[18F]-labelled FDHT in PET/CT for detection and staging of bone metastases in hormone naïve prostate cancer
Completed
- Conditions
- metastasisprostate cancer1002747610036958
- Registration Number
- NL-OMON39807
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
Men, fifty years or older, with metastasized prostate cancer, confirmed by positive bone scan, suspicious lesions >=2 in bone, who have not been treated with androgen deprivation therapy yet. The men cannot have another malignancy and they have to have given informed consent.
Exclusion Criteria
• active cancer besides prostate cancer
• no written informed consent
• previous androgen deprivation therapy
• Age below 50
• imminent pathological fractures or spinal cord lesions as a result of metastases that reqiure immediate start of androgen deprivation therapy
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>First phase endpoint is the first [18F]FDHT PET. Lesions seen on this scan<br /><br>will be compared with those seen of bone scintigraphy, MRI and/or CT. SUV will<br /><br>be used to quantify uptake of [18F]FDHT PET in the lesions.<br /><br>Second phase endpoint is the second [18F]FDHT PET. Again, SUV in the lesions<br /><br>will be calculated and compared - reduction in both number of lesions, and<br /><br>uptake per lesion- with those seen on the first scan. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Prostate Specific Antigen, Gleason Sum Score in relation to SUV differences<br /><br>between the first and the second [18F]FDHT PET</p><br>