Two-Fraction Stereotactic Body Radiation Therapy for Prostate Cancer
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
This study is testing a new type of radiation therapy for localized prostate cancer to see if it is safe and effective in targeting specific tumors.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | NYU Langone Health Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Mineola, New York and 1 other locations) |
| Trial ID | NCT05864196 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adult males aged 18 and older with localized adenocarcinoma of the prostate classified as low to intermediate risk.
Not a fit: Patients with high-risk prostate cancer or those unable to undergo MRI may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective and safer radiation therapy option for patients with localized prostate cancer.
How similar studies have performed: Other studies have shown promise with similar SBRT approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Mineola, New York and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.