Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry (PROMET II)

February 16, 2018 updated by: Hospices Civils de Lyon
The recent data suggest that cancer cells at the origin of prostate cancer metastases can be detected in an early stage. Available techniques allow phenotypic analysis of cancer cells in circulating blood (cellsearch) or in marrow hematopoietic (flow cytometry). Pilot study on 180 patients infected by prostate cancer at all stage of disease, show that c-met marker , integrin alpha 2 and 6 expressed in marrow and quantified by flow cytometry were predictor of metastatic progress. In this new study the investigators will analyze antibody panel by cellsearch and flow cytometry on marrow sample of castration-Resistant prostate cancer patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69003
        • Hôpital Edouard Herriot - service d'urologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma or prostate
  • Ongoing effective androgen deprivation therapy (testosterone ≤ 50 ng/mL)
  • Castration-Resistant prostate cancer patient : defined as a minimum of 3 rising PSA values assessed and/or radiological progress confirmed by RECIST and PCWG2
  • Patient who signed informed consent

Exclusion Criteria:

  • Severe disorders of coagulation
  • Major skin lesion on iliac crests
  • Allergies in local anesthetics
  • Psychological instability or psychiatric histories
  • Uncertain follow-up and distant residence
  • History of another invasive cancer and hematologic disease
  • Patient deprived of their freedom by court or administrative order
  • Revocation of consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CellSearch
Biological: Bone marrow sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Risk of death according to positive makers
Time Frame: Two years
Two years

Secondary Outcome Measures

Outcome Measure
Time Frame
Risk of clinical progression according to positive markers.
Time Frame: Two years
Two years
Risk of biological progression according to positive markers.
Time Frame: Two years
Two years
Risk of radiological progression according to positive markers.
Time Frame: Two years
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2014

Primary Completion (Actual)

August 25, 2017

Study Completion (Actual)

August 25, 2017

Study Registration Dates

First Submitted

October 31, 2014

First Submitted That Met QC Criteria

November 3, 2014

First Posted (Estimate)

November 4, 2014

Study Record Updates

Last Update Posted (Actual)

February 22, 2018

Last Update Submitted That Met QC Criteria

February 16, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013.824

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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