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

Primary Purpose

Prostate Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
70 Gy/CGE
72.5 Gy/CGE
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 Proton Radiation, Prostate Cancer

Eligibility Criteria

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

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).

Sites / Locations

  • University of Florida Proton Therapy Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low Risk

Intermediate Risk

Arm Description

70 Gy/CGE

72.5 Gy/CGE

Outcomes

Primary Outcome Measures

Cumulative incidence of treatment-related grade 2 or higher rectal bleeding.

Secondary Outcome Measures

Analyzation of quality of life
Analysis of treatment-related morbidity
Analysis of disease control
Proportion of patients with disease control after completion of treatment
Analysis of overall survival
Proportion of patients alive after completion of treatment

Full Information

First Posted
June 1, 2011
Last Updated
September 15, 2023
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT01368055
Brief Title
Hypofractionated Proton Radiation Therapy for Low and Intermediate Risk Prostate Cancer
Acronym
PR07
Official Title
An Expanded Phase II Study of Hypofractionated Dose Intense 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
Active, not recruiting
Study Start Date
September 2011 (Actual)
Primary Completion Date
September 2036 (Anticipated)
Study Completion Date
September 2036 (Anticipated)

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 ½-6 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.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Low Risk
Arm Type
Experimental
Arm Description
70 Gy/CGE
Arm Title
Intermediate Risk
Arm Type
Experimental
Arm Description
72.5 Gy/CGE
Intervention Type
Radiation
Intervention Name(s)
70 Gy/CGE
Intervention Description
Low Risk
Intervention Type
Radiation
Intervention Name(s)
72.5 Gy/CGE
Intervention Description
Intermediate Risk
Primary Outcome Measure Information:
Title
Cumulative incidence of treatment-related grade 2 or higher rectal bleeding.
Time Frame
2 years after completion of radiation therapy
Secondary Outcome Measure Information:
Title
Analyzation of quality of life
Time Frame
After radiation: every 6 months for 3 years, then annually for 20 years
Title
Analysis of treatment-related morbidity
Time Frame
Cumulative incidence up to 20 years after completion of radiation therapy
Title
Analysis of disease control
Description
Proportion of patients with disease control after completion of treatment
Time Frame
Cumulative incidence up to 20 years after completion of radiation therapy
Title
Analysis of overall survival
Description
Proportion of patients alive after completion of treatment
Time Frame
Cumulative incidence up to 20 years after completion of radiation therapy

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randal H. Henderson, MD, MBA
Organizational Affiliation
University of Florida Proton Therapy Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida Proton Therapy Institute
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
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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Hypofractionated Proton Radiation Therapy for Low and Intermediate Risk Prostate Cancer

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