Primary localised prostate cancer, in men who opt for active treatment in the form of a radical prostatectomy
Conditions
Interventions
Product Name: [68Ga] PSMA-11
Pharmaceutical Form: Radiopharmaceutical precursor, solution
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: NA
Other descriptive name: 68GA-PSMA HBED-CC
Conc
Sponsors
University Medical Center Groningen
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • Male aged 18 years or older • Ability to provide signed informed consent and willingness to comply with protocol requirements. • Biopsy confirmed presence of adenocarcinoma of the prostate gland • Planned/already executed mpMRI (standard of care). • Planned for radical prostatectomy (standard of care). 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10 ;Inclusion criteria: • Male aged 18 years or older • Ability to provide signed informed consent and willingness to comply with protocol requirements. • Biopsy confirmed presence of adenocarcinoma of the prostate gland • Planned/already executed mpMRI (standard of care). • Planned for radical prostatectomy (standard of care). 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10 ;Inclusion criteria: • Male aged 18 years or older • Ability to provide signed informed consent and willingness to comply with protocol requirements. • Biopsy confirmed presence of adenocarcinoma of the prostate gland • Planned/already executed mpMRI (standard of care). • Planned for radical prostatectomy (standard of care). 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: • Have any medical condition or other circumstances that, in the opinion of the investigator, would significantly decrease obtaining reliable data, achieving study objectives, or completing the study. (part A and B) • Have a contraindication for mpMRI. (part A and B) • Will not undergo a radical prostatectomy. (part A and B) • Claustrophobia (part A and B) • Multiple malignancies (part A and B) • Anticoagulant therapy (part A) • Obese (>120 kg) (part A) • Have undergone a transurethral resection of prostate in the past (part A and B) ;Exclusion criteria: • Have any medical condition or other circumstances that, in the opinion of the investigator, would significantly decrease obtaining reliable data, achieving study objectives, or completing the study. (part A and B) • Have a contraindication for mpMRI. (part A and B) • Will not undergo a radical prostatectomy. (part A and B) • Claustrophobia (part A and B) • Multiple malignancies (part A and B) • Anticoagulant therapy (part A) • Obese (>120 kg) (part A) • Have undergone a transurethral resection of prostate in the past (part A and B) ;Exclusion criteria: • Have any medical condition or other circumstances that, in the opinion of the investigator, would significantly decrease obtaining reliable data, achieving study objectives, or completing the study. (part A and B) • Have a contraindication for mpMRI. (part A and B) • Will not undergo a radical prostatectomy. (part A and B) • Claustrophobia (part A and B) • Multiple malignancies (part A and B) • Anticoagulant therapy (part A) • Obese (>120 kg) (part A) • Have undergone a transurethral resection of prostate in the past (part A and B)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to determine the optimal pharmacokinetic model of 68Ga-PSMA PET/CT, so 68Ga-PSMA PET/CT results can be quantified in prostate cancer. ;Secondary Objective: The secondary objectives are to determine whether the optimal kinetic model of 68Ga-PSMA PET/CT is valid (by a repeatability test) and to see if 68Ga-PSMA PET/CT could be a feasible method to exactly localize the tumour within the prostate.;Primary end point(s): This study aims to determine the optimal kinetic model for 68Ga-PSMA uptake and to design a simplified quantitative model for tracer uptake (Part A).To establish the ideal timing of performing the whole body 68Ga-PSMA PET after administration of the radiotracer and to determine the optimal (quantitative) method for measuring 68Ga-PSMA uptake (Part A). To determine whether it is feasible to exactly identify and localize the tumour within the prostate (Part A and B). To study test-retest characteristics of 68Ga PSMA PET (Part B).;Timepoint(s) of evaluation of this end point: as soon as the first 8 patients have completed the study, the nuclear physicist will do the modelling, the model that is then tested is part B is analysed after the following 12 men have completed the study. ;Main Objective: The primary objective is to determine the optimal pharmacokinetic model of 68Ga-PSMA PET/CT, so 68Ga-PSMA PET/CT results can be quantified in prostate cancer. ;Secondary Objective: The secondary objectives are to determine whether the optimal kinetic model of 68Ga-PSMA PET/CT is valid (by a repeatability test) and to see if 68Ga-PSMA PET/CT could be a feasible method to exactly localize the tumour within the prostate.;Primary end point(s): This study aims to determine the optimal kinetic model for 68Ga-PSMA uptake and to design a simplified quantitative model for tracer uptake (Part A).To establish the ideal timing of performing the whole body 68Ga-PSMA PET after administration of the radiotracer and to determine the opti | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Furthermore, we want to determine the test-retest variability of the simplified quantitative model for 68Ga-PSMA that follows from part A (Part B). Secondary, we want to assess if 68Ga-PSMA PET/CT is able to localize and identify tumour tissue within the prostate, compared to mpMRI (Part A and B). - Quantify 68Ga-PSMA uptake kinetics in tumour lesions. - Comparison of 68Ga-PSMA PET (study visit) versus mpMRI (standard of care) regarding to tumour localization within the prostate;Timepoint(s) of evaluation of this end point: When all 20 men have completed the study and have undergone a radical prostatectomy, pathology will be compared to mpMRI and 68Ga-PSMA 11 PET/CT;Secondary end point(s): Furthermore, we want to determine the test-retest variability of the simplified quantitative model for 68Ga-PSMA that follows from part A (Part B). Secondary, we want to assess if 68Ga-PSMA PET/CT is able to localize and identify tumour tissue within the prostate, compared to mpMRI (Part A and B). - Quantify 68Ga-PSMA uptake kinetics in tumour lesions. - Comparison of 68Ga-PSMA PET (study visit) versus mpMRI (standard of care) regarding to tumour localization within the prostate;Timepoint(s) of evaluation of this end point: When all 20 men have completed the study and have undergone a radical prostatectomy, pathology will be compared to mpMRI and 68Ga-PSMA 11 PET/CT;Secondary end point(s): Furthermore, we want to determine the test-retest variability of the simplified quantitative model for 68Ga-PSMA that follows from part A (Part B). Secondary, we want to assess if 68Ga-PSMA PET/CT is able to localize and identify tumour tissue within the prostate, compared to mpMRI (Part A and B). - Quantify 68Ga-PSMA uptake kinetics in tumour lesions. - Comparison of 68Ga-PSMA PET (study visit) versus mpMRI (standard of care) regarding to tumour localization within the prostate;Timepoint(s) of evaluation of this end point: When all 20 men have completed the study and | — |
Countries
Netherlands
Contacts
Public ContactMarleen Vallinga;Marleen Vallinga;Marleen Vallinga ;;
University Medical Center Groningen;University Medical Center Groningen;University Medical Center Groningen
Outcome results
None listed