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PROstate Cancer Medically Optimized Genome Enhanced ThErapy (PROMOTE)
This research trial studies gene expression in patients with prostate cancer that has spread to other places in the body receiving cytochrome P450 17 alpha hydroxylase/17,20 lyase (CYP-17) inhibition therapy. Studying samples of tissue, blood, and urine in the laboratory from patients receiving CYP-17 inhibition therapy may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer. It may also help doctors understand how well patients respond to treatment.
PRIMARY OBJECTIVES: I. To determine whether somatic tumor genome alterations identified in tumor tissue before or after the initiation of CYP-17 inhibition with abiraterone acetate therapy are associated with a 12-week composite progression free survival (PFS) endpoint. II. To use tumor tissue obtained prior to the initiation of therapy and from the 12 week biopsy to develop tumor xenografts for mechanistic and functional studies which will determine whether mutations identified in the tumor genome are associated with response to drugs that target the observed mutated genes and/or associated pathways. SECONDARY OBJECTIVES: I. To determine whether somatic tumor genome alterations identified before or after initiating CYP-17 inhibition with abiraterone acetate therapy are associated with overall survival. II. To determine whether somatic tumor genome alterations identified in tumor tissue before or after the initiation of CYP-17 inhibition with abiraterone acetate therapy are associated with progression free survival (PFS). III. To evaluate circulatory markers in blood and urine specimens for response and/or resistance to treatment. (Exploratory and correlative objectives) OUTLINE: Tissue, blood, and urine samples are collected at baseline and after 12-14 weeks of treatment and assessed for circulating tumor cells, genome-wide single-nucleotide polymorphism (SNP), and exome sequencing.
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
No
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Mayo Clinic
Rochester, Minnesota, United States
Start Date
May 30, 2013
Primary Completion Date
December 3, 2015
Completion Date
December 15, 2026
Last Updated
February 3, 2026
92
ACTUAL participants
Laboratory Biomarker Analysis
OTHER
Quality-of-Life Assessment
OTHER
Lead Sponsor
Mayo Clinic
Collaborators
NCT05691465
NCT04550494
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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