Biomarkers in Bone Marrow and Blood Samples From Patients With Prostate Cancer Treated With Ketoconazole
NCT ID: NCT01275651
Last Updated: 2019-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2010-12-31
2015-08-31
Brief Summary
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Detailed Description
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I. 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 OBJECTIVES:
I. To determine if expression of androgen transport/synthesis/metabolism genes (including cytochrome P450, family 17, subfamily A, polypeptide 1 \[CYP17A1\], aldo-keto reductase family 1 \[AKR1\]C3, hydroxy-delta-5-steroid dehydrogenase, 3 beta- and steroid delta-isomerase 2 \[HSD3B2\], hydroxysteroid \[17-beta\] dehydrogenase \[HSD17B\]3, HSD17B6, AKR1C2, AKR1C1, UGTB15, UGTB17, steroid-5-alpha-reductase, alpha polypeptide 1 \[3-oxo-5 alpha-steroid delta 4-dehydrogenase alpha\] \[SRD5A\]1, SRD5A2, SRD5A3, and solute carrier organic anion transporter family, member 2B1 \[SLCO2B1\]) correlate with detected AR activity, time to progression (progression free survival \[PFS\]) following treatment with ketoconazole, and overall survival.
II. To determine if semi-quantitative immunohistochemical analysis of AR and AKR1C3 protein levels correlate with PFS following treatment with ketoconazole.
III. To determine if specific AR splice variations correlate with PFS in response to ketoconazole.
IV. To determine if detected activity of signaling pathways that interact with AR pathway activity (e.g., phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha \[PI3K\] and downstream effectors, SRC proto-oncogene, non-receptor tyrosine kinase \[SRC\], others) correlate with detected AR activity, PFS, and OS.
V. To determine if AR gene amplification correlates with detected AR activity and PFS on ketoconazole.
VI. To determine if levels of testosterone and dihydrotestosterone (DHT) from tumor tissue correlate with AR activity and PFS on ketoconazole.
VII. To determine the presence of specific prostate cancer-associated gene translocations in each sample of CRPC.
VIII. To provide an unbiased data set of gene expression in CRPC that will markedly expand the currently available public domain data.
IX. To provide a library of amplified ribonucleic acid (RNA) and complementary (c)DNA for further analysis by other investigators.
OUTLINE:
Previously collected bone marrow, tissue, and blood samples are analyzed for AR activity, AR splice variations, expression of androgen transport/synthesis/metabolism genes, AKR1C3 protein levels, and testosterone and dihydrotestosterone levels via reverse transcription (RT)-polymerase chain reaction (PCR), single nucleotide polymorphisms (SNP) microarrays, immunohistochemistry (IHC), gene expression analysis, and mass spectrometry methods.
Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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Ancillary-Correlative (AR activity in CRPC)
Previously collected bone marrow tissue and blood samples are analyzed for AR activity, AR splice variations, expression of androgen transport/synthesis/metabolism genes, AKR1C3 protein levels, and testosterone and dihydrotestosterone levels via RT-PCR, SNP microarrays, IHC, gene expression analysis, and mass spectrometry methods.
laboratory biomarker analysis
Correlative studies
Interventions
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laboratory biomarker analysis
Correlative studies
Eligibility Criteria
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Inclusion Criteria
* Patients must have been registered to CALGB 9583 and CALGB 9663
* Adequate tissue specimen available for analysis
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Mary-Ellen Taplin, MD
Role: STUDY_CHAIR
Dana-Farber Cancer Institute
Locations
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Alliance for Clinical Trials in Oncology
Boston, Massachusetts, United States
Countries
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Other Identifiers
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CDR0000688286
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-2011-02835
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-151004
Identifier Type: -
Identifier Source: org_study_id
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