EUCTR2021-000123-12-DK
Active, Not Recruiting
Phase 1
PRISMA-PET – Primary Staging of Prostate Cancer: A Randomized Controlled Trial Comparing 18F-PSMA-1007 PET/CT to Conventional Imaging. - PRISMA-PET
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Odense University Hospital
- Enrollment
- 448
- Status
- Active, Not Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Men with a newly diagnosed intermediate or high risk (including locally advanced) prostate cancer or low risk with a clinical suspicion of
- •metastases based on other findings, and before any treatment is initiated.
- •Has given informed consent to participate
- •Can read and understand provided patient information material in
- •Biopsy verified, newly diagnosed and untreated PCa
- •Any, some, or all of the following features:
- •o PSA \= 20 ng/ml OR
- •o Gleason Score \= 4\+3 OR
- •o Tumor stage cT2c or above as determined by digital rectal exploration
- •and/or transrectal ultrasonography OR
Exclusion Criteria
- •Consent not given
- •Inability to read and/or understand provided patient information in
- •Previously given consent to this study withdrawn for any reason
- •Staging by imaging not warranted as judged clinically
- •Allergy towards NaF, PSMA or other contents in the solutions
Outcomes
Primary Outcomes
Not specified
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