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Androgen Receptor (AR) Activity in Castration-Resistant Prostate Cancer (CRPC) and Response to Ketoconazole


N/A
N/A
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

Androgen Receptor (AR) Activity in Castration-Resistant Prostate Cancer (CRPC) and Response to Ketoconazole


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.

Inclusion 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

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Progression-free survival (PFS) of men treated with ketoconazole

Safety Issue:

No

Principal Investigator

Mary-Ellen Taplin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

Unspecified

Study ID:

CDR0000688286

NCT ID:

NCT01275651

Start Date:

December 2010

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • recurrent prostate cancer
  • Prostatic Neoplasms

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