Phase
Condition
Prostate Cancer, Early, Recurrent
Urologic Cancer
Prostate Cancer
Treatment
Two-Fraction Stereotactic Body Radiation Therapy (SBRT)
Clinical Study ID
Ages > 18 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 required as determined by the treating radiationoncologist
Prostate size less than 60cc defined at time of simulation based on MRI
Patient ability to undergo MRI and documented dominant Prostate Imaging Reportingand Data System (PI-RADS) 3 or higher lesion
-- Exception is very low risk, low risk, or favorable intermediate risk with a lowto intermediate decipher score in which case an SIB is not utilized
Androgen-deprivation therapy (ADT) is left to the discretion of the treatingradiation oncologist
Agreement to use effective contraceptive methods such as condoms and spermicidalfoam, intrauterine device, or for their partner to use prescription birth controlpills
Ability to give informed consent
Exclusion
Exclusion Criteria:
High risk disease
Pelvic lymph node involvement
Prophylactic lymph node irradiation requirement as determined by the treatingradiation oncologist
Evidence of clinical or radiological extracapsular extension or seminal vesicleinvasion
Prior radiation to the pelvis
Prior malignancies within the last 5 years
Inability to meet pre-specified 2 fraction DVH constraints
Prostate size > 60cc as measures at treatment planning MRI
Active significant inflammatory bowel disease (IBD) or rheumatological disease
Prior prostate surgeries
Previous uro lift
Transurethral resection of the prostate (TURP) within 6 months of SBRT
"Reasonable" urinary, bowel, and erectile function as defined by the pre-treatmentEPIC questionnaire (>50 overall summary score for each domain)
Men of reproductive potential may not participate unless they agree to use aneffective contraceptive method
Study Design
Connect with a study center
NYU Langone Hospital - Long Island
Mineola, New York 11501
United StatesActive - Recruiting
NYCyberKnife at Perlmutter Cancer Center
New York, New York 10016
United StatesActive - Recruiting
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