NCT04253483

Comparison of High-Dose Rate Brachytherapy and Stereotactic Ablative Radiotherapy as Monotherapy for the Treatment of Localized Prostate Cancer

A Pilot Study Comparing High-Dose Rate Brachytherapy and Stereotactic Ablative Radiotherapy as Monotherapy in Localized Prostate Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial compares high-dose rate brachytherapy and stereotactic ablative radiotherapy as monotherapy in treating patients with prostate cancer that has not spread to other parts of the body (localized). High-dose rate brachytherapy delivers radiation directly into the prostate within a few minutes by a single radioactive seed through temporarily placed plastic catheters inside the prostate gland. Stereotactic ablative radiotherapy is an external beam radiation method that delivers large doses of radiation to the cancer in a short period of time, usually 5 treatments. This trial aims to find which of these two approaches is better in terms of patient-reported quality of life.

Detailed description

PRIMARY OBJECTIVE: I. To assess feasibility of a pilot non-randomized trial evaluating stereotactic ablative radiotherapy (SABR) and high-dose rate brachytherapy for localized prostate cancer. OUTLINE: Patients elect to participate in arms 1 or 2. ARM I: Patients undergo high-dose rate brachytherapy (HDR). ARM II: Patients undergo SABR every other day for 5 treatments. After completion of study treatment, patients are followed up periodically.

Conditions

• Stage I Prostate Cancer AJCC v8
• Stage II Prostate Cancer AJCC v8
• Stage IIA Prostate Cancer AJCC v8
• Stage IIB Prostate Cancer AJCC v8
• Stage IIC Prostate Cancer AJCC v8

Interventions

Type	Name	Description
RADIATION	High-Dose Rate Brachytherapy	Undergo HDR
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
PROCEDURE	Stereotactic Ablative Radiotherapy	Undergo SABR

Timeline

• Start date: 2019-07-17
• Primary completion: 2026-09-01
• Completion: 2027-09-01
• First posted: 2020-02-05
• Last updated: 2025-09-17

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study