RecruitingNot ApplicableNCT05665738

Two-fraction HDR Monotherapy for Localized Prostate Cancer

Two-fraction High Dose Rate Brachytherapy as Monotherapy Delivered Three Hours Apart in Localized Prostate Cancer: A Pilot Study


Sponsor

University of California, San Francisco

Enrollment

17 participants

Start Date

Sep 11, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single center single arm prospective pilot study investigating the safety of high dose rate (HDR) brachytherapy as monotherapy delivered in 2 fractions 3 hours apart. HDR monotherapy has been established as safe and effective in this context, however previous studies have delivered 2 fractions on separate days, or at least 6 hours apart. Clinically, this regimen, if shown to be safe and effective in future studies, has the potential to reduce operative resources and logistical stresses on brachytherapy departments.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a two-session high-dose-rate (HDR) brachytherapy approach — a targeted form of internal radiation delivered directly into the prostate — for men with low to intermediate risk prostate cancer. Researchers want to see if just two radiation sessions are as safe and effective as more conventional multi-session approaches. **You may be eligible if...** - You have been diagnosed with prostate adenocarcinoma (prostate cancer) - Your cancer is classified as low to intermediate risk (per NCCN guidelines) - You have not had any prior treatment for prostate cancer - You are 18 or older - You are physically able to undergo the brachytherapy procedure (ECOG/Karnofsky score within acceptable range) - If you have HIV, hepatitis B, or hepatitis C, these must be well-controlled **You may NOT be eligible if...** - You have had any prior prostate cancer treatment or androgen deprivation therapy - You have high-risk or very high-risk prostate cancer - You are not a suitable candidate for brachytherapy as determined by your radiation oncologist Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONHigh Dose Rate Monotherapy

High dose rate brachytherapy delivered in 13.5 Gy x 2 fractions over a single implant procedure 3 hours apart


Locations(1)

University of California, San Francisco

San Francisco, California, United States

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NCT05665738


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