Prostate Cancer
Conditions
Brief summary
Prospective study to evaluate the value of uPAR-targeted PET/MR scan using the tracer 68Ga-NOTA-AE105 in patients with newly diagnosed prostate cancer
Detailed description
Prostate cancer is one of the most frequent types of cancer in men. The characteristics of the disease varies significantly among patients where some have an indolent type of cancer, from which they will never experience symptoms while others have highly aggressive malignant disease that requires prompt therapeutic action. Treatment of localized prostate cancer is based on a risk stratification, where patients are either offered therapy with curative intent - surgery or radiotherapy - or in case of low-risk disease an active surveillance strategy can be advised. In active surveillance the disease is monitored by PSA measurement, repeated biopsies and digital rectal examination. Some patients progress during active surveillance to a higher risk classification, which may lead to selection of active therapy. The aim of this study is to investigate positron emission tomography (PET) with the radiolabelled tracer 68Ga-NOTA-AE105, combined with magnetic resonance imaging (MRI) in patients with newly diagnosed prostate cancer. 68Ga-NOTA-AE105 targets the receptor urokinase-type plasminogen activator receptor (uPAR), which is a known marker for aggressive disease in prostate cancer.
Interventions
DRUG68Ga-NOTA-AE105
PET/MRI scan
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically verified prostate cancer * Capable of understanding written information and giving informed consent * Planned to enter active surveillance strategy or undergo therapy with curative intent (surgery or radiotherapy)
Exclusion criteria
* Obesity (Body weight over 140 kg) * Known allergy to 68-Ga-NOTA-AE105 * Metallic components in the body that contradicts MRI scan * Severe claustrophobia making the person unable to complete an MRI scan
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation with Gleason Score | 3 months after PET/MRI | Correlate the uptake of 68Ga-NOTA-AE105 with Gleason Score obtained from biopsy material. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prognostic value | 3 years from PET/MRI | Evaluate the prognostic value of uPAR PET/MRI in patients with prostate cancer either undergoing therapy with curative intent or active surveillance. |
| Diagnostic accuracy in staging lymph nodes | 3 months from PET/MRI | Evaluate the diagnostic accuracy of uPAR PET/MRI in identifying regional lymph node metastases in patients with newly diagnosed prostate cancer |
Countries
Denmark
Outcome results
None listed