ENZA-p

 Prostate — Recruiting

ENZA-p
Enzalutamide is a potent hormone therapy that prevents testosterone from reaching prostate cancer cells, thereby stopping cancer growth. It is already widely used in men with prostate cancer that has stopped responding to standard hormone treatments (castration-resistant prostate cancer). However, most cancers become resistant to enzalutamide over time, with almost 1 in 4 being resistant from the start of treatment. Many prostate cancers, in particular those that have spread or become resistant to hormonal therapies, have a substance on their cell surface called prostate specific membrane antigen (PSMA). Lutetium-177 PSMA (Lu-PSMA for short) is a new treatment in advanced prostate cancer. Lu-PSMA is a radioactive molecule that attaches to the surface of prostate cancer cells throughout the body. This drug is given as an injection through the vein and allows targeted radiation to be delivered directly to prostate cancer cells. Smaller pre-clinical studies have demonstrated synergistic effects by combining Lu-PSMA with enzalutamide. It is possible that Lu-PSMA can prevent early resistance to enzalutamide, extending the time that men benefit from treatment. The ENZAp clinical trial aims to compare the effectiveness of enzalutamide in combination with Lu-PSMA, versus enzalutamide alone for the treatment of prostate cancer. This is a randomised study, so half the men in this trial will be randomly allocated to receive Lu-PSMA and enzalutamide, and the other half will be randomly allocated to receive enzalutamide alone. We plan to enroll 160 participants across Australia.
If you think this trial might be right for you, please ask your doctor.
If you think this trial might be right for you, please ask your doctor.
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.
Cancer Type
Prostate
Trial Status
Recruiting
Protocol Number
ANZUP 1901
Co-ordinating centre
Study Chair
Professor Louise Emmett
Patient Population
Men with mCRPC not previously treated with docetaxel for castration-resistant disease, suitable for treatment with enzalutamide and Lu-PSMA.
Recruitment Target
160 participants
Acknowledgements
The ENZA-p Trial is an investigator-initiated trial led by ANZUP in partnership with the Prostate Cancer Research Alliance (PCRA): An Australian Government and Movember Joint Initiative. ENZA-p is a collaboration between ANZUP, the NHMRC Clinical Trials Centre at the University of Sydney and the Australasian Radiopharmaceutical Trials Network (ARTnet) with support from Endocyte – a Novartis Company, St Vincent’s Clinic Foundation, Genesis Care, Roy Morgan Research, MIM Software Inc. and ANSTO. Astellas is providing drug support for the trial.
Detailed Information
Further Information
ClinicalTrials.gov
Participating Centres
NSW
Calvary Mater Newcastle
GenesisCare Northern Cancer Institute St Leonard's
St Vincent’s Hospital Sydney
Chris O'Brien Lifehouse - Sydney Local Health District
Liverpool Hospital - South Western Sydney Local Health District

VIC
Austin Health
Peter MacCallum Cancer Centre
Alfred Health - The Alfred Hospital
Monash Medical Centre

QLD
Royal Brisbane & Women's Hospital

SA
Royal Adelaide Hospital - Central Adelaide Local Health Network Inc.

WA
Fiona Stanley Hospital
Sir Charles Gairdner Hospital