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Completed

NCT Number: NCT02282644

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Edouard Herriot - service d'urologie

Lyon, 69003, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bone marrow sampling

Biological

Primary outcomes

  1. Risk of death according to positive makers

    Time frame: Two years

Secondary outcomes

  1. Risk of clinical progression according to positive markers.

    Time frame: Two years

  2. Risk of biological progression according to positive markers.

    Time frame: Two years

  3. Risk of radiological progression according to positive markers.

    Time frame: Two years

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: PROMET II

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Nov 4, 2014
Registry last updated
Feb 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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