NYU Langone Health
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.
Prostate Cancer
Two-Fraction Stereotactic Body Radiation Therapy (SBRT)
Phase 1
Study Type : | Interventional |
Estimated Enrollment : | 80 participants |
Masking : | None (Open Label) |
Primary Purpose : | Treatment |
Official Title : | 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 |
Actual Study Start Date : | July 17, 2023 |
Estimated Primary Completion Date : | June 2025 |
Estimated Study Completion Date : | June 2026 |
Arm | Intervention/treatment |
---|---|
Experimental: Men with low to intermediate risk prostate cancer Once a patient is deemed eligible, they will be scheduled for treatment with SBRT, which should be completed within 14 days of screening. Follow up will occur 30 days post radiation and every 4 months, post- radiation for the first 2 years. After the first 2 years of follow up, visits will occur every 6 months until year 5. |
Radiation: Two-Fraction Stereotactic Body Radiation Therapy (SBRT) |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
NYU Langone Hospital - Long Island
Mineola, New York, United States, 11501
Recruiting
CyberKnife at Perlmutter Cancer Center
New York, New York, United States, 10016