Comparison of High-Dose Rate Brachytherapy and Stereotactic Ablative Radiotherapy as Monotherapy for the Treatment of Localized Prostate Cancer
NCT04253483 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14
Last updated 2025-09-17
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.
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
- 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
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Rutgers, The State University of New Jersey
lead OTHER
Principal Investigators
-
Lara Hathout · Rutgers Cancer Institute of New Jersey
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-07-17
- Primary Completion
- 2026-09-01
- Completion
- 2027-09-01
- FDA Device
- Yes
Countries
- United States
Study Locations
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