Status:
TERMINATED
Active Control of Prostatic Cancer With Criteria of Latence
Lead Sponsor:
Clinique Mutualiste Chirurgicale de la Loire
Conditions:
Prostate Cancer
Eligibility:
MALE
18-74 years
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 ...
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
- 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
- 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.
Key Trial Info
Start Date :
December 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00921258
Start Date
December 1 2007
End Date
December 1 2013
Last Update
June 4 2015
Active Locations (15)
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1
R Azzouzi
Angers, France
2
Jean-Louis DAVIN
Avignon, France
3
Henri BENSADOUN
Caen, France, 14000
4
SALOMON
Créteil, France