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Proton Beam Therapy
Short-course Proton Radiation for Prostate Cancer (PR07 Trial)
N/A
Waitlist Available
Led By Randal H. Henderson, MD, MBA
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Gleason score 2-6 or 7
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years after completion of radiation therapy
Awards & highlights
PR07 Trial Summary
This trial is testing a shorter course of proton radiation to see if it is just as effective as the usual longer course, with fewer side effects.
Who is the study for?
Men with prostate cancer who have a PSA level of 20 ng/ml or lower and a Gleason score between 2-7 can join this trial. They shouldn't have had previous prostate cancer surgery, pelvic radiation, certain intrapelvic surgeries, systemic chemotherapy for prostate cancer, or be on specific anticoagulants like Warfarin.Check my eligibility
What is being tested?
The trial is testing two different doses of proton radiation therapy (70 Gy/CGE and 72.5 Gy/CGE) to see if a shorter treatment duration (5½-6 weeks) is as effective and has fewer side effects compared to the standard longer course (8 weeks).See study design
What are the potential side effects?
Proton radiation therapy may cause side effects such as irritation to the bladder and rectum, fatigue, skin changes in treated areas, urinary issues, and bowel changes. The goal is to minimize these with the shorter treatment.
PR07 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer has a low to intermediate Gleason score.
PR07 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years after completion of radiation therapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years after completion of radiation therapy
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cumulative incidence of treatment-related grade 2 or higher rectal bleeding.
Secondary outcome measures
Analysis of disease control
Analysis of overall survival
Analysis of treatment-related morbidity
+1 morePR07 Trial Design
2Treatment groups
Experimental Treatment
Group I: Low RiskExperimental Treatment1 Intervention
70 Gy/CGE
Group II: Intermediate RiskExperimental Treatment1 Intervention
72.5 Gy/CGE
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Who is running the clinical trial?
University of FloridaLead Sponsor
1,340 Previous Clinical Trials
715,335 Total Patients Enrolled
9 Trials studying Prostate Cancer
3,457 Patients Enrolled for Prostate Cancer
Randal H. Henderson, MD, MBAPrincipal InvestigatorUniversity of Florida Proton Therapy Institute
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have prostate cancer.I have had surgery in my pelvic area before.I have had surgery or radiation for prostate cancer.I am taking Saw Palmetto or methotrexate and cannot or do not want to stop during radiation.My prostate cancer has a low to intermediate Gleason score.I have an active inflammatory bowel disease like Crohn's, diverticulitis, or ulcerative colitis.I am currently on a blood thinner like Warfarin, Plavix, Pradaxa, Lovenox, or Aggrenox.I have received chemotherapy for prostate cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Low Risk
- Group 2: Intermediate Risk
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment process currently open for this experiment?
"Clinical trials.gov confirms that this medical trial is not accepting new participants, having been last updated on March 14th 2022 after its initial posting in September 2011. Nevertheless, 1322 other clinical studies are presently admitting patients into the program."
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