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.

• Conditions: Castration-resistant prostate cancer; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2012-005431-86-NL
• Lead Sponsor: niversity Medical Center Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-18
• Last Update Posted: 10 March 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: Not specified

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
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary objective is to evaluate 18F-FDHTPET/CT as an early treatment response marker in patients with metastasized CRPC to be treated with enzalutamide. ;Secondary Objective: Secondary objective is to collect biopsies of prostate cancer bone and/or lymph node metastases, blood and urine specimens for future research. ;Primary end point(s): Association of 18F-FDHT PET/CT prior to start of enzalutamide (study week 1) with treatment response. <br>Association of delta (study week 1 and 5) 18F-FDHT PET/CT with treatment response. ;Timepoint(s) of evaluation of this end point: See above E.5.1.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Collection and storage of biomaterial for future research.;Timepoint(s) of evaluation of this end point: Prior to start of enzalutamide (study week 1) and after 12 weeks of treatment (study week 13)