metastatic prostate cancer MedDRA version: 12.1 Level: LLT Classification code 10036909 Term: Prostate cancer metastatic
Conditions
Interventions
Product Name: [11C]Choline
Product Code: [11C]Choline
Pharmaceutical Form: Solution for injection
INN or Proposed INN: CHOLINE CHLORIDE
CAS Number: 67481
Concentration unit: MBq/ml megabecquerel(s)/mi
Sponsors
Cancer Research UK
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Histologically proven prostate cancer 2. At least 4 new metastatic bone lesions, as identified by conventional imaging with bone scintigraphy 3. Either: a) Treatment naive for prostate cancer OR b) Castration refractory prostate cancer [castrate will be defined as a testosterone level of =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. For treatment naive patients any prior radiotherapy, hormone therapy, chemotherapy, endocrine therapy, or immunotherapy, for treatment of prostate cancer For castration refractory patients any prior radiotherapy, chemotherapy, or immunotherapy for treatment of prostate cancer 2. Patients with partners of child-bearing potential (unless they agree to take measures not to father children by using two forms of medically approved contraception during the trial) 3. Patients with the following conditions which would prevent compliance with the scanning protocol: - Diabetes - High levels of pain / discomfort - Urinary incontinence 4. Major thoracic and/or abdominal surgery from which the patient has not yet recovered. 5. History of recent significant cardiac arrhythmia 6. Concurrent congestive heart failure or prior history of class III/IV cardiac disease (NYHA) 7. Any other condition which in the Investigator’s opinion would not make the patient a good candidate for the clinical trial 8. Participation or planned participation in any other interventional clinical trial, whilst taking part in this trial. Participation in an observational trial would be acceptable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare [18F]choline to [11C]choline in their ability to detect metastatic prostate cancer.;Secondary Objective: 1. To compare the best early phase (immediate) scanning of the two agents against the late phase (one hour delayed) [18F]choline scanning in their ability to detect metastatic prostate cancer. 2. To assess the safety of [11C]choline and [18F]choline in patients with prostate cancer.;Primary end point(s): Identification of a true 5% difference in lesion detection using the [18F]choline to [11C]choline | — |
Countries
United Kingdom
Outcome results
None listed