A Study of Stereotactic Body Radiation Therapy (SBRT) Without Androgen Deprivation Therapy (ADT) in People With Unfavorable Intermediate-Risk Prostate Cancer
NCT ID: NCT05169970
Last Updated: 2025-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
215 participants
INTERVENTIONAL
2021-12-09
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Shorter Course Hormone Therapy and Radiation for High-risk Prostate Cancer
NCT05100472
Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Prostate Cancer
NCT04599686
ADT and SBRT vs SBRT Alone for Unfavorable Intermediate Risk Prostate Cancer
NCT06397703
Stereotactic Body Radiotherapy (SBRT) for Localized Prostate Cancer
NCT04489745
Intermittent Androgen Deprivation Therapy With or Without Stereotactic Body Radiotherapy for Molecularly Identified Hormone Sensitive Oligometastatic Prostate Cancer
NCT04619069
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients with low-intermediate risk Decipher scores
Will receive ultrahypofractionated EBRT to the prostate and seminal vesicles (40Gy in 5 fractions).
Stereotactic Body Radiation Therapy (SBRT)
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 high risk Decipher scores
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).
Stereotactic Body Radiation Therapy (SBRT)
Patients with high risk Decipher scores will receive radiation targeting the prostate and seminal vesicles to a dose of 40 Gy in 5 fractions with a simultaneous integrated boost to 45 Gy of any dominant intraprostatic lesion as well as radiation to the pelvic lymph nodes to a dose of 25 Gy in 5 fractions delivered every other day.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Stereotactic Body Radiation Therapy (SBRT)
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.
Stereotactic Body Radiation Therapy (SBRT)
Patients with high risk Decipher scores will receive radiation targeting the prostate and seminal vesicles to a dose of 40 Gy in 5 fractions with a simultaneous integrated boost to 45 Gy of any dominant intraprostatic lesion as well as radiation to the pelvic lymph nodes to a dose of 25 Gy in 5 fractions delivered every other day.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 Criteria
°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
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Daniel Gorovets, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, United States
Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
Commack, New York, United States
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Marisa Kollmeier, MD
Role: CONTACT
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Daniel Gorovets, MD
Role: primary
Daniel Gorovets, MD
Role: primary
Daniel Gorovets, MD
Role: primary
Daniel Gorovets, MD
Role: primary
Daniel Gorovets, MD
Role: primary
Daniel Gorovets, MD
Role: primary
Daniel Gorovets, MD
Role: primary
Related Links
Access external resources that provide additional context or updates about the study.
Memorial Sloan Kettering Cancer Center
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
21-458
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.