[18F]PSMA-11 PET/CT for prostate cancer – phase 3 clinical trial

Phase 1

• Conditions: prostate cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-003168-29-BE
• Lead Sponsor: Ghent University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-11
• Last Update Posted: 17 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 96

Inclusion Criteria

Patients diagnosed with prostate cancer, either in the setting of diagnosis of biochemical recurrence after previous treatment, or at primary diagnosis and staging
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 19
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 77

Exclusion Criteria

- Age < 18 years
- Physically or mentally unfit to perform the sequential procedures
- Refusal of patient to be informed about accidental findings on scans
- History of anaphylactic shock after administration of Visipaque CT contrast
- Serum creatinine concentration > 2.0 mg/dl and/or estimated glomerular filtration rate < 60 ml/min

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified