Clinical trial NCT00427817: PRO-STATE:Search for a Protein Profile Corresponding to Fast-developing Lesions and Characterization of Implicated Proteins in Prostate Carcinoma
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adenoma, Prostatic
Keywords: Adenoma, Prostatic
Prostate
Proteomics
Urology
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2007-01-29
Enrollment: 300
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient undergoing a prostate biopsy or a prostatectomy(according to common criteria).

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.

Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Urology Department - University Hospital of Grenoble
Study officials:
affiliation: 14th floor D, Urology Department
name: Jean Luc DESCOTES, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stattin P, Hakama M. Correspondence re: B-L. Adam et al., Serum protein fingerprinting coupled with a pattern-matching algorithm distinguishes prostate cancer from benign prostate hyperplasia and healthy men. Cancer Res., 62: 3609-3614, 2002. Cancer Res. 2003 May 15;63(10):2701; author reply 2701-2. No abstract available.
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