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: * undergo regular radioligand therapy (RLT) with 177Lu-PSMA-I\&T * have clinical, laboratory and imaging follow-up according to the currently available recommendation for PSMA-RLT an in line with their medical needs. * answer study related set of questionnaires
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 * imaging response: Objective response rate evaluated on follow-up morphological imaging CT/MRI and/or on molecular imaging PSMA PET/CT * quality of life: evaluated with standardized questionnaires
Study Type
OBSERVATIONAL
Enrollment
250
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.
University Hospital Basel
Basel, Canton of Basel-City, Switzerland
CHUV
Lausanne, Canton of Vaud, Switzerland
Kantonspital Aarau
Aarau, Switzerland
Inselspital
Bern, Switzerland
Luzerner Kantonsspital
Lucerne, Switzerland
St. Anna Hirslanden Klinik
Lucerne, Switzerland
Kantonsspital St. Gallen
Sankt Gallen, Switzerland
University Hospital Zurich
Zurich, Switzerland
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
Time frame: 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 - biochemical response
-measured by changes from baseline PSA (ng/ml), according to the PCWG3
Time frame: 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
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: performed at baseline, before each therapy cycle and at 8-14 weeks after completion of all therapy cycles
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