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

February 11, 2025 updated by: University Hospital, Basel, Switzerland

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Frequency and severity of treatment related adverse event
Time Frame: 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
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Efficacy - biochemical response
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
performed at baseline, before each therapy cycle and at 8-14 weeks after completion of all therapy cycles
Quality of life - pain
Time Frame: 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
performed at baseline, before each therapy cycle and at 8-14 weeks after completion of all therapy cycles
Quality of life - Xerostomia
Time Frame: performed at baseline, before each therapy cycle and at 8-14 weeks after completion of all therapy cycles
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Basel, Switzerland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alin Chirindel, University Hospital, Basel, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 6, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 12, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 13, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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