Two Fraction Prostate SBRT With DIL SIB
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:
🦠 Prostate Cancer
🗓️ Study Start (Actual) 17 July 2023
🗓️ Primary Completion (Estimated) June 2025
✅ Study Completion (Estimated) June 2026
👥 Enrollment (Estimated) 80
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 Mineola, New York, United States
📍 New York, New York, United States

📋 Eligibility Criteria

Description

    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 radiation oncologist
    • * Prostate size less than 60cc defined at time of simulation based on MRI
    • * Patient ability to undergo MRI and documented dominant Prostate Imaging Reporting and Data System (PI-RADS) 3 or higher lesion
    • -- Exception is very low risk, low risk, or favorable intermediate risk with a low to intermediate decipher score in which case an SIB is not utilized
    • * Androgen-deprivation therapy (ADT) is left to the discretion of the treating radiation oncologist
    • * Agreement to use effective contraceptive methods such as condoms and spermicidal foam, intrauterine device, or for their partner to use prescription birth control pills
    • * Ability to give informed consent

    Exclusion Criteria:

    • * High risk disease
    • * Pelvic lymph node involvement
    • * Prophylactic lymph node irradiation requirement as determined by the treating radiation oncologist
    • * Evidence of clinical or radiological 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 \> 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-treatment EPIC questionnaire (\>50 overall summary score for each domain)
    • * Men of reproductive potential may not participate unless they agree to use an effective contraceptive method
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 9 May 2023
  • First Submitted that Met QC Criteria 9 May 2023
  • First Posted 18 May 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 23 April 2024
  • Last Update Posted 25 April 2024
  • Last Verified April 2024