Clinical trial NCT06830408: Performance of 177Lu-PSMA-I&T for RLT in mCRPC - Prospective Multicenter Swiss Registry Study
Official title: Swiss Cancer Registry on Safety and Efficacy of 177Lu-ITG-PSMA-1 Radionuclide Therapy in Prostate Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: mCRPC
Keywords: radioligand therapy
177Lu-PSMA-I&amp;amp;T
registry-study
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2025-02-17
Enrollment: 250
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with progressive mCRPC who are eligible for PSMA RLT

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

Eligibility criteria: 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)

Primary outcomes:
measure: Frequency and severity of treatment related adverse event
timeFrame: 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
Secondary outcomes:
measure: Efficacy - biochemical response
timeFrame: 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: Efficacy - imaging response
timeFrame: 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
measure: Quality of life - EORTC PR25
timeFrame: performed at baseline, before each therapy cycle and at 8-14 weeks after completion of all therapy cycles
measure: Quality of life - pain
timeFrame: performed at baseline, before each therapy cycle and at 8-14 weeks after completion of all therapy cycles
measure: Quality of life - Xerostomia
timeFrame: performed at baseline, before each therapy cycle and at 8-14 weeks after completion of all therapy cycles
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
state: Basel-Stadt
city: Lausanne
country: Switzerland
facility: CHUV
state: VD
city: Aarau
country: Switzerland
facility: Kantonspital Aarau
city: Bern
country: Switzerland
facility: Inselspital
city: Lucerne
country: Switzerland
facility: Luzerner Kantonsspital
city: Lucerne
country: Switzerland
facility: St. Anna Hirslanden Klinik
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Alin Chirindel
role: PRINCIPAL_INVESTIGATOR
References: