prostate cancer, prostaatkanker
Conditions
Interventions
Not applicable, the study design is: A monocenter, prospective observational study in 20 patients with primary prostate cancer. The study consists of two parts: part A, to determine the tracer kinetic
Sponsors
Universiy Medical center Groningen (UMCG)
Eligibility
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).
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To establish the ideal timing of performing the WB 68Ga-PSMA PET after administration of the radiotracer and to determine the optimal (quantitative) pharmacokinetic model for describing 68Ga-PSMA uptake (Part A). To study test-retest characteristics of 68Ga PSMA PET (Part B). | — |
Secondary
| Measure | Time frame |
|---|---|
| - To determine whether it is feasible to exactly identify and localize the tumour within the prostate with PSMA PET/CT(Part A and B). - Comparison of 68Ga-PSMA PET (study visit) versus mpMRI (standard of care) regarding to tumour localization within the prostate. | — |
Contacts
Public ContactA.H. Brouwers
Postbus 30001
Outcome results
None listed