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The goal of this observational study (multicenter, national registry-based) is to evaluate the performance of 177Lu-ITG-PSMA-1 (177Lu-PSMA-I&T) as therapy in patients with metastatic castration resistent prostate cancer (mCRPC).
The main questions are whether the 177Lu-PSMA-I&T is safe and if it works well to treat patients with progressive mCRPC. The data and information in the study are collected under standard medical therapy and follow-up, so called real-world conditions.
Participants will:
Prospective, multicenter Swiss registry study evaluating the performance of 177Lu-ITG-PSMA-1 (177Lu-PSMA-I&T) as RLT in mCRPC.
Primary endpoint: Safety-
frequency and severity of adverse events (measured according to CTCAE 5.0). Secondary endpoints: Efficacy
biochemical response: best PSA response, PSA50 (>50% decrease from baseline PSA level) and PSA response at 12 weeks
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patient wit progressive mCRPC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radionuclide therapy with 177Lu-PSMA-I&T | Drug | Standard PSMA RLT with 7-8 GBq i.v. infusion of 177Lu-PSMA-I&T performed every 6-8 weeks for 4-6 cycles, or until progression or complete response. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and severity of treatment related adverse event | frequency and severity of treatment related adverse events evaluated on standard blood tests (CBC, liver and kidney function)-, according to CTCAE 5.0 | performed at baseline (before starting the first therapy cycle), during (before each additional therapy cycle) and at 8-14 weeks after completion of all therapy cycles |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy - biochemical response | -measured by changes from baseline PSA (ng/ml), according to the PCWG3 | performed at baseline (before starting the first therapy cycle), during (before each additional therapy cycle) and at 8-14 weeks after completion of all therapy cycles |
| Efficacy - imaging response |
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Inclusion Criteria:
Exclusion Criteria:
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patients with progressive mCRPC who are eligible for PSMA RLT
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| Name | Affiliation | Role |
|---|---|---|
| Alin Chirindel | University Hospital, Basel, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel | Basel | Canton of Basel-City | 4031 | Switzerland | ||
| CHUV |
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objective response rates from, evaluated on morphological imaging according to RECIST criteria and on molecular imaging according to the Consensus statements on PSMA PET/CT response assessment criteria |
| PSMA PET/CT performed at baseline (before starting the first therapy cycle), PSMA SPECT/CT during therapy (24-48 hours after each cycle) and PSMA PET/CT (and/or CT/MRI) at 8-14 weeks after completion of all therapy cycles |
| Quality of life - EORTC PR25 | evaluated with the standardized EORTC PR25 questionnaire | performed at baseline, before each therapy cycle and at 8-14 weeks after completion of all therapy cycles |
| Quality of life - pain | evaluated with the standardized Brief Pain Inventory | performed at baseline, before each therapy cycle and at 8-14 weeks after completion of all therapy cycles |
| Quality of life - Xerostomia | evaluated with the standardized Xerostomia questionnaire | performed at baseline, before each therapy cycle and at 8-14 weeks after completion of all therapy cycles |
| Lausanne |
| Canton of Vaud |
| 1011 |
| Switzerland |
| Kantonspital Aarau | Aarau | 5001 | Switzerland |
| Inselspital | Bern | 3010 | Switzerland |
| Luzerner Kantonsspital | Lucerne | 6000 | Switzerland |
| St. Anna Hirslanden Klinik | Lucerne | 6006 | Switzerland |
| Kantonsspital St. Gallen | Sankt Gallen | 9007 | Switzerland |
| University Hospital Zurich | Zurich | 8091 | Switzerland |