Clinical trial NCT00921258: Active Control of Prostatic Cancer With Criteria of Latence
Official title: Active Control of Prostatic Cancer With Criteria of Latence. Impact on Specific 10 Years Survival.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Prostate Cancer
Keywords: latent prostate cancer
Patient with latent prostate cancer
PSA ≤ 10 ng/ml
Clinical stage T1c or T2a
Patient who accept just be control
Lead sponsor: Clinique Mutualiste Chirurgicale de la Loire
Sponsor class: OTHER
First posted: 2009-06-16
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with latent prostate cancer who agree to be controlled instead of to be immediately treated for this cancer

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.

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
* 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.

Primary outcomes:
measure: Evaluates specific survival to 10 years
timeFrame: 10 years
Secondary outcomes:
measure: To evaluate acceptation of 2nd biopsy to confirm latent cancer
timeFrame: 10 years
measure: To evaluate global survival of patient in control
timeFrame: 10 years
measure: To evaluate the survival of patient with a secondary active treatment after a control period
timeFrame: 10 years
measure: To evaluate delay to secondary treatment after a period control
timeFrame: 10 years
measure: To evaluate survival rate without biological or clinical progression of cancer
timeFrame: 10 years
measure: To evaluate quality of life
timeFrame: 10 years
Other outcomes:
Locations:
city: Angers
country: France
facility: R Azzouzi
city: Avignon
country: France
facility: Jean-Louis DAVIN
city: Caen
country: France
facility: Henri BENSADOUN
city: Creteil
country: France
facility: SALOMON
city: La Roche Sur Yon
country: France
facility: René GASCHIGNARD
city: Lyon
country: France
facility: RUFFION
city: Marseille
country: France
facility: Eric LECHEVALLIER
city: Marseille
country: France
facility: P. ROSSI
city: Montpellier
country: France
facility: Xavier REBILLARD
city: Nantes
country: France
facility: RIGAUD Jérôme
city: NiMES
country: France
facility: Christophe AVANCES
city: Poitiers
country: France
facility: IRANI Jacques
city: Pontoise
country: France
facility: P Colloby
city: Saint-etienne
country: France
facility: Clinique Mutualiste Chirurgicale
city: Toulouse
country: France
facility: SOULIE Michel
Study officials:
affiliation: Clinique Mutualiste Chirurgicale
name: Nicolas MOTTET, Dr
role: PRINCIPAL_INVESTIGATOR
References: