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 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 12:56 AM
NCT ID:
NCT07152067
Eligibility Criteria:
* Inclusion Criteria (all the criteria must be fulfilled ) :
* a. Localized prostate adenocarcinoma CAPRA score ≤ 5. This lesion is considered the Index lesion
* b. Macroscopic tumor PIRADS score \>4 on multiparametric MRI
* c. The biopsies must be pathologic in or in the direct vicinity (the same prostatic zone defined as a quarter volume of the prostate (PZ)) of the MRI pathologic nodule
* d. The absence of MRI pathologic criteria (PIRADS ≤3) in a Gleason score ≤ 6 (3+3)-ISUP Grade1 zone outside of the single Index lesion is considered clinically non-significant and does not preclude inclusion
* e. The lesion can be plurifocal in a same intent to treat PZ
* f. WHO Performance Status 0-1
* g. No major urinary symptoms with IPSS score ≤15 and urinary continence ICIQ score =0
* h. Patient is candidate for AS
* Exclusion Criteria :
* a. Age at diagnosis \< 50 years
* b. Time between initial diagnostic biopsies and randomization \> 4 months, or radiation therapy initiation \> 6 months
* c. Cribriform or Intraductal histologic components
* d. Gleason Score ≥7 (3+4)-ISUP Grade 2 biopsy outside the intent to treat PZ
* e. Multicentric pathologic MRI (PIRADS ≥4) outside a same PZ
* f. Initial PSA \> 20 ng/ml
* g. Regional pathologic nodes or metastases
* h. Androgen-deprivation therapy
* i. Any cancer within the last 5 years except skin basocellular carcinoma or any uncontrolled cancer
* j. Urethral stenosis
* k. Recurrent prostatitis (at least 3 episodes within the last 3 years)
* l. Any inflammatory collagen disease.
* m. Contraindication to repeated prostatic biopsies or MRI
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
50 Years
Study:
NCT07152067
Study Brief:
Protocol Section:
NCT07152067