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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Bone marrow sampling
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Edouard Herriot - service d'urologie

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CellSearch

Arm Description

Outcomes

Primary Outcome Measures

Risk of death according to positive makers

Secondary Outcome Measures

Risk of clinical progression according to positive markers.
Risk of biological progression according to positive markers.
Risk of radiological progression according to positive markers.

Full Information

First Posted
October 31, 2014
Last Updated
February 16, 2018
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02282644
Brief Title
Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry
Acronym
PROMET II
Official Title
Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
September 8, 2014 (Actual)
Primary Completion Date
August 25, 2017 (Actual)
Study Completion Date
August 25, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CellSearch
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Bone marrow sampling
Primary Outcome Measure Information:
Title
Risk of death according to positive makers
Time Frame
Two years
Secondary Outcome Measure Information:
Title
Risk of clinical progression according to positive markers.
Time Frame
Two years
Title
Risk of biological progression according to positive markers.
Time Frame
Two years
Title
Risk of radiological progression according to positive markers.
Time Frame
Two years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hôpital Edouard Herriot - service d'urologie
City
Lyon
ZIP/Postal Code
69003
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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