ENZA-p Trial

Trial Title:

A randomised phase II trial using PSMA as a therapeutic agent and prognostic indicator in men with metastatic castration-resistant prostate cancer treated with enzalutamide.

Trial Acronym:

ENZA-p

Protocol Number:

ANZUP 1901

Trial Design:

Phase 2, randomised, 2-arm, multicentre, open-label trial
Sponsor: ANZUP Cancer Trials Group Ltd

Collaborators: 
 

Prostate Cancer Research Alliance (PCRA)

Movember Foundation
Cancer Australia
Endocyte - a Novartis company
Astellas
Australasian Radiopharmaceutical Trials Network (ARTnet)
St Vincent’s Clinic Foundation
Roy Morgan Research
GenesisCare
ANSTO
MIM Software

ANZ Study Chairs:

Prof Louise Emmett, St Vincent’s Hospital, Sydney

ANZ Coordinating Centre:

NHMRC Clinical Trials Centre

Trial Coordinator:

Ailsa Langford

Trial Email:

enza-p@ctc.usyd.edu.au

Recruitment Aim:   160 participants 

Patient Population:

Men with mCRPC not previously treated with docetaxel for castration-resistant disease, suitable for treatment with enzalutamide and Lu-PSMA.

Intervention:

Enzalutamide 160 mg daily orally, continued until disease progression or prohibitive toxicity, PLUS Lu-PSMA (7.5 GBq) on days 15 and 57, with 2 additional doses following central review based on a repeat 68Ga-PSMA PET/CT on day 92 (experimental group).
OR
Enzalutamide 160 mg daily orally, continued until disease progression or prohibitive toxicity (control group).

Primary Objective:

1. PSA Progression Free Survival (PFS, PCWG3)

Secondary Objectives:

2. Radiological PFS (RECIST 1.1 and PCWG3)
3. PSA response rate (PSA reduction of ≥50% from baseline)
4. Pain response and PFS (PPI scale)
5. Clinical PFS (imaging, symptoms, initiation of new anticancer treatment)
6. Aspects of health-related quality of life (EORTC QLQ-C30,
Patient DATA Form, Fear of Cancer Progression short form)
7. Frequency and severity of adverse events (CTCAE v 5.0)

 Tertiary Objectives: 8. Overall survival (death from any cause)
9. Resource use and incremental cost-effectiveness
10. To identify biomarkers from imaging, blood, and tissue associated with prognosis, response to treatment, and/or safety, including:
i) 68Ga-PSMA PET/CT intensity up-regulation at baseline, Day 15, Day 92 and at first progression (PSA or radiological)
ii) Associations between quantitative 68Ga-PSMA PET/CT parameters (including 68Ga-PSMA PET avidity) and outcomes
iii) Associations between 68Ga-PSMA PET avidity to other predictive biomarkers in mCRPC (baseline characteristics, FDG PET/CT, CTC, AR-V7)
iv) Associations between clinical outcomes and other prognostic and/or predictive biomarkers (tissue and circulating), including circulating tumour cells (CTCs) and circulating tumour DNA (ctDNA)

Status:

Open and recruiting

Sites Recruiting:


NSW
Calvary Mater Newcastle
GenesisCare Northern Cancer Institute St Leonard's
St Vincent’s Hospital

VIC
Austin Health
Peter MacCallum Cancer Centre
The Alfred Hospital
 
QLD
Royal Brisbane
 
SA
Royal Adelaide Hospital
 
WA
Fiona Stanley Hospital

Further information:

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