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This is a multicenter observational (cohort) study that follows the course of disease in patients with metastatic castration-resistant prostate cancer. It was open to men aged 18 and over who were starting or about to start first-line treatment. It was conducted as an observational study with no assigned phase and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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.