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multi-centre, prospective, diagnostic trial to evaluate the Prostate-Specific Membrane Antigen (PSMA-antigen) over-expression in metastatic castration resistant prostate cancer (mCRPC) and in advanced/metastatic solid tumors patients.
Multi-centre, prospective, diagnostic trial to evaluate the Prostate-Specific Membrane Antigen (PSMA-antigen) over-expression in metastatic castration resistant prostate cancer (mCRPC) and in advanced/metastatic solid tumors patients.
The primary objective of this study is to evaluate the detection rate of PSMA PET/CT, defined as the ratio of PSMA-positive patients and the total number of cancer patients with known advanced/metastatic disease that performed a PSMA PET/CT as part of the present study. A positive patient is defined as a patient with at least one PSMA-positive lesion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 68Ga-PSMA | Experimental | 68Ga-PSMA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-PSMA | Drug | 68Ga-PSMA will be injected intravenously via an indwelling catheter in an antecubital vein; (68Ga-PSMA activity: min 100 MBq - max 200 MBq, weighted activity: 2.0 MBq/Kg). |
| Measure | Description | Time Frame |
|---|---|---|
| detection rate of 68Ga-PSMA PET/CT | the proportion of 68Ga-PSMA- positive patients and the total number of recruited patients in two groups population's (metastatic castration-resistance prostate cancer and various origin solid tumors). | up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety is defined as the number and percentage of treated patients undergoing grade 1 to 4 adverse events according to CTCAE version 4.03 | Safety is defined as the number and percentage of treated patients undergoing grade 1 to 4 adverse events according to CTCAE version 4.03 | up to 36 months |
| Lesion detection rate stratified per tumor histotypes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paola Caroli, MD | IRST IRCCS | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) | Meldola | FC | 47014 | Italy |
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| ID | Term |
|---|---|
| C000718244 | gallium 68 PSMA-11 |
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Proportion of positive patients on total number who underwent 68Ga-PSMA PET/CT stratified for tumor histotypes; |
| up to 36 months |
| Lesion detection rate stratified for different lesion sites | Proportion of positive patients on total number who underwent 68Ga-PSMA PET/CT stratified for different lesion sites; | up to 36 months |
| Changes in 68Ga-PSMA uptake in patients with other solid tumors who receive anti-angiogenetic therapies according to objective clinical response; | Changes in 68Ga-PSMA uptake in patients and correlation with clinical response to 177Lu-PSMA therapy for prostate cancer, or other angiogenic therapy. | up to 36 months |