ENZA-p

Current Clinical Trials

Prostate — In Follow-up

Enzalutamide is a potent hormone therapy that prevents testosterone from reaching prostate cancer cells, thereby stopping cancer growth. It is already widely used in people 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 people benefit from treatment.

The ENZA-p 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 people in this trial were randomly allocated to receive Lu-PSMA and enzalutamide, and the other half were randomly allocated to receive enzalutamide alone. There are 160 participants enrolled in this trial across Australia.

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 people with metastatic castration-resistant prostate cancer treated with enzalutamide.

CONSUMER TITLE

Study testing whether adding a targeted radiation treatment (LuPSMA) to enzalutamide improves outcomes, and whether PSMA can help monitor disease progression in people with advanced prostate cancer that no longer responds to hormone therapy. Participants are randomly assigned to different treatment groups.

CANCER TYPE

Prostate

TRIAL STATUS

In Follow-up

PROTOCOL NUMBER

ANZUP 1901

CO-ORDINATING CENTRE

NHMRC Clinical Trials 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

ACKNOWLEDGEMENT

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.