PSMA-PET/CT for prostate cancer

Phase 1

• Conditions: prostate cancer (and metastases); Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2017-003461-96-BE
• Lead Sponsor: Ghent University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-30
• Last Update Posted: 18 March 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 72

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 14
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 58

Exclusion Criteria

- Age < 40 or > 70 years in phase-1; age <18 years in phase-2 trial
- Physically or mentally unfit to perform the sequential procedures
- Refusal of patient to be informed about accidental findings on scans
- Patients with heart failure if ejection fraction < 45% (phase 2 trial)
- History of anaphylactic shock after administration of Visipaque CT contrast (phase 2 trial)

Study & Design

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