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Proton Beam Therapy

Short-Course Proton Radiation for Prostate Cancer

Phase 3

Waitlist Available

Research Sponsored by Proton Collaborative Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No pelvic lymph nodes > 1.5 cm in greatest dimension unless the enlarged lymph node is biopsied and negative

Clinical stages T1a-T2a N0 M0 (AJCC Criteria 7th Ed.). Staging must be done by treating investigator

Must not have

Active rectal diverticulitis, Crohn's disease affecting the rectum, or ulcerative colitis

Prior systemic chemotherapy for prostate cancer

Timeline

Screening 3 days

Treatment 3 days

Follow Up 3 days

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a more intense but shorter course of radiation therapy for prostate cancer patients to see if it is as effective as the current standard.

Who is the study for?

Men over 18 with low-risk prostate cancer, confirmed within the last year, can join. They should be in good physical shape (able to walk and care for themselves), have a Gleason score of 2-6, PSA under 10 ng/ml, and no history of certain prostate treatments or pelvic radiation. No major health issues that could affect participation are allowed.

What is being tested?

This study tests two ways of giving proton radiation therapy for prostate cancer: the standard way with 44 treatments over about 9 weeks versus a higher daily dose given in just 5 treatments over one to two weeks. The goal is to see if the shorter treatment works as well or better.

What are the potential side effects?

Proton radiation may cause side effects like skin redness, fatigue, frequent urination with discomfort or difficulty during treatment period. Long-term side effects might include changes in bowel habits and sexual function.

Eligibility Criteria

Inclusion Criteria

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

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My pelvic lymph nodes are not enlarged over 1.5 cm, or if they are, they've been tested and are not cancerous.

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My breast cancer is in an early stage and has not spread to lymph nodes or other parts of the body.

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My prostate cancer has a low Gleason score (2-6) based on biopsy.

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I am 18 years old or older.

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I can start treatment within 56 days of being chosen for the trial.

Exclusion Criteria

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

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I have active inflammation or infection in my rectum due to diverticulitis, Crohn's disease, or ulcerative colitis.

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I have received chemotherapy for prostate cancer before.

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I have had surgery for prostate cancer, including removal, heating, or freezing of the prostate.

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I have had a blockage in my urethra that needed stretching.

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I have had radiation therapy for prostate cancer in the pelvic area.

Timeline

Screening ~ 3 days1 visit

Treatment ~ 3 days1 visit

Follow Up ~ 3 days1 visit

Screening ~ 3 days

Treatment ~ 3 days

Follow Up ~3 days

This trial's timeline: 3 days for screening, 3 days for treatment, and 3 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To assess if hypo-fractionation will result in 2-year freedom from failure (FFF) that is non-inferior to 2-year FFF following standard fractionation. FFF will be measured by recurrence, metastasis, PSA or start of salvage therapy.

Secondary study objectives

To determine the incidence of grade 2 or greater GU and GI toxicity in each of the regimens.