A clinical study on 18F-PSMA-1007 PET/CT scans in patients with recurrent prostate cancer and in chronic prostate cancer

Recurrent and Metastatic Prostate Cancer: Impact of 18F-PSMA-1007 PET/CT on clinical decision making and response monitoring - RE-PRISMA

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000184-78-DK

Enrollment

Registered

2021-05-07

Start date

2021-06-21

Completion date

Unknown

Last updated

2024-10-28

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

Conditions

Metastatic Prostate Cancer MedDRA version: 21.1 Level: LLT Classification code 10076506 Term: Castration-resistant prostate cancer System Organ Class: 100000004864

Interventions

Product Name: Fluor-18-Prostate Specific Antigen (F18-PSMA) Product Code: 27416229619 Pharmaceutical Form: Solution for infusion INN or Proposed INN: F-18-PSMA-1007 Other descriptive name: F-18-PSMA-1

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: • Has given informed consent to participate • Minimum age 18 years • Can understand provided patient information material in Danish • Verified metastatic castration resistant prostate cancer both clinically and by imaging, all degrees of dissemination included • Life expectancy more than 3 months 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: • Serious medical conditions preventing treatment for prostate cancer • Psychiatric diagnosis, or other circumstances where the will or ability to perform the planned imaging and investigations is questionable • Known allergy for the PSMA tracer or other contents in the solution

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of this project is to evaluate 18F-labelled PSMA-PET/CT imaging for response prediction and monitoring in metastatic prostate cancer;Secondary Objective: To assess the feasibility of the imaging evaluation tool "PET Response Criteria in Solid Tumors" (PSMA-PERCIST);Primary end point(s): Diagnostic accuracy and first detection of progression - conventional imaging compared with 18F-PSMA-PET/CT and whole body MRI (WB MRI) scans;Timepoint(s) of evaluation of this end point: Last included patients last visit	—

Measure

Time frame

Main Objective: The aim of this project is to evaluate 18F-labelled PSMA-PET/CT imaging for response prediction and monitoring in metastatic prostate cancer;Secondary Objective: To assess the feasibility of the imaging evaluation tool "PET Response Criteria in Solid Tumors" (PSMA-PERCIST);Primary end point(s): Diagnostic accuracy and first detection of progression - conventional imaging compared with 18F-PSMA-PET/CT and whole body MRI (WB MRI) scans;Timepoint(s) of evaluation of this end point: Last included patients last visit

—

Secondary

Measure	Time frame
Secondary end point(s): Compare the imaging evaluation tools "RECIST" with "PSMA-PERCIST" in detection of first progression;Timepoint(s) of evaluation of this end point: Last included patients last visit	—

Countries

Denmark

Contacts

Public ContactDepartment of Nuclear Medicine

Odense University Hospital

Malene.Grubbe.Hildebrandt@rsyd.dk004530171888

Outcome results

None listed

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