Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT00921258
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.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
74 Years
Study:
NCT00921258
Study Brief:
Protocol Section:
NCT00921258