Fact CheckerSign in

NCT05169970Active, not recruitingPhase 2

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

A Phase II Study of Decipher-Guided Dose Escalated Radiation Therapy In Unfavorable Intermediate Risk Prostate Cancer Patients Treated SBRT Alone Without Androgen Deprivation Therapy

Source: ClinicalTrials.gov · Last updated 14 Jul 2026

Brief summary (registry, in English)

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

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
222 (actual)
First submitted
9 Dec 2021
Start date
9 Dec 2021
Primary completion date
Dec 2027
Lead sponsor
Memorial Sloan Kettering Cancer Center
NCT number
NCT05169970

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 222
  • From 9 Dec 2021 to the primary completion date, Dec 2027
  • 7 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior treatment for prostate cancer including chemotherapy, surgery, or hormonal therapy
  • Prior pelvic radiation

Other illness

  • Radiographic T3-T4 detected on staging mpMRI
    • °Must be "consistent with" (\>90% probability) or suspicious for/probable/probably (75%-90% probability) ofT3-T4 disease determined by the reading radiologist.
  • 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
  • History of Crohn's Disease or Ulcerative Colitis

Other

  • 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
  • TURP or greenlight PVP within 6 months of enrollment

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Coordinator of this site? Confirm its status
Basking RidgeUnited StatesUnknown status
Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
Coordinator of this site? Confirm its status
CommackUnited StatesUnknown status
Memorial Sloan Kettering Westchester (All Protocol Activities)
Coordinator of this site? Confirm its status
HarrisonUnited StatesUnknown status
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Coordinator of this site? Confirm its status
MiddletownUnited StatesUnknown status
Memorial Sloan Kettering Bergen (All Protocol Activities)
Coordinator of this site? Confirm its status
MontvaleUnited StatesUnknown status
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Memorial Sloan Kettering Nassau (All Protocol Activities)
Coordinator of this site? Confirm its status
UniondaleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.