Recruiting
Phase 2

Radiation Therapy

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT07751159

Conditions

Prostate Cancer Patients

Non-metastatic Prostate Cancer

High Risk Prostate Cancer

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Standard of Care HDR Brachytherapy

SBRT

Study Details

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.

Conditions

Prostate Cancer Patients

Non-metastatic Prostate Cancer

High Risk Prostate Cancer

Study ID

NCT07751159

Start date

Jul 31, 2026

Status verified date

Aug, 2026

Completion date

Jul 31, 2030

Anticipated

Primary completion date

Jul 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

126 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arm A: HDR Brachytherapy Boost + SBRT

Standard of Care Brachytherapy/Radiation and SBRT

experimental: Arm B: SBRT Alone

SBRT alone

Interventions

Standard of Care HDR Brachytherapy

HDR Brachytherapy

SBRT

SBRT alone

Primary outcome measure

  • Change in International Prostate Symptom Score / IPSS at 3 months [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Locations

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Daniel Gorovets, MD

212-639-3983

Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Daniel Gorovets, MD

212-639-3983

Memorial Sloan Kettering at Bergen (Limited Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Daniel Gorovets, MD

212-639-3983

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Daniel Gorovets, MD

212-639-3983

Memorial Sloan Kettering at Westchester (Limited Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Daniel Gorovets, MD

212-639-3983

Memorial Sloan Kettering Cancer Center (All Protocol Activites)

Recruiting

New York, New York, United States, 10065

Contacts

Daniel Gorovets, MD

212-639-3983

Memorial Sloan Kettering at Nassau (Limited Protocol Activities)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Daniel Gorovets, MD

212-639-3983

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-08-12.