Active Control of Prostatic Cancer With Criteria of Latence

Terminated

• Conditions: Prostate Cancer
• Interventions: Procedure: prostate biopsy

• Registration Number: NCT00921258
• Lead Sponsor: Clinique Mutualiste Chirurgicale de la Loire

Brief 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.

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2009-06-12
• Study First Submitted QC: 2009-06-15
• Study First Posted: 2009-06-16
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-03
• Last Update Posted: 2015-06-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

• patient with a latent prostatic cancer
• aged less 75 years old,
• life expectation higher than 10 years
• Clinic statue T1c or T2a
• with a seric PSA (prostatic specific antigen)smaller than 10ng/ml
• more than 10 biopsy cores samples
• patient with less than 3 cores samples with tumor and none care sample with more than 3mm of tumor
• Gleason score inferior at 7
• patient's agreement about project and a second biopsy which will include definitive patient: realized 3 months after the first and having: 14 biopsy cores samples (10 like previously and 4 more specific: taking around the positives initials biopsies), less than 3 cores samples with tumor, ,any cores samples with more than 3mm of tumor, a Gleason score superior at 7.

Exclusion Criteria

• patient aged 75 years old and more
• no patient's agreement
• lack of understanding of plan
• patient with guardianship
• life expectation smaller than 10 years
• patient with an other cancer less than 5 years
• Local clinical statue greater than T2a
• seric PSA higher than 10ng/ml
• less than 10 biopsies
• more than 2 positives biopsies during the first intervention
• 3 cores samples with more than 3mm of tumor
• 4th grade on the biopsies
• patient's refuse to realize the second biopsies
• patient who ask a treatment after the first medical examination
• patient with less 4 special biopsies around the previously initial cores samples or more than 2 positives biopsies or biopsies with more than 3mm of tumor or patient having a 4 grade on biopsies, during the second medical examination.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
control group	prostate biopsy	Patient with latent prostate cancer who agree to be controled instead of to be treated

Primary Outcome Measures

Name	Time	Method
Evaluates specific survival to 10 years	10 years

Secondary Outcome Measures

Name	Time	Method
To evaluate global survival of patient in control	10 years
To evaluate the survival of patient with a secondary active treatment after a control period	10 years
To evaluate delay to secondary treatment after a period control	10 years
To evaluate acceptation of 2nd biopsy to confirm latent cancer	10 years
To evaluate survival rate without biological or clinical progression of cancer	10 years
To evaluate quality of life	10 years

Trial Locations

Locations (15)

R Azzouzi; 🇫🇷 Angers, France

Henri BENSADOUN; 🇫🇷 Caen, France

Jean-Louis DAVIN; 🇫🇷 Avignon, France

SALOMON; 🇫🇷 Creteil, France

René GASCHIGNARD; 🇫🇷 La Roche Sur Yon, France

SOULIE Michel; 🇫🇷 Toulouse, France

RUFFION; 🇫🇷 Lyon, France

Eric LECHEVALLIER; 🇫🇷 Marseille, France

Xavier REBILLARD; 🇫🇷 Montpellier, France

RIGAUD Jérôme; 🇫🇷 Nantes, France

Christophe AVANCES; 🇫🇷 NiMES, France

IRANI Jacques; 🇫🇷 Poitiers, France

P Colloby; 🇫🇷 Pontoise, France

Clinique Mutualiste Chirurgicale; 🇫🇷 Saint-etienne, France

P. ROSSI; 🇫🇷 Marseille, France