E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prostate Cancer |
Cancro da Próstata |
|
E.1.1.1 | Medical condition in easily understood language |
Prostate Cancer |
Cancro da Próstata |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10036911 |
E.1.2 | Term | Prostate cancer recurrent |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066489 |
E.1.2 | Term | Progression of prostate cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10076506 |
E.1.2 | Term | Castration-resistant prostate cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10036909 |
E.1.2 | Term | Prostate cancer metastatic |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10060862 |
E.1.2 | Term | Prostate cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10036917 |
E.1.2 | Term | Prostate cancer stage I |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10036918 |
E.1.2 | Term | Prostate cancer stage II |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10036919 |
E.1.2 | Term | Prostate cancer stage III |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10036920 |
E.1.2 | Term | Prostate cancer stage IV |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036910 |
E.1.2 | Term | Prostate cancer NOS |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10062904 |
E.1.2 | Term | Hormone-refractory prostate cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10071119 |
E.1.2 | Term | Hormone-dependent prostate cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
Avaliar a superioridade de diagnóstico imagiologico por PET/CT com 68Ga-PSMA-11 (68Ga-PSMA-11 marcado com um kit frio de PSMA-11 da ANMI e com gálio-68 obtido por gerador ou ciclotrão)em relação ao diagnóstico imagiologico por PET/CT com 18F-Fluorocolina na detecção de recidivas de cancro da próstata após tratamento radical. |
|
E.2.2 | Secondary objectives of the trial |
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. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 <10 ng/ml at study inclusion; ¿ Patients with a life expectancy superior to 12 months; ¿ Patients considered for local salvage treatment ¿ Patients with an ECOG performance status ¿ 2; ¿ Patient under the National Healthcare System; ¿ Patients physically and psychologically able to participate in the study. |
|
E.4 | Principal 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.
|
|
E.5 End points |
E.5.1 | 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. |
|
E.5.1.1 | 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) |
|
E.5.2 | 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). |
|
E.5.2.1 | 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. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
18F-Fluorocolina |
18F-Fluorocholine |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
A participant is considered to have completed the study when he has completed all the study visits including the last scheduled procedure shown in the Schedule of Activities (final expert meeting after the last patient finish SoA). After the end of the study all patients will continue to follow the normal routine in Urology and Renal Transplantation Service at the Hospital and University Centre of Coimbra with the standard procedures from the National Healthcare System.
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 20 |
E.8.9.1 | In the Member State concerned days | 0 |