Gene Expression in Patients With Metastatic Prostate Cancer Receiving CYP-17 Inhibition Therapy — PROMOTE  

Prostate Adenocarcinoma Clinical Trial

Official title: PROstate Cancer Medically Optimized Genome Enhanced ThErapy (PROMOTE)

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Carcinoma
• Hormone-Resistant Prostate Cancer
• Metastatic Prostate Carcinoma
• Prostate Adenocarcinoma
• Prostatic Neoplasms
• Recurrent Prostate Carcinoma

• NCT number: NCT01953640
• Study type: Observational
• Source: Mayo Clinic
• Status: Active, not recruiting
• Start date: May 28, 2013
• Completion date: June 30, 2024