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 @ 12:49 PM
Ignite Modification Date:
2025-12-24 @ 12:49 PM
NCT ID:
NCT04742361
Eligibility Criteria:
Inclusion Criteria:
* Male with original diagnosis of adenocarcinoma of the prostate with prior definitive therapy
* Suspicion of recurrence or persistence
* after radiotherapy or cryotherapy: 3 consecutive PSA rises and/or PSA rise by 2.0 ng/mL or more above nadir (ASTRO-Phoenix)
* after prostatectomy, PSA \> 0.2 ng/mL on 2 or more determinations (recurrence), or failure of PSA to fall to undetectable levels post-prostatectomy (persistence) (American Urological Association)
* For patients who previously had radical prostatectomy, salvage radiotherapy is one likely treatment plan; for patients who initially underwent radiotherapy (including brachytherapy), confirmation of low volume disease is needed to define (local) treatment.
* Life expectancy of 6 months or more as judged by the investigator
* Willing and able to undergo all study procedures
* Informed consent in writing
Exclusion Criteria:
* Age: less than18 years
* Contraindications to any of the ingredients of \[18F\]PSMA-1007
* Close affiliation with the investigational site
* At the time of enrolment into this study, participating in another therapeutic clinical trial or has completed study participation in another therapeutic clinical trial within 5 days of enrolment into this trial
* Having been previously enrolled in this clinical trial
* Mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial
* Being clinically unstable or requiring emergency treatment
* Patients who are unwilling to consider a biopsy if clinically recommended
* Patients who are unable to undergo a PET/CT scan
* Patients for whom systemic therapy is the most likely course regardless of PET findings.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT04742361
Study Brief:
Protocol Section:
NCT04742361