Recruiting

NCT Number: NCT07751159

Radiation Therapy Approaches for People With Prostate Cancer

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

Recruiting

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Key information

Conditions

Prostate Cancer Patients Genital Diseases Genital Diseases, Male Genital Neoplasms, Male High Risk Prostate Cancer Male Urogenital Diseases Neoplasms Neoplasms by Site Non-Metastatic Prostate Cancer Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 (see clinical considerations for treatment eligibility below)

Exclusion criteria

None

Treatment and study plan

Brachytherapy

Radiation

Standard of care Brachytherapy

SBRT

Drug

SBRT alone

Primary outcomes

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

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Gorovets, MD

CONTACT

[email protected]

212-639-3983

Himanshu Nagar, MD

CONTACT

[email protected]

212-639-6478

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

Palette Life Sciences, Inc.

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2030
Study completion: 2030
First posted: Aug 7, 2026
Registry last updated: Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting