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Two-fraction HDR Monotherapy for Localized Prostate Cancer

NCT05665738 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2025-04-29

No results posted yet for this study

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.

Conditions

  • Prostate Adenocarcinoma
  • Localized Prostate Carcinoma

Interventions

RADIATION

High Dose Rate Monotherapy

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

Sponsors & Collaborators

Principal Investigators

  • I-Chow Hsu, MD · University of California, San Francisco

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-11
Primary Completion
2029-02-28
Completion
2029-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05665738 on ClinicalTrials.gov