Prostate neoplasia with local or metastatic recurrence
Conditions
Interventions
Estimated number of patients: 200 patients from multiple centers in Brazil. Procedure and administration mode: oncologists and / or urologists will be contacted to offer participation in the clinical
Drug
Radiation
Other
E01.370.350.350.800.700
D01.496.360.400
Sponsors
MJM Produtos Farmaceuticos e de Radioprotecao Ltda
Real e Benemerita Associação Portuguesa
Eligibility
Sex/Gender
Male
Age
18 Years to 125 Years
Inclusion criteria
Inclusion criteria: Volunteer 18 years of age or older submitted to curative treatment of prostate cancer. Prostatectomy and presenting biochemical prostate cancer recurrence. Indicating PSA> 0.2 ng/ml level. Curative radiochemical therapy and presenting biochemical prostate recurrence. Indicating PSA> 2.0 ng/ml. Result of at least one of the following exams. MDP-Tc-99m bone scintigraphy. Nuclear Magnetic Resonance. Computed Tomography, or Positron Emission Tomography with Fluordeoxiglucose-F-18. Being capable of understand and sign the informed consent.
Exclusion criteria
Exclusion criteria: Radiopharmaceutical therapy administered within four weeks or in a smaller time interval than five half-lives of the used agent. Active infection or fever not explained> 38.5 ° C during screening visits or on the day of the examination. Known hypersensitivity to any of the components Ga-68. HBED-CC. PSMA or excipient of PSMAHBED DC-kit. Any other medical or social condition considered by the investigator prone to interfere with the patient's ability to sign the consent cooperate and participate in the study or interfere with the interpretation of the results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The detection rate and sensitivity are the primary outcomes of this study. The detection rate is defined as the number of patients where there are findings in PET / CT-PSMA HBED-Ga68. Sensitivity is defined as the ratio of true positive individuals among patients (men with prostatectomy - PSA> 0.2 ng / ml and men with radiotherapy - PSA> 2.0 ng / ml); that is; positive for standard imaging (scintigraphy, MRI, CT PET with FDG-F-18) and the PET / CT with HBED-PSMA-Ga68. A total of 200 men will be included in the study. For this number of participants, it was considered margin of error estimates for proportion (p) = 0.50 (the maximum error) and p = 0.80 in the correlation measures and accuracy in different scenarios. To measure the correlation between methods beyond the nominal proportion of correct answers we will use the weighted Kappa statistic and its respective 95% confidence interval. For the sensitivity and detection rate will use the binomial distribution and their 95% confidence intervals. Categorical variables are summarized by frequency distributions (number and percentage of patients). Continuous variables are summarized as average and standard deviation. The above analyzes are also carried out stratified according to clinical groups defined by PSA levels, Gleason score, performing prostatectomy and performing curative radiotherapy. All analyzes will be performed using SPSS version 22.0 (SPSS Inc, Chicago, IL). A 95% confidence interval will be calculated using Fisher's exact method of intervals. All analyzes will be performed using SPSS version 22.0 (SPSS Inc, Chicago, IL). | — |
Secondary
| Measure | Time frame |
|---|---|
| No secundary outcome is expected. | — |
Countries
Brazil
Contacts
Public ContactRafael Madke
MJM Produtos Farmaceuticos e de Radioprotecao Ltda
Outcome results
None listed