prostate cancer
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Histologically proven prostate cancer - Patients selected for a radical prostatectomy (part of normal treatment) - Willingness to cooperate in the study; written informed consent given - >60 years of age
Exclusion criteria
Exclusion criteria: - Any signs of neurological or psychiatric disorders that will preclude the patient from expressing its own free will - Any signs of disease that will prevent the patient from lying in the same position for an hour. - Other medical research in which patients have been submitted to radiation during the last year - serum kreatinine >110 umol/l - Any signs or prior history of other malignancy in pelvis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - An interim analysis of the first 5 scans will be made to determine the optimal scanning procedure (see study procedure paragraph 3 of this chapter). After this interim analysis, all scans will be performed in the same way for the remaining patients. In the first 5 patients also the pharmacokinetic properties of the tumour in the first 20 minutes will be determined. The interim analysis will also show if the CT is able to correctly discriminate between prostatic uptake and excretion of activity via the bladder. Prior studies with SPECT/CT have shown that bladder drainage is not necessary. But, if needed we will apply continues bladder drainage via an urinary catheter that is inserted prior to the scan. - Pharmacokinetics of the radiopharmaceutical will be determined in serum that is obtained via an arterial canula at several intervals (canula placed prior to tracer injection). - Detection of prostate cancer, number, position, size and intensity of hotspots (tumour-to-background ratio, subjective scoring by 2 nuclear physicians) with the use of 99MTc-HABN SPECT/CT, comparison with clinical parameters (clinical tumour stage, overall Gleason score, serum PSA) and comparison to histologic results of the prostate specimen after radical prostatectomy (number, position, size, Gleason score of prostate cancer lesions, proliferation score of each lesion (Ki-67 staining), staining for GRPR of each lesion). | — |
Secondary
| Measure | Time frame |
|---|---|
| - As this is a *first in men* study, the heart-rate and blood-pressure of all patients will be monitored during the first hour after injection with pulsoxymeter and blood pressure-monitor. - Significant changes (>15% change in heart-rate, >15 mmHg change in systolic and/or diastolic blood pressure) and other reported side-effects will be documented for all patients. | — |
Countries
Netherlands
Outcome results
None listed