Hypofractionated Radiation Therapy for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Overseen byDanny Song, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?This will be a Phase II study evaluating the effectiveness and toxicity of a specific radiation therapy regimen. This choice of daily dose is based on the prior published experience showing safety and efficacy of hypofractionated regimens. The total dose is calculated to be effective for late effects which has been shown to be effective and safe in a large prospective Phase II study. If the hypothesis for the prostate is is true, then this regimen should be at least as effective or more effective for tumor control than the current conventional therapy.

Eligibility Criteria

Men with early-stage prostate cancer (Gleason score <7, PSA <10 ng/ml, stages T1a-T2b) who have chosen external beam radiation as their treatment can join. They must sign a consent form. Men with advanced cancer, high Gleason scores or PSA levels, previous major treatments for prostate cancer, other recent cancers (except certain skin/bladder cancers), inflammatory bowel disease, or serious medical/psychiatric issues cannot participate.

Inclusion Criteria

My prostate cancer is in an early stage and my PSA level is below 10 ng/ml.

My prostate cancer has a low Gleason score.

I have chosen external beam radiation to treat my prostate cancer.

+2 more

Exclusion Criteria

My prostate cancer has a Gleason score of 7 or higher.

I have had chemotherapy or radiation therapy to the pelvis before.

I have a history of inflammatory bowel disease.

+7 more

Participant Groups

The trial is testing a specific type of radiation therapy called hypofractionation to see if it's effective and safe in treating localized adenocarcinoma of the prostate. This Phase II study builds on earlier research suggesting that this approach could control tumors better than conventional therapy.

1Treatment groups

Experimental Treatment

Group I: Hypofractionated radiation therapy in prostate adenocarcinomaExperimental Treatment1 Intervention

Participants with histologically confirmed, locally confined adenocarcinoma of the prostate receive 3.6 Gy per day to a total dose of 57.6 Gy (16 fractions).

Hypofractionation is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Hypofractionation for: