MedTrace Logo

A Trial of 177Lu-PSMA617 Theranostic Versus Cabazitaxel in Progressive Metastatic Castration Resistant Prostate Cancer

NCT03392428 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2022-06-13

No results posted yet for this study

Summary

This open label, randomised, stratified, 2-arm, multicentre, phase 2 trial aims to determine the activity and safety of Lu-PSMA vs cabazitaxel in men with progressive metastatic castration resistant prostate cancer

Conditions

Interventions

OTHER

177Lu-PSMA617

Patients randomised to the 177Lu-PSMA617 arm will receive 6-8.5GBq of 177Lu-PSMA617 by intravenous injection once every 6 weeks until progressive disease, prohibitive toxicity or a maximum of 6 cycles. The first dose will be administered at 8.5GBq, reducing by 0.5GBq with every cycle given (i.e. to 6.0GBq on the sixth cycle, if reached). In some patients who have an exceptional response, treatment will be paused but can be re-commenced up to the maximum of 6 cycles upon progression.

DRUG

Cabazitaxel

Patients randomised to the Cabazitaxel arm will receive 20mg/m2 Cabazitaxel by intravenous infusion once every 3 weeks until progressive disease, prohibitive toxicity or a maximum of 10 cycles. Patients in this arm will also receive prednisolone 10mg orally per day for the duration of their cabazitaxel treatment.

Sponsors & Collaborators

  • Australian Nuclear Science and Technology Organisation (ANSTO)

    collaborator UNKNOWN

  • Endocyte

    collaborator INDUSTRY

  • Prostate Cancer Foundation of Australia (PCFA)

    collaborator UNKNOWN

  • Australasian Radiopharmaceutical Trials network (ARTnet)

    collaborator UNKNOWN

  • Movember Foundation

    collaborator OTHER

  • Australian and New Zealand Urogenital and Prostate Cancer Trials Group

    lead OTHER

Principal Investigators

  • Michael Hofman, A/Prof · Peter MacCallum Cancer Centre, Melbourne, Australia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-29
Primary Completion
2019-12-31
Completion
2021-12-31

Countries

  • Australia

Study Locations

More Related Trials

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 NCT03392428 on ClinicalTrials.gov