Actively Recruiting
A Study of Stereotactic Body Radiation Therapy (SBRT) Without Androgen Deprivation Therapy (ADT) in People With Unfavorable Intermediate-Risk Prostate Cancer
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-13
215
Participants Needed
7
Research Sites
259 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The researchers are doing this study to find out if stereotactic body radiation therapy (SBRT) without androgen deprivation therapy (ADT) is an effective treatment approach for people with unfavorable intermediate-risk prostate. The researchers will see whether SBRT can prevent participants' cancer from coming back and/or spreading to other parts of the body. In addition, they will look closely at how safe and effective it is to rely on Decipher test results for determining which patients would benefit from more extensive radiation treatments
CONDITIONS
Official Title
A Study of Stereotactic Body Radiation Therapy (SBRT) Without Androgen Deprivation Therapy (ADT) in People With Unfavorable Intermediate-Risk Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically proven prostate adenocarcinoma diagnosis within 12 months of enrollment
- Unfavorable intermediate-risk prostate cancer by NCCN 2021 guidelines, including any of: Gleason Score 4+3, 50% biopsy cores positive, or two or more of Grade Group 2 or 3, cT2b-T2c, PSA 10-20 ng/mL
- Able to undergo MRI for initial staging and radiation planning
- Sufficient biopsy tissue available for Decipher genomic testing
- Prostate volume less than 90cc
- IPSS score 20 or less
- Age 18 years or older
- Karnofsky Performance Status (KPS) or ECOG 0-2
- Estimated life expectancy greater than 5 years
- Willing and able to provide written informed consent and HIPAA authorization
You will not qualify if you...
- Radiographic T3-T4 disease detected on staging mpMRI with high probability
- Evidence of distant metastases by MRI, PET, or CT
- Evidence of pelvic lymph node involvement by MRI, PET, or CT
- Prior treatment for prostate cancer including chemotherapy, surgery, or hormonal therapy
- Prior pelvic radiation
- Active second malignancy or cancer history within last 2 years requiring active therapy or in remission, except certain early-stage cancers
- TURP or greenlight PVP procedure within 6 months prior to enrollment
- History of Crohn's Disease or Ulcerative Colitis
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
D
Daniel Gorovets, MD
CONTACT
M
Marisa Kollmeier, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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