Staging patients with newly diagnosed prostate cancer: A clinical trial comparing traditional scan types with an up-to-date specific scan type.

Phase 1

Conditions: ewly diagnosed prostate cancer, PET/CT scan used to stage newly diagnosed prostate cancer.
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Registration Number: EUCTR2021-000123-12-DK

Lead Sponsor: Odense University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Male

Target Recruitment: 448

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
Danish
• 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
o Suspicion of metastases as judged clinically
• Staging by imaging is warranted
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 298

Exclusion Criteria

• Consent not given
• Inability to read and/or understand provided patient information in
Danish
• Previously given consent to this study withdrawn for any reason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