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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low Risk Proton Radiation
Intermediate Risk Proton Radiation
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, Proton Radiation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Florida Proton Therapy Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low Risk Proton Radiation

Intermediate Risk Proton Radiation

Arm Description

70 Gy/CGE in 28 fractions of 2.5 Gy/CGE/fx

72.5 GY/CGE in 29 fractions of 2.5 Gy/CGE/fx

Outcomes

Primary Outcome Measures

Acute Grade 3 (NCI CTC v4.0) or Higher Treatment-related Toxicity Rate.

Secondary Outcome Measures

Disease Control

Full Information

First Posted
June 4, 2008
Last Updated
September 15, 2023
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT00693238
Brief Title
Proton Therapy for Low and Intermediate Risk Prostate Cancer
Acronym
PR04
Official Title
A Phase II Study of Hypofractionated Image Guided Proton Radiation Therapy for Low and Intermediate Risk Adenocarcinoma of the Prostate
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
April 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
Low Risk - Total of 70 Gy/CGE over 28 treatments Intermediate Risk - Total of 72.5 Gy/CGE over 29 treatments

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, Proton Radiation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
228 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Risk Proton Radiation
Arm Type
Experimental
Arm Description
70 Gy/CGE in 28 fractions of 2.5 Gy/CGE/fx
Arm Title
Intermediate Risk Proton Radiation
Arm Type
Experimental
Arm Description
72.5 GY/CGE in 29 fractions of 2.5 Gy/CGE/fx
Intervention Type
Radiation
Intervention Name(s)
Low Risk Proton Radiation
Intervention Type
Radiation
Intervention Name(s)
Intermediate Risk Proton Radiation
Primary Outcome Measure Information:
Title
Acute Grade 3 (NCI CTC v4.0) or Higher Treatment-related Toxicity Rate.
Time Frame
6 months after the end of radiation therapy
Secondary Outcome Measure Information:
Title
Disease Control
Time Frame
20 years after end of radiation

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randal H Henderson, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida Proton Therapy Institute
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32206
Country
United States

12. IPD Sharing Statement

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Links:
URL
https://www.floridaproton.org/about-us/contact-us
Description
Contact the University of Florida Proton Therapy Institute

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Proton Therapy for Low and Intermediate Risk Prostate Cancer

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