This phase I trial evaluates the use of radiation therapy at different dose levels in treating prostate cancer patients. Radiation therapy is a type of cancer treatment that uses beams of intense energy to kill cancer cells. Hypofractionated radiation therapy delivers a higher dose of radiation precisely to the cancer, with the surrounding tissues receiving a low enough dose to remain free from injury. Information from this study will help researchers learn more about the safety of using hypofractionated radiation therapy as a treatment for prostate cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04486755.
Locations matching your search criteria
United States
Maryland
Baltimore
Maryland Proton Treatment CenterStatus: Active
Contact: Mark V. Mishra
Phone: 410-328-6080
University of Maryland/Greenebaum Cancer CenterStatus: Active
Contact: Mark V. Mishra
Phone: 410-328-6080
Bel Air
UM Upper Chesapeake Medical CenterStatus: Active
Contact: Mark V. Mishra
Phone: 410-328-6080
Columbia
Central Maryland Radiation Oncology in Howard CountyStatus: Active
Contact: Mark V. Mishra
Phone: 410-328-6080
Glen Burnie
UM Baltimore Washington Medical Center/Tate Cancer CenterStatus: Active
Contact: Mark V. Mishra
Phone: 410-328-6080
PRIMARY OBJECTIVES:
I. To determine the recommended dose-fractionation schedule for further study among three sequentially shorter radiation therapy (RT) schedules (20, 16, and 12 fraction) that are designed incrementally increase prostate cancer biologic equivalent dose (BED) but maintain a BED for normal tissue toxicity that is consistent with published regimens.
II. To determine the hypofractionated (HypoFx) RT schedule that results in < 33% acute (within 90 days of completing RT) dose-limiting toxicity with accelerated, HypoFx pelvic nodal RT delivered in combination with a HypoFx prostate simultaneous integrated boost (SIB).
SECONDARY OBJECTIVES:
I. To determine the frequency of acute (within 90 days completing RT) and late (> 90 days from treatment) gastrointestinal (GI) (small bowel and rectal), genitourinary (GU), hematologic, and neurologic toxicity for each dose cohort using the National Cancer Institute Common Terminology Criteria version (v.) 5.0 (NCI CTCAE v5).
II. To determine dose volume histogram (DVH) parameters that are associated with side effects to normal tissue complications for each dose cohort.
III. To evaluate, within the limitations of a Phase I trial, the duration of biochemical progression-free survival (bPFS).
IV. To evaluate patient reported outcomes (PROs) related to urinary and bowel function using PRO-CTCAE and QOL (urinary and bowel urgency and frequency using EPIC instrument).
OUTLINE: This is a dose-escalation study.
Patients undergo hypofractionated radiation therapy over 30 minutes, 4 days a week for 3-5 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 1 month, every 3 months for 1 year, and then every 6 months for 1 year.
Lead OrganizationUniversity of Maryland/Greenebaum Cancer Center
Principal InvestigatorMark V. Mishra