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 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT07038304
Eligibility Criteria:
Inclusion Criteria:
* Adenocarcinoma of the prostate.
* mCRPC setting, with testosterone level \< 50 ng/dl or 1.7 nmol/l.
* Oligoprogressive disease diagnosed on PSMAscan; defined as the progression of pre-existing metastatic disease, and/or the appearance of new metastases and/or the appearance of a local relapse with a maximum of 3 lesions in total.
* Patients currently treated with ADT, whether combined with another systemic treatment such as ARTA, chemotherapy.
* For patients treated with chemotherapy, the course should be completed or stopped before start MORT - In case of treatment with ARTA, a minimal of 3 months response (PSA or clinical response).
* WHO performance status 0-2.
* Age \> = 18 years old.
* Patiënt should be presented at the multidisciplinary tumor board of the local hospital in which the therapy will be given.
* Before patiënt registration, written informed consent must be given according to ICH/GCO and national/local regulations.
Exclusion Criteria:
* Serum testosterone level \> 50 ng/ml or \> 1.7 nmol/l.
* Presence of more than 3 progressive/new metastatic lesions and/or local recurrence (which counts for 1 lesion).
* Active malignancy other than prostate cancer that can potentially interfere with the interpretation of the trial, except non-melanoma skin cancer or non-invasive urothelial cell carcinoma.
* Local recurrence in the prostate after previous radiotherapy
* Previous treatments (RT, surgery) or comorbidities making new treatment with MDRT impossible.
* Disorder precluding understanding of trial Information or informed consent or signing informed consent.
* Evidence of PSMA-negative disease.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT07038304
Study Brief:
Protocol Section:
NCT07038304