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Two-Fraction SBRT for Localized Prostate Cancer

This study is testing a new way to deliver radiation therapy called Two-Fraction Stereotactic Body Radiation Therapy (SBRT) for men with localized prostate cancer. This treatment uses a special MRI-guided technique to give a higher dose of radiation to the main tumor area (dominant intraprostatic lesion, SIB). The main goal is to see how safe and practical this two-fraction SBRT treatment is. You might be able to join if you are at least 18 years old, have been diagnosed with localized prostate adenocarcinoma, and have low to intermediate risk disease according to specific criteria. The researchers will be looking at the number of side effects (toxicities) up to five years after treatment to determine success.

Study design
This is a Phase I/Ib, single-arm study, meaning all 80 participants will receive the same treatment. It aims to evaluate the feasibility and safety of the intervention.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to five years after treatment to monitor for side effects.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05864196

Two Fraction Prostate SBRT With DIL SIB

Recruiting
PHASE1Ages 18+InterventionalTreatment
NYU Langone Health
~80 participants
Updated 2026-01-29 on ClinicalTrials.gov
What's tested:Two-Fraction Stereotactic Body Radiation Therapy (SBRT)

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Grade 2 or Higher Toxicities per CTCAE version 5.0
Measured over Up to year 5 Post-Treatment

Conditions

Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

2 sites across 1 states
New York2

Study leadership

  • Jonathan Lischalk · PRINCIPAL_INVESTIGATOR · NYU Langone Health

Who to contact

Vianca Santos, MPH
[email protected]
212-496-5845
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Number of Grade 2 or Higher Toxicities per CTCAE version 5.0Up to year 5 Post-Treatment

    Number of toxicities determined to be Grade 2 or higher based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.