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

University Hospital Basel

Status: Completed

Conditions: mCRPC

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

Study type: Observational

Funder types: Other

Identifiers

NCT06830408

EKNZ 2021-01271

Details and patient eligibility

About

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

Full 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

Enrollment: 250 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

250 participants in 1 patient group

patient wit progressive mCRPC

Treatment:

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