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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

162

Participants

Timeline

Start Date

August 17, 2020

Primary Completion Date

July 31, 2024

Study Completion Date

January 1, 2025

Conditions
Metastatic Castration-Resistant Prostate Cancer
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.

Trial Locations (15)

2010

St Vincents Hospital, Darlinghurst

2050

Chris O'Brien Lifehouse, Camperdown

2065

Northern Cancer Institute, Sydney

2109

Macquarie University Hospital, Macquarie Park

2170

Liverpool Hospital, Liverpool

2217

St George Hospital, Kogarah

2298

Calvary Mater Newcastle, Newcastle

3002

Peter MacCallum Cancer Centre, Melbourne

3004

The Alfred Hospital, Melbourne

3084

Austin Health, Heidelberg

3168

Monash Health, Clayton

4029

Royal Brisbane and Women's Hospital, Brisbane

5000

Royal Adelaide Hospital, Adelaide

6009

Sir Charles Gairdner Hospital, Nedlands

6150

Fiona Stanley Hospital, Perth

Sponsors
All Listed Sponsors
collaborator

National Health and Medical Research Council, Clinical Trials Centre

UNKNOWN

collaborator

Prostate Cancer Research Alliance

UNKNOWN

collaborator

Endocyte

INDUSTRY

collaborator

Astellas Pharma Inc

INDUSTRY

lead

Australian and New Zealand Urogenital and Prostate Cancer Trials Group

OTHER

NCT04419402 - Enzalutamide With Lu PSMA-617 Versus Enzalutamide Alone in Men With Metastatic Castration-resistant Prostate Cancer | Biotech Hunter | Biotech Hunter