Comparison of two new PET/CT-scanning methods for the detection of metastases in prostate cancer.

68Ga-PSMA PET/CT vs. 18F-PSMA PET/CT for the diagnosis of metastases in newly diagnosed high-risk prostate cancer patients undergoing radical prostatectomy - PSMA-Px

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-004846-39-DK

Enrollment

Registered

2021-10-04

Start date

2023-04-26

Completion date

Unknown

Last updated

2024-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer MedDRA version: 20.0 Level: LLT Classification code 10036910 Term: Prostate cancer NOS System Organ Class: 100000004864 MedDRA version: 21.1 Level: LLT Classification code 10065410 Term: Combined positron emission tomogram and computerized tomogram System Organ Class: 100000004848

Interventions

Product Name: 18F-FPSMA-1007 Product Code: 2021043738 Pharmaceutical Form: Injection INN or Proposed INN: [18F]F-PSMA-1007 Other descriptive name: F-18-PSMA-1007 Concentration unit: MBq megabecquerel(

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: High risk prostate cancer (defined as PSA>20 or cT2c or ISUP grade 4-5 (Gleason score 8-10)) according to EAU guidelines. 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 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25

Exclusion criteria

Exclusion criteria: • Prior or current therapy for prostate cancer. • History of another malignancy within the previous 5 years other than curatively treated non-melanoma skin cancer • History of allergic reactions attributed to compounds of the 68Ga-PSMA or 18F-PSMA radiotracers • Subjects with severe claustrophobia unresponsive to oral anxiolytics • Subjects weighing more than 180 kilograms (weight limit for scanner table), or unable to fit within the imaging gantry • Subjects with any medical condition or other circumstances that, in the opinion of the Investigator, would significantly decrease the reliability of data, achievement of study objectives or completing the study

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary purpose of this study is to compare the diagnostic properties by the two PSMA-ligands (18F-PSMA PET/CT vs 68Ga-PSMA PET/CT) in patients undergoing radical prostatectomy. ;Secondary Objective: Secondary purposes is; to investigate the added value of PSMA PET/CT in patients with standard imaging.;Primary end point(s): Primary end point is difference between diagnostic properties (Sensitivity, specificity, PPV, NPV, and accuracy) by the two PSMA-ligands for staging of high risk prostate cancer.;Timepoint(s) of evaluation of this end point: End of study	—

Measure

Time frame

Main Objective: The primary purpose of this study is to compare the diagnostic properties by the two PSMA-ligands (18F-PSMA PET/CT vs 68Ga-PSMA PET/CT) in patients undergoing radical prostatectomy. ;Secondary Objective: Secondary purposes is; to investigate the added value of PSMA PET/CT in patients with standard imaging.;Primary end point(s): Primary end point is difference between diagnostic properties (Sensitivity, specificity, PPV, NPV, and accuracy) by the two PSMA-ligands for staging of high risk prostate cancer.;Timepoint(s) of evaluation of this end point: End of study

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary end point is impact of PSMA PET/CT on detection of additional metastases compared to standard imaging.;Timepoint(s) of evaluation of this end point: End of study	—

Countries

Denmark

Contacts

Public ContactDepartment of Nuclear Medicine

Aalborg University Hospital

f.gossili@rn.dk004597665500

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026