ADT and SBRT vs SBRT Alone for Unfavorable Intermediate Risk Prostate Cancer

This study is for men with unfavorable intermediate risk prostate cancer. It compares two treatments: standard hormone therapy (Androgen Deprivation Therapy or ADT, using Leuprolide, Degarelix, or Relugolix) combined with a type of radiation called Stereotactic Body Radiation Therapy (SBRT), versus SBRT alone. The goal is to see which approach is better at preventing the cancer from returning (Disease-Free Survival) over five years. To join, you must have prostate cancer that fits specific criteria, including certain Gleason scores or PSA levels, and tissue available for a Decipher score test. The current recruitment status is unclear.

Study design: This interventional study plans to enroll 392 participants. Patients will choose between receiving ADT plus SBRT or SBRT alone.
What's involved: You will be followed every 6 months for up to 5 years. You will also have a prostate biopsy 24-30 months after SBRT.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed for up to 5 years after the first treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

ADT and SBRT vs SBRT Alone for Unfavorable Intermediate Risk Prostate Cancer

Recruiting

PHASE2Ages 18+InterventionalTreatment

NYU Langone Health

~392 participants

Updated 2026-01-28 on ClinicalTrials.gov

What's tested:Leuprolide, Degarelix or RelugolixStereotactic body radiation therapy/radiosurgery (SBRT)

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Disease-Free Survival

Measured over Up to Year 5

Conditions

Prostate Cancer

Where it's being run

1 sites across 1 states

New York1

Study leadership

Michael Zelefsky · PRINCIPAL_INVESTIGATOR · NYU Langone Health

Who to contact

Dayna Leis, RN

[email protected]

347-266-2630

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Biopsy proven unfavorable intermediate risk prostate cancer, which includes patients with any one of the following variables: Gleason 4+3 disease; Percent positive cores \> 50% of Gleason 7 disease; 2-3 intermediate risk factors (Gleason 7; PSA 10-20 ng/mL; or T2b-T2c)

Patients must have tissue available for Decipher score testing. Results must be available before start of treatment.

Serum testosterone ≥ 150 ng/dL determined within 2 months prior to enrollment

At least 4 weeks must have elapsed from major surgery

Karnofsky Performance Scale (KPS) ≥ 80%

Prostate size as determined on MRI to be \< 90 cc. Prostate size can be determined on CT scan if MRI is not available

IPSS ≤ 20

Patient must be available for follow-up. After 2 years of follow-up, upon completion of post-treatment biopsy, telephone and chart review-based follow-up will be acceptable

Adequate hepatic function with serum bilirubin less than or equal to 1.5 times the upper institutional limits of normal (ULN), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) less than or equal to 2.5 x ULN. Patients with a history of Gilbert's syndrome may be enrolled if the total bilirubin is \< 3 mg/dL with a predominance of indirect bilirubin

Adequate renal function with serum creatinine less than or equal to 1.5 x ULN

Adequate hematologic function with absolute neutrophil counts of at least 1,500 cell/mm3 and platelets of at least 100,000 cells/mm3 and hemoglobin value \> 9 g/dL (Note: patients whose anemia has been corrected to a hemoglobin value \> 9 g/dL with blood transfusions are allowed).

Exclusion

CT or MRI or Positron Emission Tomography (PET) scan evidence of metastatic disease to the bone

Patients with one or more positive lymph nodes considered suspicious as determined by clinical assessment on MRI or CT or PET scan

Prior treatment for prostate cancer, including history of chemotherapy, hormonal therapy within 30 days of enrollment or surgery for prostate cancer (except for prior (transurethral resection of prostate) TURP or greenlight (photoselective vaporization of prostate) PVP which would be allowed)

History of another malignancy within the previous 2 years except for the following: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, currently in complete remission, or any other cancer that has been in complete remission for at least 3 years

Patients with Crohn's disease or ulcerative colitis

What this trial measures

Disease-Free SurvivalUp to Year 5
Defined as the percentage of participants who survive without any signs or symptoms of prostate cancer.

Trialytics