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The Study of 177Lu-TLX591 Plus SOC Versus SOC Alone in Patients With mCRPC (ProstACT Global)

NCT06520345 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 520

Last updated 2026-05-05

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of 177Lu-TLX591 in patients with metastatic castration-resistant prostate cancer who have progressed following treatment with Androgen Receptor Pathway Inhibitor Treatment

Conditions

Interventions

DRUG

177Lu-TLX591

Participants randomized to Group A will receive two 76 mCi (±10%) doses of 177Lu-TLX591 14 days apart

DRUG

Enzalutamide

Enzalutamide (starting dose 160 mg daily)

DRUG

Abiraterone

Abiraterone (starting dose 1,000 mg daily) + prednisone / prednisolone (up to 10 mg per day for the standard formulation)

DRUG

Docetaxel

Docetaxel: Single agent chemotherapy will consist of docetaxel given at a recommended dose of 75mg/m2 IV every 3 weeks given in combination with oral prednisone / prednisolone 5mg twice a day (or equivalent) for up to 10 cycles

Sponsors & Collaborators

  • Telix Pharmaceuticals (Innovations) Pty Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-26
Primary Completion
2027-12-31
Completion
2030-12-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • New Zealand
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT06520345 on ClinicalTrials.gov