Prostate cancer MedDRA version: 20.0 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine & PET
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Histologically verified prostate cancer or clinical suspicion of prostate cancer based on biochemical parameters and/or digital rectal examination - Written and oral consent - Age = 18 years - Planned or ongoing Active Surveillance regimen or planned therapy with curative intent (radical prostatectomy or radiotherapy) 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 32
Exclusion criteria
Exclusion criteria: - Obesity (body weight > 140 kg) - Known allergy towards 68Ga-NOTA-AE105 - Severe claustrophobia - Implanted metal components or devices incompatible with MRI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate 68Ga-NOTA-AE105 PET/MRI in patients with newly diagnosed prostate cancer and the correlation between tracer uptake and Gleason Score;Secondary Objective: To investigate the prognostic value of 68Ga-NOTA-AE105 PET/MRI and the diagnostic accuracy of the method for identifying regional lymph node metastases in patients with newly diagnosed prostate cancer ;Primary end point(s): Correlation between uptake of 68Ga-NOTA-AE105 in primary prostate cancer and Gleason Score evaluated in biopsy material from the tumor;Timepoint(s) of evaluation of this end point: Primary endpoint is evaluated within 3 months from 68Ga-NOTA-AE105 PET/MRI. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Secondary endpoint for patients in active surveillance is progression during the follow-up period (3 years after inclusion). Progression is defined as an increase in risk stratification according to the guidelines of the Danish Urological Cancer Group (DUCG), which is evaluated from PSA level, clinical tumor stage (T stage) and Gleason Score in repeated biopsy. An increase in lymph node stage (N-stage) or detection of distant metastases will also be considered as progression. Time to progression (TTP) is defined as the time from uPAR-PET/MRI to the date where the criteria for progression are met. 2) Secondary endpoint for patients undergoing treatment with curative intent is time to biochemical relapse, defined as an increase in PSA (=0,2 ng/ml) for prostatectomized patients or confirmed PSA increase from nadir + 2 after radiotherapy and endocrine treatment. 3) Secondary end point for all patients is correlation between quantitative MRI parameters (Apparent diffusion coefficient (ADC), Transfer rate constants, choline/citrate ratio, choline+creatinine/citrate ratio) and Gleason Score 4) Secondary endpoint for patients undergoing radical prostatectomy and dissection of pelvic lymph nodes is the diagnostic performance of uPAR-PET/MRI for detection of lymph node metastases;Timepoint(s) of evaluation of this end point: 1) Evaluated 3 years after inclusion 2) Evaluated 3 years after inclusion 3) Evaluated from PET/MRI scan performed within one hour post injection of 68Ga-NOTA-AE105 4) Evaluated within 3 months from PET/MRI | — |
Countries
Denmark
Contacts
Public ContactMarie Øbro Fosbøl
Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine & PET
Outcome results
None listed