MedTrace Logo

Enzalutamide With Lu PSMA-617 Versus Enzalutamide Alone in Men With Metastatic Castration-resistant Prostate Cancer

NCT04419402 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2024-02-07

No results posted yet for this study

Summary

This phase 2 randomised clinical trial will investigate the activity and safety of adding Lu-PSMA to enzalutamide in patients with metastatic castrate resistant prostate cancer (mCRPC) not previously treated with chemotherapy.

Conditions

Interventions

DRUG

Lu-PSMA

Patients will be given 7.5 GBq of Lu-PSMA in 4 doses. Dose 1 and 2 on Days 15 and 57. Doses 3 and 4 (Days 113 and 169) will be given following result of 68Ga-PSMA PET/CT at Day 92. Treatment administered every 6 weeks, x 4 cycles.

DRUG

Enzalutamide

160 mg (four 40 mg capsules) daily.

Sponsors & Collaborators

  • National Health and Medical Research Council, Clinical Trials Centre

    collaborator UNKNOWN

  • Prostate Cancer Research Alliance

    collaborator UNKNOWN

  • Endocyte

    collaborator INDUSTRY

  • Astellas Pharma Inc

    collaborator INDUSTRY

  • Australian and New Zealand Urogenital and Prostate Cancer Trials Group

    lead OTHER

Principal Investigators

  • Louise Emmett, MBBS, FRACP · St Vincent's Hospital, Sydney

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-17
Primary Completion
2024-07-31
Completion
2025-01-01

Countries

  • Australia

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 NCT04419402 on ClinicalTrials.gov