New York, New York 10065


Purpose:

Prostate SBRT is a standard of care treatment for prostate cancer that has not spread to distant metastatic sites. Radiation is delivered to the prostate and seminal vesicles in 5 treatment sessions (fractions). Doses ranging from 35-45 Gy in 5 fractions have demonstrated good outcomes with acceptable toxicity. In this initial study, MRI guided treatment planning and delivery will be used to deliver 7 Gy to the entire prostate and seminal vesicles, with a selective boost of additional 0.5, 1.0, 1.5 or 2 Gy per fraction for total dose of 37.5, 40, 42.5 or 45 Gy to biopsy proven lesions, defined using MRI.


Study summary:

Prostate SBRT is a standard of care treatment for prostate cancer that has not spread to distant metastatic sites. Radiation is delivered to the prostate and seminal vesicles in 5 treatment sessions (fractions). Doses ranging from 35-45 Gy in 5 fractions have demonstrated good outcomes with acceptable toxicity. In this initial study, MRI guided treatment planning and delivery will be used to deliver 7 Gy to the entire prostate and seminal vesicles, with a selective boost of additional 0.5, 1.0, 1.5 or 2 Gy per fraction for total dose of 37.5, 40, 42.5 or 45 Gy to biopsy proven lesions, defined using MRI. Hypothesis: MRI-guided treatment planning and delivery can selectively target high-risk prostate nodules and deliver a higher radiation dose, to achieve maximal local control without increasing treatment toxicity


Criteria:

Inclusion Criteria: 1. Biopsy-proven diagnosis of prostate adenocarcinoma 2. NCCN defined low-, intermediate- and high-risk prostate cancer 3. Age ≥ 18 4. Patient must have prostate MRI with a PIRADS 3-5 lesion or PSMA PET with an avid intraprostatic lesion Exclusion Criteria: 1. History of prior pelvic radiation (external beam or brachytherapy) 2. Inability to undergo MRI 3. Patients with metastatic disease (other than pelvic lymph nodes) are ineligible for this study 4. AUA score >17 - AUA score >17


NCT ID:

NCT03664193


Primary Contact:

Principal Investigator
Josephine Kang, M.D.
Weill Cornell Medicine - New York Presbyterian Hospital

Sharanya Chandrasekhar, M.S.
Phone: 646-962-2196
Email: shc2043@med.cornell.edu


Backup Contact:

Email: pry2003@med.cornell.edu
Pragya Yadav, Ph.D.
Phone: 646-962-2199


Location Contact:

New York, New York 10065
United States

Sharanya Chandrasekhar, M.S.
Phone: 646-962-2196
Email: shc2043@med.cornell.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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