NCT05864196 · NYU Langone Health
Two Fraction Prostate SBRT With DIL SIB
What this study is about
Phase I/Ib, single treatment group$1 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.
View original scientific 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.
Interventions
RADIATION
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 measures
Number of Grade 2 or Higher Toxicities per CTCAE version 5.0
Time frame: Up 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Mineola, New York
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 29, 2026 · Source of record for eligibility and locations