Optimisation of [68Ga] PSMA-11 PET/CT Imaging Protocol for localizing primary prostate cancer prior to radical prostatectomy

Phase 3

Completed

Conditions: first diagnosis
Prostate cancer
10038597
10036958

Registration Number: NL-OMON43099

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

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

* 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)

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>This study aims to determine the optimal kinetic model for 68Ga-PSMA uptake<br /><br>and to design a simplified quantitative model for tracer uptake (Part A).To<br /><br>establish the ideal timing of performing the whole body 68Ga-PSMA PET after<br /><br>administration of the radiotracer and to determine the optimal (quantitative)<br /><br>method for measuring 68Ga-PSMA uptake (Part A).<br /><br>To determine whether it is feasible to exactly identify and localize the tumour<br /><br>within the prostate (Part A and B).<br /><br>To study test-retest characteristics of 68Ga PSMA PET (Part B).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Furthermore, we want to determine the test-retest variability of the simplified<br /><br>quantitative model for 68Ga-PSMA that follows from part A (Part B). Secondary,<br /><br>we want to assess if 68Ga-PSMA PET/CT is able to localize and identify tumour<br /><br>tissue within the prostate, compared to mpMRI (Part A and B).<br /><br><br /><br>- Quantify 68Ga-PSMA uptake kinetics in tumour lesions.<br /><br>- Comparison of 68Ga-PSMA PET (study visit) versus mpMRI (standard of care)<br /><br>regarding to tumour localization within the prostate. </p><br>