer (PR04)

September 15, 2023 updated by: University of Florida

A Phase II Study of Hypofractionated 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 weeks) of radiation that has as little side effects on normal bladder and rectal tissues as the usual longer course (8 weeks) of radiation, without decreasing the chance of killing prostate cancer cells.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Low Risk - Total of 70 Gy/CGE over 28 treatments

Intermediate Risk - Total of 72.5 Gy/CGE over 29 treatments

Study Type

Interventional

Enrollment (Actual)

228

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, 32206
        • 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 2-7.
  • PSA ≤ 20 ng/ml.

Exclusion Criteria:

  • Previous prostate cancer surgery or pelvic radiation.
  • Prior or current chemotherapy for prostate cancer.
  • Active inflammatory bowel disease (Crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum.
  • History of proximal urethral stricture requiring dilatation.
  • History of hip replacement.
  • Diabetes requiring medication.
  • Prior intrapelvic surgery.
  • Current and continuing anticoagulation with Warfarin sodium (Coumadin), Clopidogrel bisulfate (Plavix), enoxaparin sodium (Lovenox), or aspirin/er dipyridamole (Aggrenox).
  • On Flomax (Tamsulosin), Hytrin (Terazosin) or Cardura (Doxazosin), Uroxatral (alfuzosin HCl).
  • 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: Low Risk Proton Radiation
70 Gy/CGE in 28 fractions of 2.5 Gy/CGE/fx
Radiation: Low Risk Proton Radiation
Experimental: Intermediate Risk Proton Radiation
72.5 GY/CGE in 29 fractions of 2.5 Gy/CGE/fx
Radiation: Intermediate Risk Proton Radiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Acute Grade 3 (NCI CTC v4.0) or Higher Treatment-related Toxicity Rate.
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
Disease Control
Time Frame: 20 years after end of radiation
20 years after end of radiation

Collaborators and Investigators

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

Sponsor

University of Florida

Investigators

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

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

April 1, 2008

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

April 25, 2022

Study Registration Dates

First Submitted

June 4, 2008

First Submitted That Met QC Criteria

June 5, 2008

First Posted (Estimated)

June 6, 2008

Study Record Updates

Last Update Posted (Actual)

September 18, 2023

Last Update Submitted That Met QC Criteria

September 15, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UFPTI 0702-PR04
  • IRB201701653 (Other Identifier: UF IRB)
  • UFJ 2008-022 (Other Identifier: UF IRB Old)

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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