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| Name | Class |
|---|---|
| Medical Research Agency, Poland | OTHER_GOV |
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The aim of multicentre phase 3 trial is evidence diagnostic value of 68Ga-PSMA-11 (in PET / CT and PET / MR techniques) in patients with high-risk and intermediate prostate cancer before radical treatment and in diagnosed patients biochemical recurrence after radical treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1- patient of middle and high risk of prostate cancer | Active Comparator | Patients with diagnosis or high probability of prostate cancer medium and high risk according to ISUP for which implementation is planned radical treatment [i.e. PSA≥10 ng / ml or GS ≥ 7 (ISUP ≥2) or ≥cT2b]. |
|
| Group 2- patient after radical treatment, at relapse biochemical | Active Comparator | Prostate cancer patients after radical treatment, with recurrence biochemical tests according to the criteria of the European Society of Urology (EAU, European Association of Urology) [at least double measurement PSA ≥0.2 ng / ml not earlier than 6-13 weeks after radical prostatectomy or PSA≥0.1 with PSAdt (PSA doubling time) <3 months or increase in PSA after radical radiotherapy> 2 ng / ml above PSAnadir - the lowest PSA value found after the test treatment] for whom further treatment is planned and the test result imaging / molecular imaging may alter the therapeutic decision |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiopharmaceutical 68Ga-PSMA-11 PET/CT | Radiation | The radiopharmaceutical will be administered intravenously in doses with an activity of 1.8-2.2 MBq / kg b.w. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensivity of the radiopharmaceutical 68Ga-PSMA-11 compared to PET/MR and PET/CT | Validation of the diagnostic value of 68Ga-PSMA-11 (in PET / CT and PET / MR techniques) in the assessment stage of prostate cancer and precise assessment of the location of neoplastic changes. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Establishing a therapeutic path depending on the PET/MR and PET/CT | Percentage of patients with 68Ga-PSMA-11 PET / CT and 68Ga-PSMA-11 PET / MR will lead to a change in the therapeutic path | 24 months |
| Detection of the site of recurrence |
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Inclusion Criteria:
Group 1. Patients with diagnosis or high probability of medium and high prostate cancer according International Society of Urological Pathology (ISUP) risk for whom radical treatment is planned
Group 2. Patients with RGK after radical treatment, with biochemical recurrence according to EAU criteria, who are scheduled for further treatment and the result of the imaging / molecular examination may affect change of therapeutic decision:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ewa Sierko, Professor | Contact | 85 664 67 83 | ewa.sierko@iq.pl | |
| Clinical Research Support Center Medical University of Bialystok | Contact | 85 686 53 86 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Białystok Oncology Center Maria Skłodowska-Curie | Recruiting | Bialystok | 15-027 | Poland |
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Comparison of the frequency of detecting the site of recurrence after examination with standard methods, 68Ga-PSMA-11 PET / CT and 68Ga-PSMA-11 PET / MR (only for the second group)
| 24 months |
| Determination of PSA concentration | Determination of the PSA concentration at which the 68Ga-PSMA-11 PET / MR test enables detection of local or regional recurrence (only for the second group) | 24 months |
| Number of participants with adverse events related to 68Ga-PSMA-11 | Serious adverse events are not expected. The radiotracer 68Ga-PSMA-11 is dose by the intravenous route in trace amounts and does not affect the patient's well-being. The use of 68Ga-PSMA-11 is contraindicated in kidney failure and allergies to the ingredients of the preparation (all patients will have their serum creatinine measured before the test). | 24 months |
| Absorbed radiation dose | Assessment and comparison of the absorbed radiation dose during the 68Ga-PSMA-11 PET / CT examination and 68Ga-PSMA-11 PET / MR | 24 months |
| Evaluation of pharmacoeconomic data | Comparison of the costs of the procedures planned for performance after the first visit, and those that were actually made after conducting the assessed tests | 24 months |
| University Clinical Hospital in Białystok | Recruiting | Bialystok | 15-276 | Poland |
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| Independent Public Health Care Center of the Ministry of Internal Affairs and Administration in Białystok | Not yet recruiting | Bialystok | 15-471 | Poland |
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| Laboratory of Molecular Imaging and Technology Development | Recruiting | Bialystok | 15-540 | Poland |
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| Oncology Center named after prof. F. Łukaszczyk in Bydgoszcz | Recruiting | Bydgoszcz | 85-796 | Poland |
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| Provincial Multidisciplinary Center of Oncology and Traumatology named after M. Copernicus University in Łódź | Not yet recruiting | Lodz | 93-513 | Poland |
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| Center of Oncology of the Lublin Region St. Jana z Dukli | Recruiting | Lublin | 20-090 | Poland |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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