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 @ 10:19 PM
Ignite Modification Date:
2025-12-24 @ 10:19 PM
NCT ID:
NCT03075735
Eligibility Criteria:
Inclusion Criteria:
1. Provision of signed informed consent.
2. Patients must be ≥18 years old.
3. Histologically confirmed prostate cancer
4. presence of metastatic disease according to Bone-, CT- and/or MRI-scan.
5. Confirmed castration resistant prostate cancer defined as disease progression despite castrate levels of testosterone (\<0.5ng/mL) and either a continuous rise in the serum prostate-specific antigen (PSA) levels, the progression of preexisting disease and /or the appearance of new metastases. Patients must be maintained on aLHRH or have underwent bilateral orchiectomy.
6. Eligible patients are due to start or have started first-line treatment with any approved survival-prolonging therapy for mCRPC within a period of 6 months from study entry.
7. ECOG performance status ≤21.
8. Unknown mutation carrier status at the study entry.
Exclusion Criteria:
1. Previous cancer diagnosis, except those patients who had a localized malignant tumour and who are five years cancer-free or those diagnosed with skin cancers (of non-melanoma type) or excised in situ carcinomas.
2. Any prior medical history that according to the judgement of the investigator might interfere with the subject´s granting of informed consent or the safe execution of the procedures required in the study.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT03075735
Study Brief:
Protocol Section:
NCT03075735