Prostate — In Follow-up

The aim of this study is to see if combining ipilimumab and nivolumab (drugs that activate the body’s own immune response to kill cancer cells), with Lu-PSMA (a type of treatment called radionuclide therapy that can be used to treat prostate cancer by bringing radioactive atoms into the cancer cells), can further improve the anti-cancer effects of Lu-PSMA. It is thought that ipilimumab and nivolumab and Lu-PSMA may work together to treat prostate cancer. Lu-PSMA can potentially kill cancer cells and break up the tumour into small pieces that may be recognised by your immune system while ipilimumab and nivolumab helps activate the immune system to find and attack the cancer. This new treatment combination may lead to shrinkage or stabilisation of previously progressing tumours and therefore hopefully stop or reverse the growth of the cancer.
If you think this trial might be right for you, please ask your doctor.
Trial Title
Phase II Study of Radionuclide 177Lu-PSMA Therapy versus 177Lu-PSMA in Combination with Ipilimumab and Nivolumab for people with Metastatic Castration Resistant Prostate Cancer
Cancer Type
Trial Status
In Follow-up
Protocol Number
ANZUP 2001
Co-ordinating centre
Study Chair
A/Prof Shahneen Sandhu and Professor Louise Emmett (co-chair)
Study Objective

To determine the activity and safety of ipilimumab and nivolumab in combination with 177Lu-PSMA in patients with mCRPC.

Patient Population
People with metastatic prostate cancer progressing on androgen deprivation therapy and second-generation androgen receptor targeted agent and with PSMA avid disease (SUV max >15 at a single site, and SUV max >10 at all sites >10nm).
Primary Outcome

The primary endpoint of this study is PSA PFS at 1 year. PSA PFS is defined as the interval from the date of randomisation to the date of first evidence of PSA progression or the date of last known follow-up without PSA progression PSA PFS at 1 year is defined as the proportion of participants without PSA progression at 53 weeks after randomisation.

Recruitment Target
100 participants
The EVOLUTION Trial is an investigator-initiated trial sponsored and led by ANZUP. This trial has received funding in partnership with the Prostate Cancer Foundation of Australia, Bristol Myers Squibb and Novartis. This trial 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 MIM Software Inc. and ANSTO.
Further Information
Participating Centres
St Vincent's Hospital - Sydney
Calvary Mater Newcastle
St George Hospital - South Eastern Sydney Local Health District (SESLHD)

Peter MacCallum Cancer Centre
Austin Hospital
Austin Health

Royal Adelaide Hospital - Central Adelaide Local Health Network Inc.

Sir Charles Gairdner - North Metropolitan Health Service