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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-003168-29-BE

Enrollment

Registered

2019-02-11

Start date

2019-03-15

Completion date

Unknown

Last updated

2021-03-17

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

Conditions

prostate cancer

Interventions

Product Name: [18F]PSMA-11 Pharmaceutical Form: Solution for injection INN or Proposed INN: [18F]PSMA-11 Other descriptive name: [18F]AlF-HBED-CC-PSMA Concentration unit: GBq/ml gigabecquerel/millilit

Eligibility

Sex/Gender

Male

Inclusion criteria

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

Exclusion criteria: - Age 2.0 mg/dl and/or estimated glomerular filtration rate < 60 ml/min

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the position of [18F]PSMA-11 PET/CT within the field of available radiotracers for diagnosis of prostate cancer. For this, the diagnostic performances of [18F]PSMA-11 will be compared to those of the current state-of-the-art radiotracer [68Ga]PSMA-11.;Secondary Objective: Not applicable;Primary end point(s): 1) Evaluation of the non-inferiority of [18F]PSMA-11 compared to [68Ga]PSMA-11 with respect to the number of positive PET scans;Timepoint(s) of evaluation of this end point: for primary end point 1: 0 to 100 minutes post injection for both [18F]PSMA-11 and [68Ga]PSMA-11	—

Measure

Time frame

Main Objective: To determine the position of [18F]PSMA-11 PET/CT within the field of available radiotracers for diagnosis of prostate cancer. For this, the diagnostic performances of [18F]PSMA-11 will be compared to those of the current state-of-the-art radiotracer [68Ga]PSMA-11.;Secondary Objective: Not applicable;Primary end point(s): 1) Evaluation of the non-inferiority of [18F]PSMA-11 compared to [68Ga]PSMA-11 with respect to the number of positive PET scans;Timepoint(s) of evaluation of this end point: for primary end point 1: 0 to 100 minutes post injection for both [18F]PSMA-11 and [68Ga]PSMA-11

—

Secondary

Measure	Time frame
Secondary end point(s): 1) Evaluation of the superiority of [18F]PSMA-11 compared to [68Ga]PSMA-11 with respect to the number of positive PET scans 2) Evaluation of the superiority of [18F]PSMA-11 compared to [68Ga]PSMA-11 with respect to the total number of suspected prostate cancer lesions in corresponding ([68Ga]PSMA-11 vs [18F]PSMA-11) scans 3) Evaluation of the superiority of [18F]PSMA-11 compared to [68Ga]PSMA-11 with respect to the scoring of corresponding ([68Ga]PSMA-11 vs [18F]PSMA-11) suspected lesions 4) Descriptive evaluation of [18F]PSMA-11 compared to [68Ga]PSMA-11 with respect to: a) the number of positive PET scans; b) the total number of suspected prostate cancer lesions in corresponding ([68Ga]PSMA-11 vs [18F]PSMA-11) scans; c) the scoring of corresponding ([68Ga]PSMA-11 vs [18F]PSMA-11) suspected lesions 5) Evaluation of the diagnostic specificity of [18F]PSMA-11 compared to [68Ga]PSMA-11 6) Evaluation of the safety of [18F]PSMA-11 administration;Timepoint(s) of evaluation of this end point: for secondary end points 1, 2, 3, 4 and 6: 0 to 100 minutes post injection for both [18F]PSMA-11 and [68Ga]PSMA-11 for secondary end point 5: 0 to 180 days post [18F]PSMA-11 and [68Ga]PSMA-11 administration	—

Measure

Time frame

Secondary end point(s): 1) Evaluation of the superiority of [18F]PSMA-11 compared to [68Ga]PSMA-11 with respect to the number of positive PET scans 2) Evaluation of the superiority of [18F]PSMA-11 compared to [68Ga]PSMA-11 with respect to the total number of suspected prostate cancer lesions in corresponding ([68Ga]PSMA-11 vs [18F]PSMA-11) scans 3) Evaluation of the superiority of [18F]PSMA-11 compared to [68Ga]PSMA-11 with respect to the scoring of corresponding ([68Ga]PSMA-11 vs [18F]PSMA-11) suspected lesions 4) Descriptive evaluation of [18F]PSMA-11 compared to [68Ga]PSMA-11 with respect to: a) the number of positive PET scans; b) the total number of suspected prostate cancer lesions in corresponding ([68Ga]PSMA-11 vs [18F]PSMA-11) scans; c) the scoring of corresponding ([68Ga]PSMA-11 vs [18F]PSMA-11) suspected lesions 5) Evaluation of the diagnostic specificity of [18F]PSMA-11 compared to [68Ga]PSMA-11 6) Evaluation of the safety of [18F]PSMA-11 administration;Timepoint(s) of evaluation of this end point: for secondary end points 1, 2, 3, 4 and 6: 0 to 100 minutes post injection for both [18F]PSMA-11 and [68Ga]PSMA-11 for secondary end point 5: 0 to 180 days post [18F]PSMA-11 and [68Ga]PSMA-11 administration

—

Countries

Belgium

Contacts

Public ContactHIRUZ

Ghent University Hospital

hiruz.ctu@uzgent.be+329332 05 00

Outcome results

None listed

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