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Prostate Cancer Evaluation of TaRgets in Genito Urinary Screening Program (PETRUS)

Primary Purpose

Metastatic Castration Resistant Prostate Cancer Patients

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
metastasis biopsy
Sponsored by
Gustave Roussy, Cancer Campus, Grand Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Metastatic Castration Resistant Prostate Cancer Patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Prostate Cancer patients
  • Castration Resistant
  • Prostatic tissue available
  • Metastasis which may be biopsied

Exclusion Criteria:

Sites / Locations

  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

experimental

Arm Description

metastasis biopsy

Outcomes

Primary Outcome Measures

Biomarker
success to evaluate at least one molecular analysis in tumor tissues (prostate and/or metastatic site) AND in CTC

Secondary Outcome Measures

Full Information

First Posted
December 3, 2012
Last Updated
February 5, 2016
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
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1. Study Identification

Unique Protocol Identification Number
NCT01786031
Brief Title
Prostate Cancer Evaluation of TaRgets in Genito Urinary Screening Program
Acronym
PETRUS
Official Title
Prostate Cancer Evaluation of TaRgets in Genito Urinary Screening Program
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Toward personalised treatment in early metastatic prostate cancer based on the assessment of biomarkers in cancer tissue samples and circulating tumour cells.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Castration Resistant Prostate Cancer Patients

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental
Arm Type
Experimental
Arm Description
metastasis biopsy
Intervention Type
Other
Intervention Name(s)
metastasis biopsy
Primary Outcome Measure Information:
Title
Biomarker
Description
success to evaluate at least one molecular analysis in tumor tissues (prostate and/or metastatic site) AND in CTC
Time Frame
assessed at the end of recruitment, up to 2 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Prostate Cancer patients Castration Resistant Prostatic tissue available Metastasis which may be biopsied Exclusion Criteria:
Facility Information:
Facility Name
Institut Gustave Roussy
City
Villejuif
State/Province
Val de Marne
ZIP/Postal Code
94805
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
26923772
Citation
Lindsay CR, Le Moulec S, Billiot F, Loriot Y, Ngo-Camus M, Vielh P, Fizazi K, Massard C, Farace F. Vimentin and Ki67 expression in circulating tumour cells derived from castrate-resistant prostate cancer. BMC Cancer. 2016 Feb 29;16:168. doi: 10.1186/s12885-016-2192-6.
Results Reference
derived

Learn more about this trial

Prostate Cancer Evaluation of TaRgets in Genito Urinary Screening Program

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