NCT00921258

Active Control of Prostatic Cancer With Criteria of Latence

Active Control of Prostatic Cancer With Criteria of Latence. Impact on Specific 10 Years Survival.

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Clinique Mutualiste Chirurgicale de la Loire · Academic / Other
• Sex: Male
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

This study concern a prospective cohort pf patients with latent prostate cancer. We study the specific survival at 10 years of patients who accept an active control.Patients inclusion are realized in 2 stages: * patient with inclusion criteria (PSA \< 10 ng/ml, clinical stage T1c or T2a, Gleason \< or = 6) are registered if they accept a second prostate biopsy in a 3 months delay * after analyse of second biopsy in central laboratory and confirmation of latent prostate biopsy, patients are included if they accept active control Included patients will have 1 biopsy by years the first two years and then 1 biopsy each 2 years during 8 years. If progression of cancer happens during the 10 years control, active control will be stopped and patient will be treated by surgery and chemotherapy.

Detailed description

This study concern the active control during 10 years of patient with latent prostate cancer who accept not be treated immediately.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	prostate biopsy	patient of control group will have : * 1 prostate biopsy 3 months after diagnostic biopsy * 1 prostate biopsy each year during 2 years * 1 prostate biopsy each 2 years during 8 years

Timeline

• Start date: 2007-12-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2009-06-16
• Last updated: 2015-06-04

Locations

15 sites across 1 country: France