Performance of 177Lu-PSMA-I&T for RLT in mCRPC - Prospective Multicenter Swiss Registry Study

Swiss Cancer Registry on Safety and Efficacy of 177Lu-ITG-PSMA-1 Radionuclide Therapy in Prostate Cancer Patients

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

Study Overview

• Status: Completed
• Conditions: mCRPC
• Intervention / Treatment: Drug: radionuclide therapy with 177Lu-PSMA-I&T

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

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• Switzerland
  • Aarau, Switzerland, 5001
    • Kantonspital Aarau
  • Bern, Switzerland, 3010
    • Inselspital
  • Lucerne, Switzerland, 6000
    • Luzerner Kantonsspital
  • Lucerne, Switzerland, 6006
    • St. Anna Hirslanden Klinik
  • St. Gallen, Switzerland, 9007
    • Kantonsspital St. Gallen
  • Zurich, Switzerland, 8091
    • University Hospital Zurich
  • Basel-Stadt
    • Basel, Basel-Stadt, Switzerland, 4031
      • University Hospital Basel
  • VD
    • Lausanne, VD, Switzerland, 1011
      • CHUV

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

patients with progressive mCRPC who are eligible for PSMA RLT

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patient wit progressive mCRPC	Drug: radionuclide 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Alin Chirindel, University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2020
• Primary Completion (Actual): November 12, 2024
• Study Completion (Actual): January 13, 2025

Study Registration Dates

• First Submitted: January 30, 2025
• First Submitted That Met QC Criteria: February 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: radioligand therapy; 177Lu-PSMA-I&T; registry-study
• Other Study ID Numbers: EKNZ 2021-01271

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No