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Study of [177Lu]Lu-PSMA-137 In Metastatic Castrate Resistant Prostate Cancer（mCRPC）

NCT06546527 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-08-09

No results posted yet for this study

Summary

This study is a prospective, single-center, single-arm clinical trial consisting of two parts. In Part A, 3 participants were enrolled to receive sequential administrations of low doses of \[177Lu\]Lu-PSMA-137 and \[177Lu\]Lu-PSMA-617. Pharmacokinetics（PK） sampling and single-photon emission computed tomography/computed tomography (SPECT/CT) scans were performed at scheduled time according to the protocol. Based on quantitative pharmacological results, the optimal dosing regimen for \[177Lu\]Lu-PSMA-137 was derived. In Part B, 3 participants were enrolled to receive treatments with 50% and 100% of the optimal dose of \[177Lu\]Lu-PSMA-137, to preliminarily evaluate the safety, tolerability, radiation dosimetry, and efficacy of \[177Lu\]Lu-PSMA-137 in participants with metastatic castration resistant prostate cancer (mCRPC).

Conditions

Interventions

DRUG

[177Lu]Lu-PSMA-137

\[177Lu\]Lu-PSMA-137 500 MBq;50% optimal dosing;100% optimal dosing

Sponsors & Collaborators

  • Peking University First Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2025-03-01
Completion
2026-12-01

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06546527 on ClinicalTrials.gov