Biomarkers in Bone Marrow and Blood Samples From Patients With Prostate Cancer Treated With Ketoconazole

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
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
  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)
Detailed Description:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01275651

Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Principal Investigator: Mary-Ellen Taplin, MD Dana-Farber Cancer Institute
  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:
Genital Diseases, Male
Prostatic Diseases
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Ketoconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014