Recruiting
Phase 1

SBRT with DIL

Sponsor:

NYU Langone Health

Code:

NCT05864196

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Two-Fraction Stereotactic Body Radiation Therapy (SBRT)

Study Details

Brief 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.

Conditions

Prostate Cancer

Study ID

NCT05864196

Start date

Jul 17, 2023

Status verified date

Jan, 2026

Completion date

Jun, 2030

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Men with low to intermediate risk prostate cancer

Once a patient is deemed eligible, they will be scheduled for treatment with SBRT, which should be completed within 14 days of screening. Follow up will occur 30 days post radiation and every 4 months, post- radiation for the first 2 years. After the first 2 years of follow up, visits will occur every 6 months until year 5.

Interventions

Two-Fraction Stereotactic Body Radiation Therapy (SBRT)

Two-fraction SBRT with an MRI directed, dominant intraprostatic lesion, simultaneous integrated boost (SIB) based on genomic classification in the treatment of localized prostate cancer.

Primary outcome measure

  • Number of Grade 2 or Higher Toxicities per CTCAE version 5.0 [ Time Frame: Up to year 5 Post-Treatment ]

Central Contacts and Locations

Central contacts

Vianca Santos, MPH

212-496-5845Vianca.santos@nyulangone.org

Locations

NYU Langone Hospital - Long Island

Recruiting

Mineola, New York, United States, 11501

NYCyberKnife at Perlmutter Cancer Center

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Jan 29, 2026

Last verified

Jan, 2026

Keywords

  • Prostate Cancer,SBRT,Radiation Treatment,CyberKnife
  • SBRT
  • Radiation Treatment
  • CyberKnife

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-01-29.