NCT04465500

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Virginia · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer
• Prostate Adenocarcinoma

Interventions

Type	Name	Description
RADIATION	External 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.
RADIATION	HDR 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.
DRUG	Androgen 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.

Timeline

• Start date: 2020-07-30
• Primary completion: 2027-01-01
• Completion: 2029-01-01
• First posted: 2020-07-10
• Last updated: 2024-05-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study