Evaluating the feasibility and accuracy of novel intra-operative molecular imaging with two PSMA-tracers in prostate cancer
- Conditions
- C61Malignant neoplasm of prostate
- Registration Number
- DRKS00020942
- Lead Sponsor
- Klinik und Poliklinik für Urologie, Kinderurologie und Uroonkologie Universitätsklinikum Essen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 40
• Male = 18 years of age
• Histologically confirmed adenocarcinoma of the prostate
• High-risk for positive surgical margins
a. cT3 stage according to TNM classification, or
b. ISUP Gleason grade group 4/5, or
c. PSA >15 ng/ml
• Indication for radical prostatectomy
• Preoperative PCa staging performed according to current guidelines
• Known hypersensitivity to the diagnostic PET agent or its components
• Administration of any kind of PET tracer within a period corresponding to 8 half-lives of the respective radionuclide
• Subjects not able to declare meaningful informed consent on their own (e.g. with legal guardian for mental disorders)
• Evidence of neuroendocrine small cell prostate cancer
• Polytope metastases on conventional imaging as per CHAARTED criteria (visceral metastases or =4 bone metastases including at least one outside the axial skeleton)
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method