Biomarkers in Bone Marrow and Blood Samples From Patients With Prostate Cancer Treated With Ketoconazole
This study is not yet open for participant recruitment.
Verified January 2011 by National Cancer Institute (NCI)
Sponsor:
Cancer and Leukemia Group B
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01275651
First received: January 11, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
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Purpose
RATIONALE: Studying samples of bone marrow and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This laboratory study is studying biomarkers in bone marrow and blood samples from patients with prostate cancer treated with ketoconazole.
| Condition | Intervention |
|---|---|
|
Prostate Cancer |
Genetic: gene expression analysis Genetic: microarray analysis Genetic: protein analysis Genetic: reverse transcriptase-polymerase chain reaction Other: immunohistochemistry staining method Other: laboratory biomarker analysis Other: mass spectrometry |
| Study Type: | Observational |
| Official Title: | Androgen Receptor (AR) Activity in Castration-Resistant Prostate Cancer (CRPC) and Response to Ketoconazole |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Progression-free survival (PFS) of men treated with ketoconazole [ Designated as safety issue: No ]
Secondary Outcome Measures:
- At least 30% decline in PSA from baseline [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
| Estimated Enrollment: | 48 |
| Study Start Date: | December 2010 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- To determine whether pre-treatment androgen receptor (AR) activity correlates with progression-free survival (PFS) of men with castration-resistant prostate cancer (CRPC) treated with ketoconazole.
Secondary
- To determine whether expression of androgen transport/synthesis/metabolism genes (including CYP17A1, AKR1C3, HSD3B2, HSD17B3, HSD17B6, AKR1C2, AKR1C1, UGTB15, UGTB17, SRD5A1, SRD5A2, SRD5A3, and SLCO2B1) correlate with detected AR activity, time to progression, and overall survival (OS) following treatment with ketoconazole.
- To determine whether semi-quantitative immunohistochemical analysis of AR and AKR1C3 protein levels correlate with PFS following treatment with ketoconazole.
- To determine whether specific AR splice variations correlate with PFS in response to ketoconazole.
- To determine whether detected activity of signaling pathways that interact with AR pathway activity (e.g., PI3K and downstream effectors, SRC, others) correlate with detected AR activity, PFS, and OS.
- To determine whether AR gene amplification correlates with detected AR activity and PFS on ketoconazole.
- To determine whether levels of testosterone and dihydrotestosterone from tumor tissue correlate with AR activity and PFS on ketoconazole.
- To determine the presence of specific prostate cancer-associated gene translocations in each sample of CRPC.
- To provide an unbiased data set of gene expression in CRPC that will markedly expand the currently available public domain data.
- To provide a library of amplified RNA and cDNA for further analysis by other investigators.
OUTLINE: This is a multicenter study.
Archived bone marrow tissue and blood samples are analyzed for androgen receptor (AR), AR splice variations, expression of androgen transport/synthesis/metabolism genes, AKR1C3 protein levels, and testosterone and dihydrotestosterone levels by RT-PCR, SNP microarrays, IHC, gene expression analysis, and mass spectrometry methods.
Eligibility| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of prostate cancer
Registered on clinical trials CLB-9583 and CALGB 9663
- Cohort of castration-resistant prostate cancer patients annotated with clinical response to ketoconazole
- Adequate tissue samples available
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Monica M. Bertagnolli, Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT01275651 History of Changes |
| Other Study ID Numbers: | CDR0000688286, CALGB-151004 |
| Study First Received: | January 11, 2011 |
| Last Updated: | January 11, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
adenocarcinoma of the prostate recurrent prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Ketoconazole |
14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antifungal Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on October 18, 2012
