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

Clinique Mutualiste Chirurgicale de la Loire15 sites in 1 country100 target enrollmentDecember 2007

ConditionsProstate Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: Clinique Mutualiste Chirurgicale de la Loire
Enrollment: 100
Locations: 15
Primary Endpoint: Evaluates specific survival to 10 years
Status: Terminated
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2007

End Date

December 2013

Last Updated

10 years ago

Study Type

Observational

Sex

Male

Investigators

Sponsor

Clinique Mutualiste Chirurgicale de la Loire

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Evaluates specific survival to 10 years

Time Frame: 10 years

Secondary Outcomes

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)