Prostate Cancer PatientsPhase 2NCT07751159
Radiation Therapy Approaches for People With Prostate Cancer
A Phase 2 study testing SBRT in people with Prostate Cancer Patients and Non-metastatic Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
The purpose of the study is to explore the best ways of giving radiation therapy to balance cancer control and treatment side effects. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Prostate Cancer Patients, Non-metastatic Prostate Cancer, High Risk Prostate Cancer
- What is being tested?
- SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 7 sitesUnited States
- Study dates
- 31 Jul 2026to 31 Jul 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Daniel Gorovets, MD, 212-639-3983
- Recruiting
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
Commack, New York, 11725
Daniel Gorovets, MD, 212-639-3983
- Recruiting
Memorial Sloan Kettering at Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Daniel Gorovets, MD, 212-639-3983
- Recruiting
Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Daniel Gorovets, MD, 212-639-3983
- Recruiting
Memorial Sloan Kettering at Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Daniel Gorovets, MD, 212-639-3983
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York, 10065
Daniel Gorovets, MD, 212-639-3983
- Recruiting
Memorial Sloan Kettering at Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
Daniel Gorovets, MD, 212-639-3983
About this study
Official title: 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.
- Being tested
- Standard of Care HDR Brachytherapy, SBRT
- 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
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care HDR BrachytherapyRadiation
HDR Brachytherapy
SBRTRadiation
SBRT alone
| Study group | Role | What they receive |
|---|---|---|
| Arm A: HDR Brachytherapy Boost + SBRT | Active comparator | Standard of Care Brachytherapy/Radiation and SBRT Receives: Radiation: Standard of Care HDR Brachytherapy; Radiation: SBRT |
| Arm B: SBRT Alone | Experimental | SBRT alone Receives: Radiation: SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in International Prostate Symptom Score / IPSS at 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start31 Jul 2026
- Primary completion31 Jul 2030 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer PatientsStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Palette Life Sciences, Inc.
- Responsible party
- Sponsor
- Investigators
- Daniel Gorovets, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07751159
- Sponsor's protocol ID
- 26-288
- Status last verified
- Aug 2026
- First submitted
- 31 Jul 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: • 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balancing Radiation Intensification and Quality of Life in Higher-Risk Prostate Cancer (The BALANCE-RT Trial)
- ClinicalTrials.gov ID
- NCT07751159
- Acronym / sponsor ID
- 26-288
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Palette Life Sciences, Inc.
- Study start
- 31 Jul 2026 (actual)
- Primary completion
- 31 Jul 2030 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to explore the best ways of giving radiation therapy to balance cancer control and treatment side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: HDR Brachytherapy Boost + SBRT | Active comparator | Radiation: Standard of Care HDR Brachytherapy, Radiation: SBRTStandard of Care Brachytherapy/Radiation and SBRT |
| Arm B: SBRT Alone | Experimental | Radiation: SBRTSBRT alone |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of Care HDR BrachytherapyHDR Brachytherapy | Radiation | Arm A: HDR Brachytherapy Boost + SBRT |
| SBRTSBRT alone | Radiation | Arm A: HDR Brachytherapy Boost + SBRT, Arm B: SBRT Alone |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. • 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel Gorovets, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SBRT in people with Prostate Cancer Patients and Non-metastatic Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Gorovets, MD (212-639-3983, gorovetd@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in International Prostate Symptom Score / IPSS at 3 months (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.