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Completed

NCT Number: NCT00427817

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

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

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Urology Department - University Hospital of Grenoble

Grenoble, 38043, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Patient refusing to take part in the study.

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study 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.

Important dates

Study start
2006
Primary completion
2009
Study completion
2011
First posted
Jan 29, 2007
Registry last updated
Oct 6, 2011

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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