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

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Civil Hospices of Lyon

Status

Completed

Conditions

Prostate Cancer

Treatments

Biological: Bone marrow sampling

Study type

Interventional

Funder types

Other

Identifiers

NCT02282644
2013.824

Details and patient eligibility

About

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.

Enrollment

17 patients

Sex

Male

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

17 participants in 1 patient group

CellSearch
Experimental group
Treatment:
Biological: Bone marrow sampling

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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