Actively Recruiting
Two Fraction Prostate SBRT With DIL SIB
Led by NYU Langone Health · Updated on 2026-01-29
80
Participants Needed
2
Research Sites
358 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Phase I/Ib, single arm trial of Two-Fraction Stereotactic Body Radiation Therapy (SBRT) with an MRI directed, dominant intraprostatic lesion (DIL), simultaneous integrated boost (SIB) based on genomic classification in the treatment of localized prostate cancer. The primary purpose of this study is to determine the feasibility and safety of two fraction SBRT in patients with localized prostate cancer.
CONDITIONS
Official Title
Two Fraction Prostate SBRT With DIL SIB
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient age greater than or equal 18
- Localized adenocarcinoma of the prostate
- Biopsy-proven diagnosis of prostate adenocarcinoma
- Low to intermediate risk National Comprehensive Cancer Network (NCCN) disease (TX-T2c-8th addition staging, PSA <20 ng/ml, Grade group 3 or less)
- Proper rectal space replacement as determined by the treating radiation oncologist
- Prostate size less than 60cc at time of simulation based on MRI
- Ability to undergo MRI and documented dominant PI-RADS 3 or higher lesion (exception for certain low risk with low to intermediate decipher score)
- Agreement to use effective contraceptive methods
- Ability to give informed consent
You will not qualify if you...
- High risk disease
- Pelvic lymph node involvement
- Need for prophylactic lymph node irradiation
- Evidence of extracapsular extension or seminal vesicle invasion
- Prior radiation to the pelvis
- Prior malignancies within the last 5 years
- Inability to meet pre-specified 2 fraction DVH constraints
- Prostate size greater than 60cc at treatment planning MRI
- Active significant inflammatory bowel disease or rheumatological disease
- Prior prostate surgeries including uro lift or TURP within 6 months
- "Reasonable" urinary, bowel, and erectile function not met as defined by pre-treatment EPIC questionnaire
- Men of reproductive potential not agreeing to use effective contraception
AI-Screening
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Trial Site Locations
Total: 2 locations
1
NYU Langone Hospital - Long Island
Mineola, New York, United States, 11501
Actively Recruiting
2
NYCyberKnife at Perlmutter Cancer Center
New York, New York, United States, 10016
Actively Recruiting
Research Team
V
Vianca Santos, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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