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Radiation Therapy Approaches for People With Prostate Cancer

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07751159
Enrollment
126
Registered
2026-08-07
Start date
2026-07-31
Completion date
2030-07-31
Last updated
2026-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Risk Prostate Cancer, Non-metastatic Prostate Cancer, Prostate Cancer Patients

Keywords

prostate cancer, Non-metastatic prostate cancer, intermediate prostate cancer, high risk prostate cancer, very high risk prostate cancer, Memorial Sloan Kettering Cancer Center, 26-288

Brief summary

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

Interventions

RADIATIONStandard of Care HDR Brachytherapy

HDR Brachytherapy

RADIATIONSBRT

SBRT alone

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER
Palette Life Sciences, Inc.
CollaboratorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in International Prostate Symptom Score / IPSS at 3 months3 monthsChange 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

Countries

United States

Contacts

CONTACTDaniel Gorovets, MD
gorovetd@mskcc.org212-639-3983
CONTACTHimanshu Nagar, MD
nagarh1@mskcc.org212-639-6478
PRINCIPAL_INVESTIGATORDaniel Gorovets, MD

Memorial Sloan Kettering Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 13, 2026