PRO-STATE:Search for a Protein Profile Corresponding to Fast-developing Lesions and Characterization of Implicated Proteins in Prostate Carcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00427817
First received: January 26, 2007
Last updated: October 5, 2011
Last verified: October 2011
  Purpose

The main objective of this study is to realise serum protein profiles for each patient undergoing a prostate biopsy and to identify relevant proteins.


Condition
Adenoma, Prostatic

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: PRO-STATE: Prognostic Interest of Serum Protein Profiles of Patients Undergoing a Prostate Biopsy: Search for a Profile Corresponding to Fast-developing Lesions and Characterization of Implicated Proteins.

Further study details as provided by University Hospital, Grenoble:

Estimated Enrollment: 300
Study Start Date: August 2006
Study Completion Date: January 2011
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Detailed Description:

In men, prostate carcinoma is the first cancer and the second cause of death by cancer. It is a slowly evolving disease with no prognostic marker of poor outcome.

Currently, the Prostate Specific Antigen (PSA) is the only available biological marker. It is a tissue marker and not a tumoral pathology control.

This is why new tissue markers are urgently needed to select patients with unfavourable evolution, in order to treat them rapidly by more effective methods such as chemotherapy, hormonotherapy or radiotherapy. This could improve survival time and quality of life.

Proteomic and clinical data comparison could point to new relevant molecules and permit the development of new biological tests for routine use.

SELDI-TOF-MS (Surface Enhanced Laser Desorption/Ionisation Mass Spectrometry) permits an extremely sensitive analysis of proteins. This method has been substantially ratified by the literature and a number of markers have already been identified, particularly for several cancer pathologies.

As far as prostate carcinomas are concerned, previous proteomic researches on serum have led to diagnostic parameters, differentiating healthy patients, patients with benign lesion and patients having malignant lesions. However, at present, no relevant protein has been identified. Moreover, no study has been carried out to characterize fast-developing lesions, in order to anticipate response to treatments.

The main objective of this study is to realise serum protein profiles for each patient undergoing a prostate biopsy and to identify relevant proteins.

The main judgement criteria will be intensity peaks in the protein profile (area and height) with reference to combined criteria (PSA rate, clinical stage, Gleason score).

Two groups will be compared:

  • Group 1: Control (negative biopsy).
  • Group 2: Prostate carcinoma (positive biopsy).

This group will be subdivided:

  • Group 2a : favourable prognostic according to AMICO classification
  • Group 2b : intermediate or unfavourable prognostic according to AMICO classification

This will contribute to setting up an aftercare database combining clinical data with biological data and protein profile.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patient undergoing a prostate biopsy or a prostatectomy(according to common criteria).

Criteria

Inclusion Criteria:

  • Patient undergoing a prostate biopsy or a prostatectomy(according to common criteria).

Exclusion criteria:

  • Patient refusing to take part in the study.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00427817

Locations
France
Urology Department - University Hospital of Grenoble
Grenoble, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Jean Luc DESCOTES, MD 14th floor D, Urology Department
  More Information

Publications:

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT00427817     History of Changes
Other Study ID Numbers: DCIC 06 11
Study First Received: January 26, 2007
Last Updated: October 5, 2011
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Grenoble:
Adenoma, Prostatic
Prostate
Proteomics
Urology

Additional relevant MeSH terms:
Adenoma
Prostatic Hyperplasia
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Prostatic Diseases
Genital Diseases, Male

ClinicalTrials.gov processed this record on August 28, 2014