High-Dose Brachytherapy for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Overseen byMark Buyyounouski

Age: Any Age

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Stanford University

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial studies the side effects and how well high-dose brachytherapy works in treating patients with prostate cancer that has not spread to other parts of the body. Brachytherapy is a type of radiation therapy in which radioactive material sealed in needles, seeds, wires, or catheters is placed directly into or near a tumor and may be a better treatment in patients with prostate cancer.

Eligibility Criteria

Men with prostate cancer that hasn't spread, having a PSA level below 150 ng/mL and no bone metastases. They should have an AUA Symptom Index score of 20 or less, Gleason score between 6-10, and clinically negative lymph nodes. Men who've had rectal surgery/fistula, T4 disease, high PSA levels (>=150 ng/mL), prior radical treatments for prostate cancer within three years or severe health issues like recent heart problems are excluded.

Inclusion Criteria

American Urological Association Symptom Index (AUA SI) =< 20

My prostate cancer has a Gleason score between 6 and 10.

My cancer has not spread to my bones, confirmed by a scan.

+4 more

Exclusion Criteria

AUA SI > 20

I have had a rectal fistula.

I have had surgery on my rectum.

+6 more

Participant Groups

The trial is testing high-dose brachytherapy—a type of radiation where radioactive material is placed near the tumor—to see how well it works and what side effects it has in treating localized prostate cancer compared to other treatments.

1Treatment groups

Experimental Treatment

Group I: Treatment (HDR brachytherapy, ADT and LHRH agonist therapy)Experimental Treatment8 Interventions

Patients undergo high-dose-rate brachytherapy over 2 fractions. Patients also receive ADT comprising bicalutamide PO QD. Patients may also receive LHRH agonist therapy comprising leuprolide acetate IM or SC, goserelin acetate SC, triptorelin pamoate IM, or degarelix SC for 4-6 months (intermediate-risk patients receiving ADT) or 6-36 months (high-risk patients) at the discretion of the treating physician.