Actively Recruiting

Phase 2
Age: 18Years +
MALE
NCT05169970

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

Age: 18Years +
MALE

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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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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