Prostate Carcinoma in patients with biochemical relapse.
Conditions
Interventions
Product Name: (18F) Fluorometilcolina
Product Code: 18f-FCH
Pharmaceutical Form: Solution for injection
INN or Proposed INN: 18F-FCH
Current Sponsor code: 18F-FCH
Other descriptive name: 18F-FLUOROMET
Sponsors
Instituto Tecnológico PET, S.A.U. (ITP)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.Male.2.Age=18 years.3. Patients with biochemical relapse of Prostate Carcinoma who have reached any of the following serum PSA levels after a previous primary radical treatment: In patient treated with radical prostatectomy must have passed at least 3 months from the urgery and PSA value will be: (a) higher than 1.0 ng / mL or (b) higher than 0.4 ng / mL in cases of doubling time of less than 6 months. In the patients treated with external radiotherapy or brachytherapy, PSA elevation will be: (c) higher than 2 ng / mL over the nadir. 4. That he has been made an image test (CT with contrast (intravenous and oral), MRI and / or bone scan) up to a maximum of 15 days before the PET-TC with 18F-FCH, or it is scheduled to perform this test in a maximum of 15 days after the PET-TC with 18F-FCH. Contrast CT (intravenous and oral) data are also valid if they are performed with the PET scan with 18F-FCH. 5. Capability to undergo to the explorations. 6. With the signed and dated Informed consent, accepting the participation in the study. 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 53 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 54
Exclusion criteria
Exclusion criteria: 1.- Surgery performed on the month previous to the PET-CT with 18F-FCH performance. 2. - Prostate biopsy performed on the month before the PET-CT with 18F-FCH test. 3. - Diagnosis of a second primary neoplasia. 4.- Concomitant medication, nutritional supplements or dietetic products containing choline. 5.- Previous known allergic reaction to any of the formulation components of the 18F-FCH or to the contrasts (intravenous or oral) used for the CT. 6.- Life expectancy of less than 6 months. 7.- Lack of cooperation of the patient to participate (following the investigator criteria). 8.- Participation in other clinical trial during the month previous to the inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the diagnostic efficiency in terms of the classification probabilities (sensitivity and specificity) of the PET CT with 18F-FCH in demonstrating the recurrence of prostate cancer in patients with biochemical relapse who have undergone radical primary treatment, using as reference standard the histology of the lesions (in some cases the confirmation of the diagnosis can be made with clinical follow-up);Secondary Objective: 1-Diagnostic efficiency of the PET CT with 18F-FCH. In a complementary manner, the Diagnostic efficiency using each lesion as analysis unit.2- To evaluate the impact on the diagnostic process of prostate cancer recurrence 3- To evaluate the diagnostic efficiency of the TC with contrast- (intravenous and oral) as an isolated test 4- To evaluate the diagnostic efficiency of the MR as an isolated test 5- To evaluate the diagnostic efficiency of the bone scan (OG)as an isolated test 6- To evaluate the diagnostic efficiency of the PET in the utility of the test terms 7- Evaluation of the influence of the diagnostic performance of PET-TC with 18F-FCH of the serum PSA parameters, doubling time, PSA velocity, radical primary treatment, reference standard and clinical situation. To evaluate the detection threshold of PET-CT with 18F-FCH. 8- To calculate the correlation values. To evaluate the SUVmax positivity threshold.9- Safety Evaluation of PET-TC with 18F-FCH;Primary end point(s): To evaluate the diagnostic efficiency of the PET-CT on an individual level;Timepoint(s) of evaluation of this end point: The corresponding specialist will consider the test positive if there is evidence of abnormal catchment in any location under evaluation. Likewise, the reference compare will be positive if there is evidence of a clinical relapse in any location. All imaging tests evaluated in the study objectives will be performed within the period of 15 days before or after the PET-TC with 18f-FCH has been performed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.-Demonstration, in separate, of the clinical relapses, local-regional and at distance. 2. - Evaluate the impact of the PET-CT over the reasonable diagnostic. 3. - Evaluate the secondary objectives related to the accuracy of the diagnostic with other imaging technics (CT with contrast, MRI and bone gamagraphy). 4. - Evaluate the influence of several factors over the efficiency of the diagnostic with PET-CT. 5.- Complete empiric estimations for the ROC curve. 6.- Analyze the safety of the radio tracer.;Timepoint(s) of evaluation of this end point: During the performance of the imaging test. During the following 24 hours to the performance of the image test. During each patient's participation in the study (except those occurring in the course of the image test or within the following 24 hours) | — |
Countries
Spain
Contacts
Public ContactEmilio Viñas Navarro
Instituto Tecnológico PET, S.A.U. (ITP)
Outcome results
None listed