Skip to main content
OpenTrials
Completed

NCT Number: NCT06830408

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

MCRPC

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

University Hospital Basel, Basel, Canton of Basel-City, Switzerland

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Feb 17, 2025
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.