The ProstACT Global trial is a clinical research study for men with advanced prostate cancer that has spread beyond the prostate and progressed despite hormone therapy. The trial is looking at a targeted radioligand therapy, a treatment designed to deliver targeted radiation directly to cancer cells. The targeted therapy is being given alongside standard treatment and compared with standard treatment alone.
The goal is to find out whether adding this targeted therapy improves outcomes for men whose prostate cancer has progressed despite prior hormone treatment.
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Express your interest or find out more about the ProstACT Global trial
Who can take part?
You may be eligible to take part if you:
- Have had prostate cancer confirmed by biopsy
- Have cancer that has spread beyond the prostate (metastatic disease)
- Have cancer that continues to grow even though your testosterone levels are very low (castration-resistant)
- Have previously been treated for at least 12 weeks with a hormone therapy medicine that targets the androgen pathway, and your cancer has progressed despite this treatment
- Have had a PSMA PET scan showing that your cancer expresses PSMA, a protein commonly found on prostate cancer cells
Your treating doctor will confirm your eligibility based on the full trial criteria.
What does taking part involve?
If you are eligible and choose to take part:
- You will be randomly assigned to receive either the investigational targeted therapy alongside standard treatment, or standard treatment alone, similar to the toss of a coin
- You will have regular check-ups, scans and blood tests so the study team can monitor your safety and how you respond to treatment
- Your participation is entirely voluntary and you may withdraw at any time
- The trial is being run at cancer centres in multiple countries, including sites in Australia
Why participate?
By taking part in the ProstACT Global trial, you may be able to access an investigational treatment while being closely monitored by an experienced study team. Your participation may also contribute to research that could help improve treatment for people with advanced prostate cancer in the future.
There is no guarantee that you will benefit from participating or receive the investigational treatment. The study team will explain the potential benefits and risks before you decide whether to take part.
The trial is being run at cancer centres in multiple countries, including sites in Australia. GenesisCare is offering the trial at the following locations:
- NSW – Maitland (Hunter Valley)
- QLD – Tugun (John Flynn Private Hospital)
- SA – North Adelaide (Calvary North Adelaide Hospital)
- VIC – Cabrini Hospital, Malvern
- WA – Murdoch (St John of God Hospital)
We also welcome people who are able to travel to these locations and are interested in taking part.
If you or someone you care for has advanced prostate cancer, you can also speak with your radiation oncologist or medical oncologist about whether the ProstACT Global trial may be suitable.
For full trial information, including detailed eligibility criteria, see the trial registry listing: [insert ANZCTR / clinicaltrials.gov link].
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Express your interest or find out more about the ProstACT Global trial
ProstACT Global is a Phase 3 clinical research study looking at a targeted radioligand therapy, a treatment that delivers targeted radiation directly to cancer cells, given together with standard treatment and compared with standard treatment alone. It is currently recruiting and is expected to involve around 520 participants at cancer centres in multiple countries.
The trial is for men with metastatic castration-resistant prostate cancer: prostate cancer that has spread beyond the prostate and continues to grow even though testosterone levels are very low. Participants must have already been treated for at least 12 weeks with a hormone therapy medicine that targets the androgen pathway, and their cancer must have progressed despite this treatment.
Eligibility also requires a scan (a PSMA PET scan) confirming that the cancer expresses PSMA, a protein commonly found on prostate cancer cells, and that the diagnosis has been confirmed by biopsy. Your treating doctor can confirm whether you meet the full eligibility criteria.
The trial is studying a targeted radioligand therapy that is designed to seek out and bind to PSMA on prostate cancer cells and deliver radiation directly to them, while aiming to spare healthy tissue. It is given alongside standard treatment options such as hormone therapy tablets or chemotherapy.
No. The trial compares the investigational therapy plus standard treatment against standard treatment alone, and participants are assigned to a group at random, similar to the toss of a coin. Most participants who join the larger part of the study will be assigned to receive the investigational therapy, but this is not guaranteed for any individual.
Participation involves a PSMA PET scan to confirm eligibility, followed by regular visits for treatment (if assigned to the investigational therapy group), scans, blood tests and check-ups so the study team can monitor safety and how you respond to treatment. Some participants may also be asked to take part in longer-term follow-up to track outcomes over time.
As with any clinical trial, there may be side effects associated with the study treatment, and these will be explained in detail during the informed consent process before you agree to take part. Your study doctor will discuss the known and potential risks with you and monitor you closely for any side effects throughout the trial.
Trial-related treatments, tests and study visits are generally provided at no cost to participants. Your care team can confirm exactly what is and isn't covered before you decide whether to take part.
Yes. Taking part is entirely voluntary, and you are free to withdraw from the trial at any time, for any reason, without it affecting your ongoing medical care.
The trial is being conducted at cancer centres in multiple countries, including several GenesisCare centres across Australia and the United Kingdom, as well as sites in New Zealand, Canada, Turkey and the United States. Not all sites may be recruiting at the same time, so your treating doctor or the study team can advise which centres near you are currently open.
Participants will be involved in the trial for as long as their treatment is helping them, followed by regular check-ups. Some outcomes, such as overall survival, are tracked for up to 5 years after joining, so long-term follow-up is an important part of the study.
Yes. A family member or carer can submit an enquiry on behalf of someone with advanced prostate cancer. The GenesisCare team may need to speak directly with the person concerned and obtain their permission before discussing their health information or potential eligibility.
Speak with your treating radiation or medical oncologist about whether the ProstACT Global trial may be suitable for you, or complete the enquiry form on this page and a member of the GenesisCare team will contact you to discuss your potential eligibility and next steps.