EUCTR2012-005431-86-NL
Active, not recruiting
Not Applicable
Evaluation of 18F-FDHT PET/CT as an early treatment response marker in patients with metastasized castration-resistant prostate cancer to be treated with enzalutamide. - 18F-FDHT PET/CT as an early Treatment Response marker
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Castration-resistant prostate cancer
- Sponsor
- niversity Medical Center Groningen
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age 50 or older.
- •2\. Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features.
- •3\. Ongoing androgen deprivation therapy with a gonadotropin\-releasing hormone analogue or bilateral orchidectomy.
- •4\. Progressive disease despite androgen deprivation therapy as defined by rising PSA levels or progressive soft tissue or bone disease.
- •5\. Metastatic disease documented by bone lesions on bone scan or by measurable soft tissue disease by CT
- •6\. No prior cytotoxic chemotherapy for prostate cancer.
- •7\. Asymptomatic or mildly symptomatic from prostate cancer
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •1\. Severe concurrent disease, infection, or co\-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollment.
- •2\. Known or suspected brain metastasis or active leptomeningeal disease.
- •3\. History of another malignancy within the previous 5 years other than curatively treated non\-melanomatous skin cancer.
Outcomes
Primary Outcomes
Not specified
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