Detection and staging of bone metastases in prostate cancer, not yet been treated with hormones, using labelled testosterone in PET/CT.

Conditions: Hormone naive prostate cancer, metastasized to bone (2 or more bone metastases).
Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

Registration Number: EUCTR2013-002415-10-NL

Lead Sponsor: niversity Medical Center Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Male

Target Recruitment: Not specified

Inclusion Criteria

•metastasized prostate cancer, =2 lesions in bone, onfirmed by visible lesions on bone scan, CT and/or MRI consistent with disease
•no other known malignancies
•no previous androgen deprivation therapy
•informed consent

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 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

•active cancer besides prostate cancer
•previous androgen deprivation therapy
•no informed consent
•imminent pathological fractures or spinal cord lesions as a result of metastases that require immediate start of androgen deprivation therapy

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: The secondary objective is to determine differences in uptake in lesions using [18F]FDHT PET/CT three months after start of androgen deprivation therapy. Also if there is relation between uptake in lesions and Glasgow Sum Score and PSA (both routinely obtained);Primary end point(s): Second [18F]-FDHT PET.;Timepoint(s) of evaluation of this end point: 3 months after first [18F]-FDHT PET (approximately 4 months after inclusion).;Main Objective: The primary objective of this study is to determine the feasibility of [18F]FDHT PET/CT for in vivo evaluation of bone metastases in prostate cancer. Active locations will be compared with those seen on conventional imaging (bone scintigraphy, CT and/or MRI)<br><br>

Secondary Outcome Measures