Radiation Therapy Approaches for People With Prostate Cancer

August 10, 2026 updated by: Memorial Sloan Kettering Cancer Center

Balancing Radiation Intensification and Quality of Life in Higher-Risk Prostate Cancer (The BALANCE-RT Trial)

The purpose of the study is to explore the best ways of giving radiation therapy to balance cancer control and treatment side effects.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

126

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
        • Contact:
          • Daniel Gorovets, MD
          • Phone Number: 212-639-3983
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)
        • Contact:
          • Daniel Gorovets, MD
          • Phone Number: 212-639-3983
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering at Bergen (Limited Protocol Activities)
        • Contact:
          • Daniel Gorovets, MD
          • Phone Number: 212-639-3983
    • New York
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
        • Contact:
          • Daniel Gorovets, MD
          • Phone Number: 212-639-3983
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering at Westchester (Limited Protocol Activities)
        • Contact:
          • Daniel Gorovets, MD
          • Phone Number: 212-639-3983
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center (All protocol activites)
        • Contact:
          • Daniel Gorovets, MD
          • Phone Number: 212-639-3983
      • Uniondale, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering at Nassau (Limited Protocol Activities)
        • Contact:
          • Daniel Gorovets, MD
          • Phone Number: 212-639-3983

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Non-metastatic prostate cancer.
  • Classified as unfavorable intermediate-, high-, or very high-risk prostate cancer according to NCCN risk stratification guidelines. (Note: cT3a or T3b by MRI or PSMA PET allowed)
  • Considered by the treating radiation oncologist as a suitable candidate for both HDR brachytherapy boost and SBRT

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm A: HDR Brachytherapy Boost + SBRT
Standard of Care Brachytherapy/Radiation and SBRT
Radiation: Standard of Care HDR Brachytherapy
HDR Brachytherapy
Radiation: SBRT
SBRT alone
Experimental: Arm B: SBRT Alone
SBRT alone
Radiation: SBRT
SBRT alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in International Prostate Symptom Score / IPSS at 3 months
Time Frame: 3 months
Change in International Prostate Symptom Score / IPSS to measure if SBRT alone results in less acute patient reported urinary symptoms measured by IPSS at 3 months than HDR brachytherapy boost combined with SBRT
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Palette Life Sciences, Inc.

Investigators

  • Principal Investigator: Daniel Gorovets, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2026

Primary Completion (Estimated)

July 31, 2030

Study Completion (Estimated)

July 31, 2030

Study Registration Dates

First Submitted

July 31, 2026

First Submitted That Met QC Criteria

August 5, 2026

First Posted (Actual)

August 7, 2026

Study Record Updates

Last Update Posted (Actual)

August 12, 2026

Last Update Submitted That Met QC Criteria

August 10, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26-288

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

• Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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