Two-Fraction Stereotactic Body Radiation Therapy for Prostate Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase I/Ib trial evaluates the feasibility and safety of administering Two-Fraction Stereotactic Body Radiation Therapy (SBRT) with a simultaneous integrated boost (SIB) targeting a dominant intraprostatic lesion in patients with localized prostate cancer. The approach utilizes MRI guidance and genomic classification to tailor treatment. The study aims to assess the effectiveness of this innovative radiation therapy method in a single-arm format.

Why it matters

Who can join: the full rules

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 it's running

• NYU Langone Hospital - Long Island
  Mineola, New York, United States Recruiting
• NYCyberKnife at Perlmutter Cancer Center
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Jonathan Lischalk — NYU Langone Health
• Study coordinator: Vianca Santos, MPH
• Email: Vianca.santos@nyulangone.org
• Phone: 212-496-5845

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.