NCT05864196RecruitingPhase 1

Two Fraction Prostate SBRT With DIL SIB

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

Source: ClinicalTrials.gov · Last updated 29 Jan 2026

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Phase (registry): Phase 1
Study type: Interventional
Enrollment: 80 (estimated)
First submitted: 9 May 2023
Start date: 17 Jul 2023
Primary completion date: Jun 2028
Lead sponsor: NYU Langone Health
Diseases: Prostate cancer
NCT number: NCT05864196

What you commit to

Study type: Interventional · Phase 1
Planned participants: 80
From 17 Jul 2023 to the primary completion date, Jun 2028
2 sites in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Prophylactic lymph node irradiation requirement as determined by the treating radiation oncologist
Prior radiation to the pelvis
Prior prostate surgeries
- Previous uro lift
- Transurethral resection of the prostate (TURP) within 6 months of SBRT

Other illness

High risk disease
Prior malignancies within the last 5 years
Active significant inflammatory bowel disease (IBD) or rheumatological disease

Other

Pelvic lymph node involvement
Evidence of clinical or radiological extracapsular extension or seminal vesicle invasion
Inability to meet pre-specified 2 fraction DVH constraints
Prostate size \> 60cc as measures at treatment planning MRI
"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

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
NYU Langone Hospital - Long Island Coordinator of this site? Confirm its status	Mineola	United States	Recruiting
NYCyberKnife at Perlmutter Cancer Center Coordinator of this site? Confirm its status	New York	United States	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.