177Lu-PSMA-617 Therapy and Olaparib in Patients With Metastatic Castration Resistant Prostate Cancer

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

July 9, 2019

Primary Completion Date

May 31, 2025

Study Completion Date

June 30, 2026

Conditions
Metastatic Castration Resistant Prostate Cancer (mCRPC)
Interventions
DRUG

Olaparib

"During dose escalation doses of olaparib that can be administered are 50mg BD D2-15, 100mg BD D2-15, 150mg BD D2-15, 200mg BD D2-15,250mg BD D2-15, 300mg BD D2-15, 200mg BD D4-14, 300mg BD D-4-14 or 400mg D-4-18 of a 42 day cycle for up to 6 cycles.~The recommended phase 2 dose of olaparib will be used in 2 consecutive dose expansion cohorts. The first cohort will received the recommended phase 2 dose of Olaparib on D4-14 of a 42 day cycle. Patients enrolled in the second dose expansion cohort will receive Olaparib continuously from cycle 1 day -4 to cycle 6 day 42."

COMBINATION_PRODUCT

177Lu-PSMA

A fixed 7.4Gbq administered activity of 177Lu-PSMA will be given 6 weekly for up to 6 cycles.

Trial Locations (2)

2010

St Vincent's Hospital Sydney, Sydney

3000

Peter MacCallum Cancer Centre, Melbourne

All Listed Sponsors
lead

Peter MacCallum Cancer Centre, Australia

OTHER