NCT01786031

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 7, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

February 8, 2016

Status Verified

February 1, 2016

Enrollment Period

2.1 years

First QC Date

December 3, 2012

Last Update Submit

February 5, 2016

Conditions

Metastatic Castration Resistant Prostate Cancer Patients

Outcome Measures

Primary Outcomes (1)

  • Biomarker

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

    assessed at the end of recruitment, up to 2 years

Study Arms (1)

experimental

EXPERIMENTAL

metastasis biopsy

Other: metastasis biopsy

Interventions

metastasis biopsyOTHER
experimental

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Gustave Roussy

Villejuif, Val de Marne, 94805, France

Location

Related Publications (1)

  • 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.

    PMID: 26923772DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2012

First Posted

February 7, 2013

Study Start

December 1, 2012

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

February 8, 2016

Record last verified: 2016-02

Locations

FR(1)