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

PHASE2CompletedINTERVENTIONAL
Enrollment

201

Participants

Timeline

Start Date

January 29, 2018

Primary Completion Date

December 31, 2019

Study Completion Date

December 31, 2021

Conditions
Cancer of the ProstateMetastatic Cancer
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."

Trial Locations (11)

2010

St Vincent's Hospital, Sydney

2065

Royal North Shore Hospital, Sydney

2170

Liverpool Hospital, Liverpool

2298

Calvary Mater Newcastle Hospital, Waratah

3008

Peter MacCallum Cancer Centre, Melbourne

3084

Austin Hospital, Melbourne

3165

Monash Moorabbin Hospital, Moorabbin

4029

Royal Brisbane and Womens Hospital, Brisbane

5000

Royal Adelaide Hospital, Adelaide

6009

Sir Charles Gairdner Hospital, Nedlands

6450

Fiona Stanley Hospital, Murdoch

Sponsors
All Listed Sponsors
collaborator

Australian Nuclear Science and Technology Organisation (ANSTO)

UNKNOWN

collaborator

Endocyte

INDUSTRY

collaborator

Prostate Cancer Foundation of Australia (PCFA)

UNKNOWN

collaborator

Australasian Radiopharmaceutical Trials network (ARTnet)

UNKNOWN

collaborator

Movember Foundation

OTHER

lead

Australian and New Zealand Urogenital and Prostate Cancer Trials Group

OTHER

NCT03392428 - A Trial of 177Lu-PSMA617 Theranostic Versus Cabazitaxel in Progressive Metastatic Castration Resistant Prostate Cancer | Biotech Hunter | Biotech Hunter