Radiation therapy options for high-risk prostate cancer
Official title: Balancing Radiation Intensification and Quality of Life in Higher-Risk Prostate Cancer (The BALANCE-RT Trial)
Run by Memorial Sloan Kettering Cancer Center · NCT07751159 · Data updated 2026-11-12
This trial tests different ways of giving radiation therapy to see which balance best controls the cancer with the fewest side effects in men with high-risk, non-metastatic prostate cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Sex | All |
| Enrollment | 126 (estimated) |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Status | Recruiting |
| Started | July 31, 2026 |
| Main results expected | July 31, 2030 |
| Study ends | July 31, 2030 |
| Registry record updated | August 12, 2026 |
| Trial ID | NCT07751159 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Men with non-metastatic prostate cancer classified as unfavorable intermediate, high, or very high risk by NCCN guidelines who are suitable for both HDR brachytherapy boost and SBRT.
✕Probably not a fit
Patients with disease characteristics or comorbidities that make one radiation approach unsuitable may not benefit from the tested strategies.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2 interventional trial compares standard of care radiation approaches, including HDR brachytherapy boost and SBRT, to determine effective strategies for tumor control while minimizing treatment-related toxicity in men with unfavorable intermediate to very high-risk, non-metastatic prostate cancer. Eligibility includes NCCN-classified high- or very high-risk disease, with eligibility potentially including MRI or PSMA PET findings. Participants are treated at Memorial Sloan Kimmel Cancer Center facilities in New Jersey, with limited protocol activities at select satellite sites. The study is sponsored by Memorial Sloan Kig Institute and collaborates with Palette Life Sciences, Inc.
Why it matters
Potential benefit: Participants may receive a treatment approach that provides good cancer control while reducing side effects compared with other radiation schedules.
How similar studies have gone: Prior studies in prostate cancer have explored HDR brachytherapy and SBRT separately, showing promise; this trial builds on that work to optimize combined approaches, with mixed generalizability pending results.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States Recruiting -
Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States Recruiting -
Memorial Sloan Kettering at Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States Recruiting -
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
Commack, New York, United States Recruiting -
Memorial Sloan Kettering at Westchester (Limited Protocol Activities)
Harrison, New York, United States Recruiting -
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York, United States Recruiting
Show 1 more location
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Memorial Sloan Kettering at Nassau (Limited Protocol Activities)
Uniondale, New York, United States Recruiting
Study contacts
- Principal investigator: Daniel Gorovets, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Daniel Gorovets, MD
- Email: gorovetd@mskcc.org
- Phone: 212-639-3983
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Repeated PSMA PET scans to monitor treatment response in clinically significant prostate cancer.
This project will test whether doing a PSMA PET/CT before treatment and again after treatment (or at early PSA rise) helps track response in people with newly diagnosed clinically significant (Gleason ≥7) prostate cancer.
-
Androgen-guided PSMA-PET-boost for prostate cancer treated with ADT and SBRT
This study tests whether using PSMA-PET imaging during hormone therapy can help doctors target remaining cancer with a focused SBRT boost in men with intermediate- or high-risk prostate cancer.
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Delayed pelvic [68Ga]-PSMA PET/CT using the first CT for men with high-risk prostate cancer
This test tries to see if doing a delayed pelvic [68Ga]-PSMA PET that reuses the initial CT (so no second CT) keeps image quality while lowering radiation for men with high‑risk or recurrent prostate cancer.
-
Post-treatment care program for breast and prostate cancer survivors
This program tests whether a focused questionnaire plus quality-of-life screening can detect and help manage side effects in people who have finished curative treatment for breast or prostate cancer.
-
Tb-PSMA radionuclide treatment before radical prostatectomy for locally advanced prostate cancer
This will try giving a Tb-PSMA radionuclide treatment to men with high-risk, locally advanced prostate cancer before prostate removal to see if it is safe and reduces tumor burden.
-
Adaptive stereotactic body radiotherapy with pelvic treatment and focal dose boost for high-risk prostate cancer
This trial will try an adaptive form of focused high-dose radiation to the prostate and pelvic lymph nodes, with an extra dose to the main tumor area, for men with high-risk prostate cancer to see if it improves outcomes and cost-effectiveness compared with standard radiotherapy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.