Prostate Cancer MedDRA version: 20.0 Level: PT Classification code 10036911 Term: Prostate cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10066489 Term: Progression of prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10076506 Term: Castration-resistant prost
Conditions
Interventions
Product Name: 68Ga-PSMA-11 prepared using PSMA-11 sterile cold kit
Pharmaceutical Form: Solution for injection
INN or Proposed INN: PSMA-11 (68Ga)
Other descriptive name: 68GA-PSMA HBED-CC
Concentrati
Sponsors
ICNAS Produção Lda.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Patients that gave free written consent to participate in the study trough the Inform Consent Form; ¿ Patients willing to comply with all study procedures and show availability for the duration of the study; ¿ Men with age between 18 and 80 years old at time of enrolment; ¿ Patients diagnosed with prostate cancer that have followed a radical treatment by prostatectomy or radiotherapy; o Biochemical relapse: After surgery: the last two PSA measurements had values >0.2ng/ml. After radiotherapy: PSA increase of 2.0ng/ml above the nadir. o Residual disease: After surgery: positive PSA level after surgery After radiotherapy: two consecutive PSA measurements PSA>0.2 ng/ml (attention to false positives). ¿ Patients that have a prescription to perform a 18F-Fluorocholine PET/CT scan; ¿ Patients with PSA level =65 years) yes F.1.3.1 Number of subjects for this age range 16
Exclusion criteria
Exclusion criteria: Patients presenting a known hypersensitivity to the active substance or any excipient of the investigational drug; ¿ Patients with known malignant disease, irrespectively of how long it has been diagnosed (with the exception of basal-cell carcinomas); ¿ Patients with alcohol or drug addiction, who have a serious illness, mental disorder or any other cause that could affect their participation in the study; ¿ Patients exposed to any investigational drug or device in the six months prior to the date of enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the diagnostic superiority of 68Ga-PSMA-11 PET/CT imaging (68Ga-PSMA-11 labelled using PSMA-11 Sterile Cold Kit, ANMI, and gallium-68 obtained by generator or other gallium-68 source, cyclotron) over 18F-Fluorocholine PET/CT imaging in the detection of recurrence sites of prostate cancer after radical treatment.;Secondary Objective: To compare the diagnostic impact of 68Ga-PSMA-11 PET/CT imaging over 18F-Fluorocholine PET/CT imaging; ¿ To compare the impact of 68Ga-PSMA-11 PET/CT imaging over 18F-Fluorocholine PET/CT imaging on the therapeutic decision (minor and/or major therapeutic changes with regards to the number and/or lesion(s) location(s)); ¿ To compare the sensibility, specificity and predictive values of 68Ga-PSMA-11 PET/CT and 18F-Fluorocholine PET/CT imaging. ¿ Safety evaluation.;Primary end point(s): Comparison of the number of prostate cancer lesions detected using 68Ga-PSMA-11 PET/CT and 18F-Fluorocholine PET/CT imaging.;Timepoint(s) of evaluation of this end point: An independent expert committee will meet after all patients are out of the study to confirm the detected lesions (3 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Sensibility, specificity and positive and negative predictive values for presence of distant disease, for each PET imaging tracer (+CI 95%); ¿ Determination of the number of lesions detected using 68Ga-PSMA-11 PET/CT and 18F-Fluorocholine PET/CT imaging and evaluation of the detection rate, SUVmax and TBR of the lesions per organ; ¿ Determination of the number of patients with changes in the diagnosis and/or treatment following the results of the different PET/CT imaging scans assessment; ¿ Sensibility, specificity and positive and negative predictive values for each PET/CT imaging tracer (+CI 95%); ¿ Number of adverse events or serious adverse events in relation with the study drug (description of the adverse events, incidence, severity and causality).;Timepoint(s) of evaluation of this end point: An independent expert committee will meet after all patients are out of the study to confirm the detected lesions (3 months) The main objective of this trial is to assess the superiority of diagnosis using68Ga-PSMA-11 PET/CT in comparison with 18F-Fluorocholine PET/CT, therefore it is important to evaluate not only the number of lesions detected but also the diagnostic aquitity, clinical significance and quantity parameters like SUVmax and TBR. | — |
Countries
Portugal
Contacts
Public ContactAntero Abrunhosa
ICNAS Produção Lda.
Outcome results
None listed