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Analysis of the Mechanisms of Actions of Heat Shock Protein (Hsp27) Responsible of the Androgen-independent Evolution in Prostate Cancer

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ClinicalTrials.gov Identifier: NCT02055846
Recruitment Status : Terminated (Insufficient biological material for analysis)
First Posted : February 5, 2014
Last Update Posted : June 25, 2015
Sponsor:
Information provided by (Responsible Party):
Institut Paoli-Calmettes

Brief Summary:
Prostate cancer (PC) represents one of the most common cancers in industrialized countries. Patients with localized disease may be treated with surgery or radiation, while androgen ablation is used as first-line therapy in patients with metastatic disease. While most patients initially respond well to this hormonal therapy, they most ultimately become unresponsive and recur within 2 years as androgen-independent prostate cancer (AIPC). Recently, docetaxel-based regimens have demonstrated improved survival in men with AIPC in two different, large, phase III studies. However, the median overall survival was prolonged for only 2 or 3 months. Androgen independent (AI) progression involves variable combinations of clonal selection, adaptive up-regulation of anti-apoptotic genes, ligand-independent androgen receptor (AR) activation, alternative growth factor pathways, and immune system escape. Additional therapeutic strategies targeting molecular mechanisms mediating resistance, combined with immunotherapy must be developed. One strategy to improve therapies in advanced PC involves targeting genes that are activated by androgen withdrawal, either to delay or prevent the emergence of the resistant AI phenotype. Recently, a scientist,identified Heat Shock Protein (Hsp27) as a highly over-expressed gene in AIPC. Hsp27 knockdown using antisens oligonucleotides (ASO) and small interfering RNA (siRNA) increased apoptotic rates and enhanced hormone- and chemo-therapy in PC. She developed and patented a 2nd generation ASO targeting Hsp27 that has been licensed (investigational drug called OGX-427) and clinical trials phase I/II is currently in process in PC. Despite OGX-427 efficiency, the functional role of stress induced Hsp27 in castration or chemotherapy-induced apoptosis remains undefined. The purpose of this study is to elucidate the pathways leading to Hsp27 action in androgen-independent prostate cancer in order to 1/ Increase the pharmacological safety of OGX-427 and 2/find new specific therapeutic targets and treatment strategy for androgen-independent prostate cancer .

Condition or disease Intervention/treatment Phase
Androgen-independent Prostate Cancer Procedure: Realisation of blood sample, urinary sample and tumor biopsy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Analysis of the Mechanisms of Actions of Hsp27 Responsible of the Androgen-independent Evolution in Prostate Cancer
Study Start Date : March 2012
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: prostate cancer
Realisation of blood sample, urinary sample and tumor biopsy
Procedure: Realisation of blood sample, urinary sample and tumor biopsy



Primary Outcome Measures :
  1. Level of Hsp27 protein [ Time Frame: within 24 hours ]
    Mechanisms of action of Hsp27 protein to elucidate the pathways leading to Hsp27 action in androgen-independent prostate cancer (AIPC) by double hybrid Sos Recruitment System (SRS)


Secondary Outcome Measures :
  1. Targets for OGX-427 [ Time Frame: within 24 hours ]
    Description of new specific therapeutic targets for androgen-independent prostate cancer and pharmacological safety of OGX-427



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Prostate adenocarcinoma
  • Patient > 18 years old
  • Patient affiliated to a social security system or benefiting from such a system
  • Signed consent to participate

Exclusion Criteria:

  • Patient in emergency situation, major person being the object of a legal protective measure or unable to express its consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02055846


Locations
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France
Gwénaëlle GRAVIS, MD
Marseille, France, 13009
Sponsors and Collaborators
Institut Paoli-Calmettes
Investigators
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Principal Investigator: Gwénaëlle GRAVIS, MD Institut Paoli-Calmettes

Additional Information:
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Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT02055846     History of Changes
Other Study ID Numbers: PPPR / IPC 2012-002
First Posted: February 5, 2014    Key Record Dates
Last Update Posted: June 25, 2015
Last Verified: December 2012

Keywords provided by Institut Paoli-Calmettes:
Androgen-independent prostate cancer

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Genital Diseases, Male
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs