Back to Search Results- Terminated
- Diagnostic
- Interventional
- Randomized
- Diagnostic Test
- Odense University Hospital
- 18 Years -
Study Purpose
Early and correct diagnostic staging is paramount to keep patients with newly diagnosed prostate cancer in the correct treatment tract to avoid under- and overdiagnosis in prostate cancer staging. With accurate staging, the investigators aim to save patients from side effects of insufficient or too extensive treatment. The investigators hypothesize that precise staging will lead to optimized individualized treatment and subsequently to prolonged survival and increased quality of life. Prostate cancer is a very heterogeneous disease varying from indolent tumors to aggressive cancer types. About one-fifth of patients with newly detected high- or intermediate-risk prostate cancer present with bone metastases and their 3-years survival is less than 50%. Precise staging is required for planning relevant treatment that has the potential to increase survival. The prostate-specific membrane antigen (PSMA) is overexpressed in prostate cancer cells and can serve as a target for precise diagnosis and staging. PSMA-positron emission tomography/computed tomography (PET/CT) has shown to be more accurate than traditional imaging, but there is a need for prospective trials analyzing the impact of primary staging with PSMA-PET/CT on treatment planning and patient benefit. In a prospective multicenter study, the investigators plan to include 448 patients and randomize 1:1 to either traditional imaging or PSMA-PET/CT. The investigators aim to analyze whether PSMA-PET/CT increases progression-free survival and quality of life. Further, the investigators aim to validate the accuracy of primary staging with PSMA-PET/CT compared with conventional imaging.
Intervention
Diagnostic Test : 18F-PSMA-1007
Eligibility Requirements
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
Minimum age: 18
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
Recruiting status
Terminated
Estimated enrollment
385
Study start date
Oct 04, 2021
Study end date
Jan 30, 2025
Last updated
Mar 23, 2025
Primary purpose
Diagnostic
Design
Interventional
Intervention
Diagnostic Test
Study phase
NA
Allocation
Randomized
Sponsor:
Odense University Hospital
Collaborator:
Sygehus Lillebaelt
Esbjerg Hospital - University Hospital of Southern Denmark
Investigator:
N/A
Publications
Websites
NORDCAN: Cancer Incidence, Mortality, Prevalence and Survival, accessed 2018/09/09
NCT05123300
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