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

Prostate Cancer Clinical Trial

— PROMET II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02282644
• Other study ID #: 2013.824
• Status: Completed
• Phase: N/A
• First received: October 31, 2014
• Last updated: February 16, 2018
• Start date: September 8, 2014
• Est. completion date: August 25, 2017

Study information

• Verified date: February 2018
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: August 25, 2017
• Est. primary completion date: August 25, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Biological:
• Bone marrow sampling

Locations

Country	Name	City	State
France	Hôpital Edouard Herriot - service d'urologie	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk of death according to positive makers		Two years
Secondary	Risk of clinical progression according to positive markers.		Two years
Secondary	Risk of biological progression according to positive markers.		Two years
Secondary	Risk of radiological progression according to positive markers.		Two years