Prostate cancer diagnosis Cancer Malignant neoplasm of prostate
Conditions
Interventions
All participants undergo the same positron emission tomography/computerised tomography (PET/CT) diagnostic test.
Imaging started 1 min after intravenous injection of 925 MBq of 64CuCl2 with acquisit
Sponsors
Magna Graecia University of Catanzaro (Italy)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Age > 18 years 2. High-risk prostate cancer patients defined planned for surgical treatment (radical prostatectomy with lymphadenectomy) 3. Prostate-specific antigen (PSA) > 20 ng/ml 4. Biopsy gleason score 8-10 5. Stage = cT3a 6. Negative bone scintigraphy and magnetic resonance imaging (MRI) of the pelvis negative for metastatic disease
Exclusion criteria
Exclusion criteria: 1. Age < 18 years 2. Evidence of metastatic disease 3. Other tumours diagnosed within the past 5 years, except basal cell or squamous cell skin carcinoma, if properly treated 4. Other medical or psychological diseases that could interfere with the participation in the study and follow-up controls 5. Refusal to participate in the study and anonymous publication of data 6. Participation in other clinical trials, including the follow-up period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the potential value of 64CuCl2 in the preoperative staging of patients with prostate cancer at high risk of extracapsular disease in the form of specificity, sensibility, positive and negative predictive value. Outcome assessment at one month. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Comparative effectiveness with magnetic resonance (MR) for T and N staging 2. Comparative effectiveness with bone scintigraphy for M staging Outcome assessment at one month. | — |
Countries
Italy
Outcome results
None listed