Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatment bone marrow sampling
Sponsor Hospices Civils de Lyon
Start date September 2014
End date August 2018
Trial size 60 participants
Trial identifier NCT02282644, 2013.824

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
bone marrow sampling

Primary Outcomes

Measure
Risk of death according to positive makers
time frame: Two years

Secondary Outcomes

Measure
Risk of clinical progression according to positive markers.
time frame: Two years
Risk of biological progression according to positive markers.
time frame: Two years
Risk of radiological progression according to positive markers.
time frame: Two years

Eligibility Criteria

Male participants at least 18 years old.

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

Additional Information

Official title Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Hospices Civils de Lyon.