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

NCT05169970 | Recruiting Phase 2

• 1 other identifier: 21-458
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 7

Brief Summary

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

Prostate Cancer

Keywords

Unfavorable Intermediate-Risk Prostate Cancer; Stereotactic Body Radiation Therapy (SBRT); 21-458

Outcome Measures

Primary Outcomes (1)

• Rate of biochemical progression free survival

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

  2 years

Study Arms (2)

Patients with low-intermediate risk Decipher scores

EXPERIMENTAL

Will receive ultrahypofractionated EBRT to the prostate and seminal vesicles (40Gy in 5 fractions).

Radiation: Stereotactic Body Radiation Therapy (SBRT)

Patients with high risk Decipher scores

EXPERIMENTAL

Will receive ultrahypofractionated EBRT to the prostate and seminal vesicles (40Gy in 5 fractions) with a boost of up to 45Gy to the dominant intraprostatic lesion as identified on pretreatment MRI plus hypofractionated pelvic EBRT (25Gy in 5 fractions).

Radiation: Stereotactic Body Radiation Therapy (SBRT)

Interventions

Stereotactic Body Radiation Therapy (SBRT) RADIATION

Patients with a low or intermediate risk Decipher score will receive radiation targeting the seminal prostate and seminal vesicles to a dose of 40 Gy in 5 fractions delivered every other day.

Patients with low-intermediate risk Decipher scores

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (All Protocol Activities)

Uniondale, New York, 11553, United States

RECRUITING

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Daniel Gorovets, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Gorovets, MD

CONTACT

212-639-3983; gorovetd@mskcc.org

Marisa Kollmeier, MD

CONTACT

212-639-3952

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a phase II nonrandomized noninferiority trial that aims to evaluate the efficacy of dose escalated radiation therapy in the absence of androgen deprivation therapy for Decipher genomic score stratified NCCN unfavorable intermediate risk prostate cancer.

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: December 27, 2021
• Study Start: December 9, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

US (7)