NCT05169970

A Study of Stereotactic Body Radiation Therapy (SBRT) Without Androgen Deprivation Therapy (ADT) in People With Unfavorable Intermediate-Risk Prostate Cancer

Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~222 participants
Updated 2026-07-14 on ClinicalTrials.gov
What's tested:Stereotactic Body Radiation Therapy (SBRT)

At a glance

Recruiting sites
0 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of biochemical progression free survival
Measured over 2 years
Prostate Cancer
7 sites across 2 states
New York4
New Jersey3
  • Daniel Gorovets, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

Pathologically proven diagnosis of prostate adenocarcinoma within 12 months of enrollment
Unfavorable intermediate risk prostate cancer by NCCN 2021 risk stratification guidelines, including any of the following clinicopathologic features:
Gleason Score 4+3
≥ 50% biopsy cores positive
Two or more of the following risk factors:
Grade Group 2 or 3
cT2b-T2c
PSA 10 - 20 ng/mL
Able to undergo MRI for initial staging and MR based radiation planning
Sufficient biopsy tissue available for Decipher genomic testing
Prostate volume \< 90cc
IPSS ≤ 20
Age ≥ 18
KPS ≥ or ECOG 0-2
Estimated life expectancy \>5 years
Willing and able to provide written informed consent and Authorization for Use and Release of Health and Research Study Information (HIPAA authorization)

Exclusion

Radiographic T3-T4 detected on staging mpMRI
Evidence of distant metastases as determined by MRI, PET, or CT imaging
Evidence of pelvic lymph node involvement as determined by MRI, PET, or CT imaging
Prior treatment for prostate cancer including chemotherapy, surgery, or hormonal therapy
Prior pelvic radiation
Active second malignancy or past history of malignancies diagnosed within the last 2 years that requires active therapy and/or in remission, with the exception of resected non-melanoma skin cancers, non-muscle invasive bladder cancer, stage I head and neck cancer, or stage I colorectal cancer
TURP or greenlight PVP within 6 months of enrollment
History of Crohn's Disease or Ulcerative Colitis
  • Rate of biochemical progression free survival2 years

    Biochemical progression will be determined according to the established criteria of 2 ng/nl elevation of the PSA nadir level (nadir + 2 definition).