mCRPC
Conditions
Keywords
radioligand therapy, 177Lu-PSMA-I&T, registry-study
Brief summary
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
Detailed description
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
Interventions
DRUGradionuclide therapy with 177Lu-PSMA-I&T
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.
Sponsors
University Hospital, Basel, Switzerland
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* hormone-refractory and PSMA PET/CT-positive prostate tumors * progressed after or are ineligible for chemotherapy, next-generation antihormonal therapy or bone-directed radiation therapy -- male patients with an age above 18 years
Exclusion criteria
* patients who are not eligible for PSMA RLT, according to current, standard medical indications and guidelines * patients who for medical or non-medical reasons are unable to give their consent * patients withdrawing their consent for participation (NB: the already collected data in such cases will be anonymized and further used for applicable analyses)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency and severity of treatment related adverse event | 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 | frequency and severity of treatment related adverse events evaluated on standard blood tests (CBC, liver and kidney function)-, according to CTCAE 5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy - biochemical response | 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 | -measured by changes from baseline PSA (ng/ml), according to the PCWG3 |
| Efficacy - imaging response | 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 | 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 |
| Quality of life - EORTC PR25 | performed at baseline, before each therapy cycle and at 8-14 weeks after completion of all therapy cycles | evaluated with the standardized EORTC PR25 questionnaire |
| Quality of life - pain | performed at baseline, before each therapy cycle and at 8-14 weeks after completion of all therapy cycles | evaluated with the standardized Brief Pain Inventory |
| Quality of life - Xerostomia | performed at baseline, before each therapy cycle and at 8-14 weeks after completion of all therapy cycles | evaluated with the standardized Xerostomia questionnaire |
Countries
Switzerland
Outcome results
None listed