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

NCT ID: NCT06830408

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-06
• Study Completion Date: 2025-01-13

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

Conditions

mCRPC

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

patient wit progressive mCRPC

radionuclide therapy with 177Lu-PSMA-I&T

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alin Chirindel

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

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

Countries

Switzerland

Other Identifiers

EKNZ 2021-01271

Identifier Type: -

Identifier Source: org_study_id