prostate cancer prostate carcinoma
Conditions
Interventions
None listed
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - male patients of 18 years and older; - histologically confirmed prostate cancer, no clinical suspicion of metastasis; - patient is scheduled for radical prostatectomy; - capable of cooperating with imaging procedure and follow-up; - World Health Organisation (WHO) performance status 0-2; - signed and dated informed consent.
Exclusion criteria
Exclusion criteria: - current severe and/or uncontrolled and/or unstable other medical disease (e.g. poorly controlled diabetes, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease); - other known malignancies (except local skin cancer); - chemotherapy, radiotherapy, or anti-hormonal therapy prior to study; - 5-alpha-reductase inhibitors prior to study; - significant cardiac arrhythmia current or in patient history; - prior NYHA (New York Heart Association) class III-IV cardiac disease or concurrent congestive heart failure; - prior major thoracic and/or abdominal surgery from which the patient has not yet recovered; - known sensitivity to the study drug or components of the preparation; - other concurrent investigational drugs within the past four weeks; - other condition that, in the opinion of the investigators, would make the patient unsuitable for this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objectives - to assess the safety of 275 MBq [68Ga]Sarabesin 3 (40 µg peptide) in patients with PC; = endpoints: adverse events (AE), with severity grading according to NCI CTCAE version 4.0; the causality of each AE to [68Ga]Sarabesin 3; = outcome measures: blood pressure, heart rate, haemoglobin, leucocytes, thrombocytes, CRP, sodium, potassium, calcium, phosphate, urea, creatinine, total protein, albumin, bilirubin, alkaline phosphatase, ALT, AST, gamma-GT, uric acid, glucose, and gastrin; - to determine the biodistribution of [68Ga]Sarabesin 3 in patients with PC; = endpoint: biodistribution of [68Ga]Sarabesin 3 will be assessed by PET; = outcome measures: qualitative and quantitative data per region of interest per patient within the available time points; | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives - to evaluate the pharmacokinetics of [68Ga]Sarabesin 3 in patients with PC; = endpoint: pharmacokinetic assessment of [68Ga]Sarabesin 3 in blood and if achievable in urine; = outcome measures: determination of degradation products, in plasma 5, 10, 30 and 60 minutes p.i. and urine samples 30 and 60 minutes p.i., time activity curve in blood from 5 min to 180 min p.i.; activity measurement in urine in 4 time frames: 0-30, 30-60, 60-90, 90-180 min p.i.; - to assess the potential of [68Ga]Sarabesin 3 to visualise tumour lesions in patients with biopsy-proven PC that is assumed to be confined to the primary organ; = endpoint: visualisation of primary carcinoma. = outcome measures: imaging judged by two experienced nuclear physicians. - to compare imaging results with receptor expression estimated on tissue samples in vitro; = endpoint: correlation of visibility of prostate cancer lesions by imaging (visual grading and if achievable quantitative) with GRPr density by autoradiography; = outcome measures: in consensus scored scans; SUVmax of tumour lesions; GRPr density in DLU/mm2 on tumour tissue; - to compare histological results with receptor expression estimated on tissue samples in vitro; = endpoint: correlation of results of histological evaluation performed by the pathologist with GRPr density by autoradiography; = outcome measures: Gleason score, size of lesion, GRPr density in DLU/mm2 on tumour tissue. | — |
Countries
Netherlands
Outcome results
None listed