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 @ 10:09 PM
Ignite Modification Date:
2025-12-24 @ 10:09 PM
NCT ID:
NCT07260435
Eligibility Criteria:
Inclusion Criteria:
* Male and ≥18 years of age
* Capable of understanding and complying with protocol requirements and able to understand and sign the informed consent form
* Histological diagnosis of prostate adenocarcinoma
* Low volume de novo metastatic disease (M1a or M1b) defined as anything other than fitting the criteria for high-volume metastatic disease, e.g., four or more bone lesions with one or more lesions in any body structure beyond the spine or pelvis, or visceral disease (non-nodal). This has been assessed by either bone scan and computed tomography (CT), or PSMA-PET scan. Low-volume disease has subsequently been confirmed by the local (multidisciplinary) team after consideration of the available imaging results as per the standard imaging protocol for the site.
* ADT initiated within 6 weeks prior to inclusion
* Eastern Cooperative Oncology Group (ECOG) performance scale status of 0, 1 or 2
* Fit for treatment with apalutamide or enzalutamide according to treating physician
Exclusion Criteria:
* Pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of the prostate
* Other prior malignancy less than or equal to 5 years prior to randomization except for squamous or basal cell skin carcinoma or non-invasive superficial bladder cancer
* History of seizures or medications known to lower seizure threshold
* Any other prior treatment for prostate cancer other than ADT (e.g., other next generation anti-androgens or other CYP17 inhibitors, chemotherapy, immunotherapy, or radiopharmaceutical agents)
* ADT started more than 6 weeks before inclusion
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT07260435
Study Brief:
Protocol Section:
NCT07260435