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

No results posted yet for this study

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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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 NCT04253483 on ClinicalTrials.gov