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

Must not have

Prior intrapelvic surgery

Previous prostate cancer surgery or pelvic radiation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up cumulative incidence up to 20 years after completion of radiation therapy

Awards & highlights

No Placebo-Only Group

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.

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).

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer has a low to intermediate Gleason score.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had surgery in my pelvic area before.

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I have had surgery or radiation for prostate cancer.

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I am taking Saw Palmetto or methotrexate and cannot or do not want to stop during radiation.

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I have an active inflammatory bowel disease like Crohn's, diverticulitis, or ulcerative colitis.

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I am currently on a blood thinner like Warfarin, Plavix, Pradaxa, Lovenox, or Aggrenox.

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I have received chemotherapy for prostate cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ cumulative incidence up to 20 years after completion of radiation therapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~cumulative incidence up to 20 years after completion of radiation therapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and cumulative incidence up to 20 years after completion of radiation therapy for reporting.