MedTrace Logo

In Men With Metastatic Prostate Cancer, What is the Safety and Benefit of Lutetium-177 PSMA Radionuclide Treatment in Addition to Chemotherapy

NCT04343885 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2025-07-11

No results posted yet for this study

Summary

This phase 2 randomised clinical trial will compare the effectiveness of Lu-PSMA therapy followed by docetaxel chemotherapy versus docetaxel chemotherapy on its own in patients with newly-diagnosed high-volume metastatic hormone-naive prostate cancer (mHNPC).

Conditions

  • Metastatic Hormone Naive Prostate Cancer

Interventions

DRUG

177Lu-PSMA-617

Patients will be given 7.5GBq of 177Lu-PSMA every 6 weeks for 2 cycles.

DRUG

Docetaxel

Docetaxel 75 mg/m2 given every 3 weeks for 6 cycles

Sponsors & Collaborators

  • Movember Foundation

    collaborator OTHER

  • Prostate Cancer Research Alliance

    collaborator UNKNOWN

  • United States Department of Defense

    collaborator FED

  • Advanced Accelerator Applications

    collaborator INDUSTRY

  • Australia's Nuclear Science and Technology Organisation (ANSTO)

    collaborator UNKNOWN

  • Australian and New Zealand Urogenital and Prostate Cancer Trials Group

    collaborator OTHER

  • Australasian Radiopharmaceutical Trials network (ARTnet)

    collaborator UNKNOWN

  • Centre for Biostatistics and Clinical Trials (BaCT)

    collaborator UNKNOWN

  • Peter MacCallum Cancer Centre, Australia

    lead OTHER

Principal Investigators

  • Arun Azad, MBBS PhD FRACP · Peter MacCallum Cancer Centre, Australia

  • Michael Hofman, MBBS(Hons),FRACP,FAANMS,FICIS · Peter MacCallum Cancer Centre, Australia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-21
Primary Completion
2026-03-31
Completion
2026-03-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

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 NCT04343885 on ClinicalTrials.gov