Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry
PROMET II
1 other identifier
interventional
17
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable prostate-cancer
Started Sep 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 8, 2014
CompletedFirst Submitted
Initial submission to the registry
October 31, 2014
CompletedFirst Posted
Study publicly available on registry
November 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 25, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 25, 2017
CompletedFebruary 22, 2018
February 1, 2018
3 years
October 31, 2014
February 16, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Risk of death according to positive makers
Two years
Secondary Outcomes (3)
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
Study Arms (1)
CellSearch
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Edouard Herriot - service d'urologie
Lyon, 69003, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2014
First Posted
November 4, 2014
Study Start
September 8, 2014
Primary Completion
August 25, 2017
Study Completion
August 25, 2017
Last Updated
February 22, 2018
Record last verified: 2018-02