NCT05864196 Two Fraction Prostate SBRT With DIL SIB
| NCT ID | NCT05864196 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | NYU Langone Health |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2023-07-17 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 80 participants in total. It began in 2023-07-17 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Jonathan Lischalk
PRINCIPAL INVESTIGATOR
NYU Langone Health
Frequently Asked Questions
Who can join the NCT05864196 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05864196 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05864196 currently recruiting?
Yes, NCT05864196 is actively recruiting participants. Contact the research team at Vianca.santos@nyulangone.org for enrollment information.
Where is the NCT05864196 trial being conducted?
This trial is being conducted at Mineola, United States, New York, United States.
Who is sponsoring the NCT05864196 clinical trial?
NCT05864196 is sponsored by NYU Langone Health. The principal investigator is Jonathan Lischalk at NYU Langone Health. The trial plans to enroll 80 participants.
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