PROstate Cancer Medically Optimized Genome Enhanced ThErapy (PROMOTE)
Overview
- Phase
- N/A
- Intervention
- Laboratory Biomarker Analysis
- Conditions
- Hormone-Resistant Prostate Cancer
- Sponsor
- Mayo Clinic
- Enrollment
- 92
- Locations
- 3
- Primary Endpoint
- Occurrence of PFS as defined by Prostate Cancer Working Group 2 criteria
- Status
- Active, Not Recruiting
- Last Updated
- 2 months ago
Overview
Brief 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.
Detailed 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histological diagnosis of adenocarcinoma of the prostate or documented history in medical records of having received treatment for prostate cancer diagnosis
- •Metastatic disease on chest, abdominal, or pelvic computed tomography (CT) and/or bone scan amenable to biopsy
- •Hemoglobin (HgB) \> 9.0 gm
- •Absolute neutrophil count (ANC) \>= 1500 cells/L
- •Platelets \>= 100,000 u/L
- •Creatinine =\< 1.5 x upper limit of normal (ULN)
- •Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase (AST)) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase (ALT)) =\< 1.5 x ULN
- •Castrate serum testosterone level (\< 50 ng/dL -or- \< 1.7 nmol/L)
- •Progression while on or after androgen deprivation therapy defined as:
- •Progressive measurable disease: at least a 20% increase in the sum of the longest diameters of measurable lesions over the smallest sum observed or the appearance of one or more new lesions as assessed by imaging during hormone ablation treatment; measurable lesions are nodal or visceral soft-tissue lesions with nodal lesions \>= 20 mm in diameter or visceral/soft-tissue lesions \>= 10 mm in diameter OR
Exclusion Criteria
- •Use of any of these therapies =\< 12 months prior to registration:
- •Use of any of the standard therapies for castrate resistant prostate cancer (CRPC) stage =\< 12 months prior to registration; Note: see below for further exclusion details of specific standard therapies
- •Initiation of full dose chemotherapy with docetaxel for CRPC stage =\< 12 months prior to registration is an exclusion criterion
- •Note: docetaxel for hormone sensitive prostate cancer is not an exclusion criterion
- •Use of radium-223 for CRPC stage is an exclusion criteria
- •Use of Provenge vaccine for CRPC =\< 12 months prior to registration is an exclusion criterion
- •Note: less than 3 doses of Provenge vaccine =\< 12 months prior to registration for CRPC is not an exclusion criterion
- •Initiation of full dose chemotherapy with mitoxantrone for CRPC stage with-in the previous 12 months is an exclusion criterion
- •Use of cabazitaxel chemotherapy =\< 12 months prior to registration is an exclusion criterion
- •Note: initiation of full dose chemotherapy with cabazitaxel for CRPC stage with-in the previous 12 months is an exclusion criterion
Arms & Interventions
Ancillary-correlative (gene expression with CYP-17 inhibition)
Laboratory Biomarker Analysis: Tissue, blood, and urine samples are collected at baseline and after 12-14 weeks of treatment and assessed for circulating tumor cells, genome-wide SNP, and exome sequencing. Subjects will also receive a Quality-of-Life Assessment.
Intervention: Laboratory Biomarker Analysis
Ancillary-correlative (gene expression with CYP-17 inhibition)
Laboratory Biomarker Analysis: Tissue, blood, and urine samples are collected at baseline and after 12-14 weeks of treatment and assessed for circulating tumor cells, genome-wide SNP, and exome sequencing. Subjects will also receive a Quality-of-Life Assessment.
Intervention: Quality-of-Life Assessment
Outcomes
Primary Outcomes
Occurrence of PFS as defined by Prostate Cancer Working Group 2 criteria
Time Frame: Up to 14 weeks
Secondary Outcomes
- PFS after receiving abiraterone acetate(Up to 5 years)
- Overall survival after receiving abiraterone acetate(Up to 5 years)