Two Fraction Prostate SBRT With DIL SIB

Last updated: March 3, 2025
Sponsor: NYU Langone Health
Overall Status: Active - Recruiting

Phase

1

Condition

Prostate Cancer, Early, Recurrent

Urologic Cancer

Prostate Cancer

Treatment

Two-Fraction Stereotactic Body Radiation Therapy (SBRT)

Clinical Study ID

NCT05864196
22-01306
  • Ages > 18
  • Male

Study Summary

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.

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

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: Two-Fraction Stereotactic Body Radiation Therapy (SBRT)
Phase: 1
Study Start date:
July 17, 2023
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • NYU Langone Hospital - Long Island

    Mineola, New York 11501
    United States

    Active - Recruiting

  • NYCyberKnife at Perlmutter Cancer Center

    New York, New York 10016
    United States

    Active - Recruiting

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