Active Control of Prostatic Cancer With Criteria of Latence

NCT00921258 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2015-06-04

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Clinique Mutualiste Chirurgicale de la Loire

    lead OTHER

Principal Investigators

  • Nicolas MOTTET, Dr · Clinique Mutualiste Chirurgicale

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • France

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00921258 on ClinicalTrials.gov