PRO-STATE:Search for a Protein Profile Corresponding to Fast-developing Lesions and Characterization of Implicated Proteins in Prostate Carcinoma
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|ClinicalTrials.gov Identifier: NCT00427817|
Recruitment Status : Completed
First Posted : January 29, 2007
Last Update Posted : October 6, 2011
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Observational Model:||Case Control|
|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.|
|Study Start Date :||August 2006|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||January 2011|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00427817
|Urology Department - University Hospital of Grenoble|
|Grenoble, France, 38043|
|Principal Investigator:||Jean Luc DESCOTES, MD||14th floor D, Urology Department|