RecruitingPhase 2NCT04465500

EBRT and HDR Brachytherapy for Unfavorable-intermediate, High, and Very High-risk Prostate Cancer

Prospective Trial of Combination External Beam Radiation Therapy and MRI-guided, Dose-differentiated High Dose-rate Prostate Brachytherapy Boost for Unfavorable-intermediate, High, and Very High-risk Prostate Cancer


Sponsor

University of Virginia

Enrollment

60 participants

Start Date

Jul 30, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This study is trying to find out if the combination of Androgen deprivation therapy (ADT), MRI guided high dose radiation (HDR) brachytherapy treatment (internal radiation implant procedure) and external beam radiation therapy (EBRT) treatments lead to less side effects. This study is also looking at patient outcomes, quality of life, and overall survival for patients receiving this treatment.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at the outcomes of combining external beam radiation therapy (a standard radiation approach) with high-dose-rate brachytherapy (placing radioactive seeds directly inside the prostate) for men with intermediate or high-risk prostate cancer. Researchers want to see how well this combined approach works and what side effects patients experience. **You may be eligible if:** - You are a man aged 18 or older - You have a confirmed prostate cancer diagnosis within the last year - Your prostate cancer is classified as unfavorable-intermediate, high, or very high risk (by NCCN guidelines) - Your PSA level was below 50 ng/mL before any hormone therapy - You are in good general health (ECOG 0 or 1) - You have had a pelvic MRI within the past 12 months **You may NOT be eligible if:** - Your cancer has spread to the bones - You have had a previous prostate removal surgery or prostate cryosurgery - You have had previous pelvic radiation or prostate seed implants - You have another active cancer (other than minor skin cancers), unless you have been cancer-free for at least 3 years 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

RADIATIONExternal Beam Radiation

EBRT will be administered every 5 consecutive days for 5 consecutive weeks. This is standard of care practice for this therapy. This may be revised as applicable per treating physician discretion. The dose of radiation will be in accordance with standard clinical practice guidelines for the treatment of prostate cancer.

RADIATIONHDR Brachytherapy

HDR brachytherapy will be administered per standard clinical practice (per NCCN guidelines version 1.2020 for prostate cancer), however standard clinical practice may vary between clinicians. Therefore, the dose of 15Gy in 1 fraction and a set of dosimetry guidelines are to be followed for the purposes of this study. A diagnostic MRI will be co-registered with Transrectal Ultrasound (TRUS) to perform the HDR brachytherapy.

DRUGAndrogen Deprivation Therapy

The dosing and administration of ADT will be in accordance with the drug label for the drug(s) used for this purpose. Participants may receive ADT before and/or during the course of this study.


Locations(1)

University of Virginia

Charlottesville, Virginia, United States

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NCT04465500


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