prostate cancer (and metastases)
Conditions
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 gigabecquerel(s)
Concen
Sponsors
Ghent University Hospital
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 14 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 58
Exclusion criteria
Exclusion criteria: - Age 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Phase 1: The primary objective is to establish the safe administration and biodistribution of intravenous [18F]-PSMA-11; occurrence of adverse events according to common toxicity criteria. Phase 2: - Evaluation of effective targeting of prostate cancer and eventual metastases with [18F]PSMA-11: visual and/or semi-quantitative (SUV) analysis - Determination of the optimal scan protocol: time of scanning, duration of scan, optimal radioactivity dose (2.0 ± 0.2 vs 4.0 ± 0.4 MBq/kg body weight) Extension: evaluation of the added value of furosemide (to improve diuresis), as part of the standard scanprotocol;Main Objective: The main objective is the demonstration of the safety, radiation dosimetry and efficacy of [18F]-PSMA-11 PET/CT. Phase 1: The primary objective is to establish the safe administration and biodistribution of intravenous [18F]-PSMA-11; occurrence of adverse events according to common toxicity criteria. Phase 2: - Evaluation of effective targeting of prostate cancer and eventual metastases with [18F]PSMA-11: visual and/or semi-quantitative (SUV) analysis - Determination of the optimal scan protocol: time of scanning, duration of scan, optimal radioactivity dose (2.0 ± 0.2 vs 4.0 ± 0.4 MBq/kg body weight) Extension: evaluation of the added value of furosemide (to improve diuresis), as part of the standard scanprotocol;Secondary Objective: Phase 1: Secondary endpoints are the organ dosimetry and establishment of critical organs (mGy/MBq), the total body effective dose (mSV/MBq), description of the kinetics of the radioligand and the occurrence of metabolites in plasma and urine. Phase 2: - Evaluation of the inter-observer difference for interpretation of [18F]PSMA-11 scans - Evaluation of the diagnostic specificity of [18F]PSMA-11 - Evaluation of the impact of the [18F]PSMA-11 scan on the choice of therapy.;Timepoint(s) of evaluation of this end point: 0-24 hours post-administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Phase 1: Secondary endpoints are the organ dosimetry and establishment of critical organs (mGy/MBq), the total body effective dose (mSV/MBq), description of the kinetics of the radioligand and the occurrence of metabolites in plasma and urine. Phase 2: - Evaluation of the inter-observer difference for interpretation of [18F]PSMA-11 scans - Evaluation of the diagnostic specificity of [18F]PSMA-11 - Evaluation of the impact of the [18F]PSMA-11 scan on the choice of therapy.;Timepoint(s) of evaluation of this end point: 0-60 days post [18F]PSMA-11 injection | — |
Countries
Belgium
Contacts
Public ContactBimetra Clinics
Ghent University Hospital
Outcome results
None listed