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:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-24 @ 7:07 PM
NCT ID:
NCT03604757
Eligibility Criteria:
Inclusion criteria :
24 patients divided in :
* 6 patients with low risk prostate cancer (Gleason score ≤ 6 and cT1-T2a and Prostate Specific Antigen (PSA) value \< 10 ng/mL)
* 12 patients with intermediate risk prostate cancer (Gleason score 7 or cT2b or PSA value 10-20 ng/mL) divided in : 6 patients who are Gleason score 7(3+4) (favourable intermediate risk) 6 patients who are Gleason score 7(4+3) (unfavourable intermediate risk)
* 6 patients with high risk prostate cancer (Gleason \> 7 or cT2c or PSA value \> 20 ng/mL)
* Candidate for radical prostatectomy after discussion in multidisciplinary committee
* Covered by the national health insurance system
* Written informed consent willingly obtained
Exclusion criteria :
* any kind of previous treatment for prostate cancer (hormonal treatment, EBRT, brachytherapy, cryotherapy, etc…);
* patient not candidate for radical prostatectomy and/or unable to benefit from surgery
* freedom deprivated patient by judiciary or administrative decision
* patient under legal protection or unable to express its own consent
* patient within exclusion period from another clinical trial
* known contraindication to radiopharmaceuticals and / or excipients
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT03604757
Study Brief:
Protocol Section:
NCT03604757