Active Control of Prostatic Cancer With Criteria of Latence
NCT ID: NCT00921258
Last Updated: 2015-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
100 participants
OBSERVATIONAL
2007-12-31
2013-12-31
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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control group
Patient with latent prostate cancer who agree to be controled instead of to be treated
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
74 Years
MALE
No
Sponsors
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Clinique Mutualiste Chirurgicale de la Loire
OTHER
Responsible Party
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Principal Investigators
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Nicolas MOTTET, Dr
Role: PRINCIPAL_INVESTIGATOR
Clinique Mutualiste Chirurgicale
Locations
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R Azzouzi
Angers, , France
Jean-Louis DAVIN
Avignon, , France
Henri BENSADOUN
Caen, , France
SALOMON
Créteil, , France
René GASCHIGNARD
La Roche-sur-Yon, , France
RUFFION
Lyon, , France
Eric LECHEVALLIER
Marseille, , France
P. ROSSI
Marseille, , France
Xavier REBILLARD
Montpellier, , France
RIGAUD Jérôme
Nantes, , France
Christophe AVANCES
Nîmes, , France
IRANI Jacques
Poitiers, , France
P Colloby
Pontoise, , France
Clinique Mutualiste Chirurgicale
Saint-Etienne, , France
SOULIE Michel
Toulouse, , France
Countries
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Other Identifiers
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2007-A00871-52
Identifier Type: -
Identifier Source: secondary_id
0700043
Identifier Type: -
Identifier Source: org_study_id
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