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 @ 12:46 PM
Ignite Modification Date:
2025-12-24 @ 12:46 PM
NCT ID:
NCT04279561
Eligibility Criteria:
Inclusion Criteria:
* Histologically proven prostate cancer
* Know metastatic disease on previous imaging, or PSA value ⩾ 1 ng/ml;
* Castration resistant disease with confirmed testosterone level =\< 50 ng/ml under prior first-line androgen deprivation therapy (ADT)
* New planned treatment with enzalutamide or abiraterone, darolutamide or apalutamide
* Willingness to undergo ARSI throughout the duration of the study as prescribed by the treating uro-oncologist
* Stated willingness to comply with continuation of ARSI treatment for the duration of the study
* Provision of signed and dated informed consent form
Exclusion Criteria:
* Inability to provide written informed consent
* Known inability to remain still and lie flat for duration of each imaging procedure (about 30 minutes)
* Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy
* A baseline superscan pattern on bone scan
* Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, patients with a prior history of malignancy that has been adequately treated and who have been disease free for more than 3 years are eligible
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT04279561
Study Brief:
Protocol Section:
NCT04279561