This phase II trial tests how well a higher dose radiation works in treating the dominant prostate cancer lesion in patients with intermediate-risk prostate cancer. Radiation therapy (RT) uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Hypofractionated RT delivers higher doses of RT over a shorter period of time and may kill more tumor cells and have fewer side effects. The RT used in this trial is ultra-hypofractionated, delivering a higher dose of radiation to the dominant intraprostatic lesion (DIL), and delivering a standard, lower dose to surrounding areas, using a smaller number of treatments. The DIL is the most aggressive cancer lesion found in the prostate. Prior trials have shown higher rates of recurrence, cancer that has come back after a period of improvement, at the site of the DIL in particular. This recurrence could be related to lower than ideal doses of radiation delivered to the DIL. Giving a higher dose of radiation to the dominant prostate cancer lesion may be safe, tolerable and/or effective in treating patients with intermediate-risk prostate cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06542757.
Locations matching your search criteria
United States
New York
New York
Laura and Isaac Perlmutter Cancer Center at NYU LangoneStatus: Active
Contact: Michael J. Zelefsky
Phone: 646-501-8900
PRIMARY OBJECTIVES:
I. Estimate negative biopsy rates at 24 months post-treatment via repeat biopsy of the dominant lesion as seen on multiparametric magnetic resonance imaging (mp-MRI).
II. Estimate the serious toxicity rate at 24 months post-treatment.
SECONDARY OBJECTIVES:
I. Estimate prostate specific antigen (PSA) relapse rates at 24 months.
II. Estimate radiation-induced response rate in the dominant prostatic lesion using multi-parametric magnetic resonance (MR) imaging acquired 6 months and 24 months after radiation treatment.
III. Evaluate quality of life (QOL) outcomes related to urinary symptoms and sexual function utilizing International Prostatism Symptom Score (IPSS) and International Index of Erectile Function (IIEF) questionnaires respectively.
IV. Evaluate the baseline decipher scores on all patients and correlate with the 6 month and 24 month post-treatment targeted biopsies as well as the decipher assessments of post-treatment biopsies.
EXPLORATORY OBJECTIVE:
I. Estimate negative biopsy rates at 6 months post-treatment via repeat biopsy of the dominant lesion as seen on mp-MRI.
OUTLINE:
Patients undergo ultra-hypofractionated RT over several minutes every other day, Monday through Friday, for a total of 5 fractions. Additionally, patients undergo magnetic resonance imaging (MRI), prostate biopsy and blood sample collection throughout the trial as well as digital rectal examination (DRE) and rectal spacer (SpaceOAR) placement during screening. Patients also may undergo bone scan, computed tomography (CT) scan and rectal catheter placement during screening.
After completion of radiation treatment, patients are followed up at three and six months, and every six months thereafter through month 24.
Lead OrganizationLaura and Isaac Perlmutter Cancer Center at NYU Langone
Principal InvestigatorMichael J. Zelefsky
