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

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Biological: Bone marrow sampling

• Registration Number: NCT02282644
• Lead Sponsor: Hospices Civils de Lyon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-08
• Study First Submitted: 2014-10-31
• Study First Submitted QC: 2014-11-03
• Study First Posted: 2014-11-04
• Primary Completion: 2017-08-25
• Study Completion: 2017-08-25
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-16
• Last Update Posted: 2018-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 17

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CellSearch	Bone marrow sampling	-

Primary Outcome Measures

Name	Time	Method
Risk of death according to positive makers	Two years

Secondary Outcome Measures

Name	Time	Method
Risk of clinical progression according to positive markers.	Two years
Risk of biological progression according to positive markers.	Two years
Risk of radiological progression according to positive markers.	Two years

Trial Locations

Locations (1)

Hôpital Edouard Herriot - service d'urologie; 🇫🇷 Lyon, France