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

NCT06830408 | Completed DMC

• 1 other identifier: EKNZ 2021-01271
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 8

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

Conditions

mCRPC

Keywords

radioligand therapy; 177Lu-PSMA-I&T; registry-study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• 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

• Quality of life - EORTC PR25

  performed at baseline, before each therapy cycle and at 8-14 weeks after completion of all therapy cycles

• Quality of life - pain

  performed at baseline, before each therapy cycle and at 8-14 weeks after completion of all therapy cycles

• Quality of life - Xerostomia

  performed at baseline, before each therapy cycle and at 8-14 weeks after completion of all therapy cycles

Study Arms (1)

patient wit progressive mCRPC

Drug: radionuclide therapy with 177Lu-PSMA-I&T

Interventions

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.

patient wit progressive mCRPC

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with progressive mCRPC who are eligible for PSMA RLT

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (8)

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Kantonspital Aarau

Aarau, 5001, Switzerland

Location

Inselspital

Bern, 3010, Switzerland

Location

Luzerner Kantonsspital

Lucerne, 6000, Switzerland

Location

St. Anna Hirslanden Klinik

Lucerne, 6006, Switzerland

Location

Kantonsspital St. Gallen

Sankt Gallen, 9007, Switzerland

Location

University Hospital Zurich

Zurich, 8091, Switzerland

Location

Study Officials

• Alin Chirindel

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2025
• First Posted: February 17, 2025
• Study Start: July 6, 2020
• Primary Completion: November 12, 2024
• Study Completion: January 13, 2025
• Last Updated: February 17, 2025

Record last verified: 2025-02

Locations

CH (8)