This early phase I trial uses fluorine F 18 piflufolastat with positron emission tomography (PET)/magnetic resonance imaging (MRI) to identify image-based biomarkers of treatment response in patients undergoing external beam radiation therapy, high dose rate brachytherapy, and androgen deprivation therapy for high risk prostate cancer. Biomarkers are found in blood, other body fluids, or body tissue. Biomarkers can be used to see how well the body responds to cancer treatment. Fluorine F 18 piflufolastat is an imaging agent. Upon administration of fluorine F 18 piflufolastat, it binds to a receptor expressed on prostate tumor cells, allowing them to be seen on imaging scans. PET and MRI are imaging techniques that can be used to provide detailed pictures of internal organs and tissues. The researchers would like to see how the body responds to standard of care therapy by using biomarkers on PET/MRI images to evaluate how well the treatment is working.
Additional locations may be listed on ClinicalTrials.gov for NCT05477823.
Locations matching your search criteria
United States
Wisconsin
Madison
University of Wisconsin Carbone Cancer Center - University HospitalStatus: Active
Contact: John M Floberg
Phone: 608-263-8500
University of Wisconsin Carbone Cancer Center - Eastpark Medical CenterStatus: Active
Contact: John M Floberg
PRIMARY OBJECTIVE:
I. Identify an imaging-based biomarker from prostate specific membrane antigen (PSMA) PET and/or MRI that identifies patients at risk for poor response to definitive radiation therapy for high-risk prostate cancer.
SECONDARY OBJECTIVES:
I. Determine if the Post-Operative Radiation Therapy Outcomes Score (PORTOS) and basal/luminal subtype genomic signatures are associated with change in PSMA signal pre-to-mid-treatment.
II. Establish a relationship between imaging response and pathologic response to androgen deprivation therapy (ADT) and external beam radiation therapy (EBRT) on a lesion-by-lesion basis.
III. Determine if imaging and genomic markers that predict for mid-treatment pathologic response also predict prostate specific antigen (PSA) recurrence.
IV. Evaluate blood-based biomarkers, including circulating tumor cells and circulating tumor deoxyribonucleic acid (DNA), as potential predictors of response to ADT and EBRT.
EXPLORATORY OBJECTIVES:
I. Evaluate changes in gene expression from pre- to mid-treatment, and their association with response to therapy.
II. Evaluate higher order radiomic metrics (e.g. measures of lesion heterogeneity) as potential predictive markers for response to ADT and EBRT.
OUTLINE:
Patients undergoing standard of care (SOC) intensity-modulated radiation therapy (IMRT), high dose rate (HDR) brachytherapy, and ADT receive fluorine F 18 piflufolastat via standard route of administration, and undergo PET/MRI over 90 minutes or PET/computed tomography (CT) over 30-45 minutes at the mid-treatment timepoint between IMRT and brachytherapy. Patients also undergo PET/MRI or PET/CT during screening as well as image guided biopsy and collection of blood samples during screening and on the trial.
Upon completion of study treatment, patients are followed up at 3 and 6 months and then every 6 months for 5 years total.
Lead OrganizationUniversity of Wisconsin Carbone Cancer Center - University Hospital
Principal InvestigatorJohn M Floberg