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

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.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00427817
Enrollment
300
Registered
2007-01-29
Start date
2006-08-31
Completion date
2011-01-31
Last updated
2011-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenoma, Prostatic

Keywords

Adenoma, Prostatic, Prostate, Proteomics, Urology

Brief summary

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

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.

Interventions

None listed

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Patient refusing to take part in the study.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026