Two Fraction Prostate SBRT With DIL SIB

Description

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

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Study Overview

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Study Details

Study overview

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.

A Phase I/Ib, Single Arm Study of Two Fraction Stereotactic Body Radiation Therapy (SBRT) With Dominant Lesion Simultaneous Integrated Boost (SIB) for the Treatment of Low to Intermediate Risk Prostate Cancer

Two Fraction Prostate SBRT With DIL SIB

Condition
Prostate Cancer
Intervention / Treatment

-

Contacts and Locations

Mineola

NYU Langone Hospital - Long Island, Mineola, New York, United States, 11501

New York

NYCyberKnife at Perlmutter Cancer Center, New York, New York, United States, 10016

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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
  • * 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

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

NYU Langone Health,

Jonathan Lischalk, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

2026-06