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 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT06982469
Eligibility Criteria:
Inclusion Criteria:
* Patients with increasing PSA after RP and clinical evidence of PET PSMA/Choline+ and MRI+ isolated prostatic bed relapse (IPBR) that is implantable via transperineal route . The IPBR should be visible on TRUS imaging to allow proper implant placement.
* Pathological confirmation is advised in all cases but it is not mandatory .
* Brachytherapy MRI-based dosimetry
* Patient written Informed Consent of the Institutional Review Board-approved protocol that discloses the investigational nature of the treatment as well as the available standard treatment options.
Exclusion Criteria:
* Distant Metastases
* Isolated nodal relapses
* Prior Irradiation to the IPBR area
* Multicentric IPBRs
* Life expectancy of less than 5 years or inability to tolerate and comply with an HDR procedure
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06982469
Study Brief:
Protocol Section:
NCT06982469