PRISMA-PET - Primary Staging of Prostate Cancer With PSMA
Launched by ODENSE UNIVERSITY HOSPITAL · Nov 5, 2021
Trial Information
Current as of July 21, 2025
Terminated
Keywords
ClinConnect Summary
The PRISMA-PET trial is studying how a special imaging test called PSMA-PET/CT can help doctors better stage (or determine the extent of) prostate cancer in men. Staging is crucial because it helps ensure that patients receive the right amount and type of treatment, which can improve survival rates and quality of life. The trial aims to compare this new imaging method with traditional imaging techniques to see if PSMA-PET/CT provides more accurate results and leads to better treatment outcomes.
To participate in this trial, men aged 65 to 74 who have been diagnosed with prostate cancer and have certain risk factors may be eligible. Participants will be randomly assigned to receive either traditional imaging or the PSMA-PET/CT scan. Throughout the study, researchers will monitor how well the new imaging method works and whether it helps patients live longer, healthier lives. It's important to note that all participants must be able to read and understand the information provided in Danish and must give their consent to join the study.
Gender
MALE
Eligibility criteria
- Inclusion Criteria:
- • Has given informed consent to participate
- • Can read and understand provided patient information material in Danish
- • Biopsy verified PCa
- * Any, some, or all of the following features:
- • Prostatic Specific Antigen (PSA) ≥ 20 ng/ml OR
- • Gleason Score ≥ 4+3 OR
- • Tumor stage clinically judged T2c cancer (cT2c) or above as determined by digital rectal exploration and/or transrectal ultrasonography
- • Suspicion of metastases clinically based on other findings
- • Prostatic Specific Antigen (PSA) ≤ 200 ng/ml
- • Staging by imaging warranted
- Exclusion Criteria:
- • Consent not given
- • Inability to read and/or understand provided patient information in Danish
- • Previously given consent but withdrawn for any reason
- • Staging by imaging not warranted as judged clinically
- • Allergy towards contents in the tracer solution
About Odense University Hospital
Odense University Hospital is a leading academic medical center located in Denmark, dedicated to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, the hospital is committed to enhancing patient outcomes and fostering collaboration among multidisciplinary teams. With a focus on translating scientific discoveries into practical applications, Odense University Hospital leverages its state-of-the-art facilities and expertise to conduct rigorous trials across various medical fields, ensuring adherence to the highest ethical and regulatory standards. Through these efforts, the hospital aims to contribute significantly to the global body of medical knowledge and improve the quality of care for patients both locally and internationally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Esbjerg, , Denmark
Odense, , Denmark
Vejle, , Denmark
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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