This clinical trial tests the impact of radiation therapy (RT) using magnetic resonance imaging (MRI)- guided dosing on quality of life in patients with prostate cancer. Prostate tumor cells are typically located in specific areas and not in the entire prostate gland. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Current standard of care RT treats the entire prostate with high doses of radiation which can have significant side effects including rectal damage. MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. These pictures can show the difference between normal and diseased tissue and can be used to decrease the radiation dose to the areas of healthy tissue while increasing the radiation dose to the tumor cells. Giving higher doses of radiation to tumor cells and lower doses to the areas of the prostate that does not have tumor cells may be effective in treating patients with prostate cancer while decreasing bowel side effects and improving quality of life.
Additional locations may be listed on ClinicalTrials.gov for NCT06171269.
Locations matching your search criteria
United States
Illinois
Chicago
University of Chicago Comprehensive Cancer CenterStatus: Active
Contact: Stanley Lawrence Liauw
Phone: 773-702-6870
PRIMARY OBJECTIVE:
I. To evaluate patient reported rectal quality of life, 12-months post hypofractionated radiotherapy, with uninvolved prostate de-escalation and MRI based focal dose escalation to the dominant prostatic nodule.
SECONDARY OBJECTIVES:
I. To determine 2-year biochemical control following MRI-guided hypofractionated prostate RT utilizing a focal boost to intraprostatic lesions with dose de-escalation of the uninvolved prostate.
II. To assess physician-defined treatment-related toxicity and patient-reported quality of life for gastrointestinal, genitourinary, and sexual domains.
III. To correlate pre-RT radiographic findings with the results of 12-month post-RT prostate biopsy.
OUTLINE:
Patients undergo RT once daily (QD) on Monday-Friday for 4 weeks (20 fractions). Prior to starting RT, patients may receive androgen deprivation therapy (ADT) consisting of the combination of luteinizing hormone-releasing hormone (LHRH) analog and an anti-androgen, or bicalutamide alone or an LHRH analog alone for up to 6-24 months at the discretion of the treating radiation oncologist. Patients also undergo a biopsy, prostate MRI, computed tomography (CT), and optional prostate-specific membrane antigen (PSMA) positron emission tomography (PET) at pre-study, as well as optional biopsy post-treatment. Additionally, patients undergo blood sample collection throughout the study.
After completion of study treatment, patients are followed up every 3 months for at least 2 years.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationUniversity of Chicago Comprehensive Cancer Center
Principal InvestigatorStanley Lawrence Liauw
