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 @ 5:19 AM
Ignite Modification Date:
2025-12-25 @ 5:19 AM
NCT ID:
NCT04642027
Eligibility Criteria:
Inclusion Criteria:
* Patients with prostate adenocarcinoma treated with radical prostatectomy;
* Tumour stage pT2-4, R0-1, pN0, or cN0, cNx according to the UICC TNM 2009, only with Gleason score available;
* No lymph node or distant metastases. A recent PSMA-PET scan (\< 60 days) without evidence of lymph node or distant metastases;
* PSA progression after prostatectomy defined as two consecutive rises with the final PSA \> 0.1 ng/mL or 3 consecutive rises. The first value must be measured at least 6 weeks after radical prostatectomy;
* PSA at inclusion \< 1.0 ng/mL;
* WHO performance status 0-2 at inclusion;
* Age at inclusion between 18 and 80 years;
* Written (signed and dated) informed consent prior to registration.
Exclusion Criteria:
* Prior pelvic irradiation, (chemo)hormonal therapy or orchiectomy;
* Previous or concurrent active invasive cancers other than superficial non-melanoma skin cancers;
* Patients with positive nodes or with distant metastases based on the surgical specimen of lymphadenectomy or the following minimum diagnostic workup: PSMA-PET/CT scan, 60 days prior to registration;
* Double-sided metallic hip prosthesis;
* Inability or unwillingness to understand the information on trial-related topics, to give informed consent or to fill out QoL questionnaires.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04642027
Study Brief:
Protocol Section:
NCT04642027