Analysis of the Mechanisms of Actions of Heat Shock Protein (Hsp27) Responsible of the Androgen-independent Evolution in Prostate Cancer
Primary Purpose
Androgen-independent Prostate Cancer
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Realisation of blood sample, urinary sample and tumor biopsy
Sponsored by
About this trial
This is an interventional basic science trial for Androgen-independent Prostate Cancer focused on measuring Androgen-independent prostate cancer
Eligibility 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
Sites / Locations
- Gwénaëlle GRAVIS, MD
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
prostate cancer
Arm Description
Realisation of blood sample, urinary sample and tumor biopsy
Outcomes
Primary Outcome Measures
Level of Hsp27 protein
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
Targets for OGX-427
Description of new specific therapeutic targets for androgen-independent prostate cancer and pharmacological safety of OGX-427
Full Information
NCT ID
NCT02055846
First Posted
October 26, 2012
Last Updated
June 24, 2015
Sponsor
Institut Paoli-Calmettes
1. Study Identification
Unique Protocol Identification Number
NCT02055846
Brief Title
Analysis of the Mechanisms of Actions of Heat Shock Protein (Hsp27) Responsible of the Androgen-independent Evolution in Prostate Cancer
Official Title
Analysis of the Mechanisms of Actions of Hsp27 Responsible of the Androgen-independent Evolution in Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Terminated
Why Stopped
Insufficient biological material for analysis
Study Start Date
March 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Paoli-Calmettes
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgen-independent Prostate Cancer
Keywords
Androgen-independent prostate cancer
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
prostate cancer
Arm Type
Experimental
Arm Description
Realisation of blood sample, urinary sample and tumor biopsy
Intervention Type
Procedure
Intervention Name(s)
Realisation of blood sample, urinary sample and tumor biopsy
Primary Outcome Measure Information:
Title
Level of Hsp27 protein
Description
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)
Time Frame
within 24 hours
Secondary Outcome Measure Information:
Title
Targets for OGX-427
Description
Description of new specific therapeutic targets for androgen-independent prostate cancer and pharmacological safety of OGX-427
Time Frame
within 24 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gwénaëlle GRAVIS, MD
Organizational Affiliation
Institut Paoli-Calmettes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gwénaëlle GRAVIS, MD
City
Marseille
ZIP/Postal Code
13009
Country
France
12. IPD Sharing Statement
Links:
URL
http://www.institutpaolicalmettes.fr
Description
official web site of the sponsor
Learn more about this trial
Analysis of the Mechanisms of Actions of Heat Shock Protein (Hsp27) Responsible of the Androgen-independent Evolution in Prostate Cancer
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