TheraP Trial

Trial Title:

A randomised phase II trial of 177Lu-PSMA617 theranostic versus cabazitaxel in progressive metastatic castration resistant prostate cancer

Trial Acronym:

TheraP

Protocol Number:

ANZUP 1603

Trial Design:

Open label, randomised, stratified, 2-arm, multicentre, phase 2 trial

Collaborators:

Prof Ian Davis

ANZ Study Chairs:

Assoc/Prof Michael Hofman

ANZ Coordinating Centre:

NHMRC CTC

Trial Coordinator:

Ailsa Langford

Trial Email:

therap@ctc.usyd.edu.au

Patient Population:

Men with mCRPC suitable for cabazitaxel chemotherapy.

Intervention:

Experimental: Lu-PSMA 6-8.5 GBq IV every 6 weeks until prohibitive toxicity, the patient is no longer thought to be benefiting, or post-therapy imaging with SPECT/CT shows complete resolution of PSMA uptake, to a maximum of 6 cycles. Treatment can be interrupted after an exceptional response, re-started at subsequent progression, and then continued to a maximum of 6 cycles in total.

Standard: Cabazitaxel 20mg/m2 IV every 3 weeks with prednisolone 10mg daily orally, continued until progressive disease or prohibitive toxicity to a maximum of 10 cycles.

Primary Outcome:

1. Prostate Specific Antigen (PSA) response rate (PSA reduction of ≥50% from baseline).

Secondary Outcomes:

2. Pain response (≥2 point reduction in PPI without increase in analgesic score) rate
3. Objective tumour response (OTR = CR or PR, RECIST 1.1and PCWG3) rate
4. Progression-Free Survival (PFS: time to PSA progression, pain progression, radiographic progression, or death)
5. PSA PFS (PCWG3)
6. Pain PFS (PPI and analgesia score)
7. Radiographic PFS (PCWG3 criteria for bone lesions and RECIST 1.1 for soft tissue lesions)
8. Aspects of health related quality of life (HRQL)
9. Overall survival (OS, death from any cause)
10. Frequency and severity of adverse events (CTCAE v 4.03)

Tertiary objectives of this study are to determine:
11. Associations between 68Ga-PSMA PET/CT, FDG PET/CT, baseline characteristics, and outcomes
12. Associations between clinical outcomes and possible prognostic and/or predictive biomarkers (tissue and circulating) including ctDNA

Status:

Active and recruiting

Sites Recruiting:

Victoria
Peter MacCallum Cancer Centre (open)
The Austin Hospital (estimated to open first/second quarter 2018)
Monash Medical Centre (estimated to open first quarter 2018)

NSW
St Vincent’s Hospital (estimated to open first/second quarter 2018)
Royal North Shore Hospital (estimated to open first quarter 2018)
Liverpool Hospital (estimated to open first quarter 2018)

Queensland 
Royal Brisbane and Women's Hospital (open)

Western Australia
Fiona Stanley Hospital (estimated to open first/second quarter 2018)
Sir Charles Gairdner Hospital (estimated to open first/second quarter 2018)

South Australia 
Royal Adelaide Hospital (estimated to open first/second quarter 2018)

Further Information:

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