Not yet recruitingPHASE2INTERVENTIONAL

Clinical Trial to Test Efficacy of Targeting Hypoxia Combined With ARSI After First-line ARSI Therapy for Castrate Resistant Prostate Cancer

This study is for men with prostate cancer that has spread and is no longer being controlled by standard hormone therapy (called ARSI treatment). The study aims to find out if adding a new drug, evofosfamide, to an alternative ARSI treatment is effective. Evofosfamide works by targeting areas in the cancer that have low oxygen. Participants will receive this new drug through a drip three times a month, along with their standard ARSI medicine. Doctors will closely monitor how participants respond to the treatment and check for any side effects. The study also includes scans and blood tests to understand the treatment's impact on the cancer.

At a glance

Status

Not yet recruiting

Phase

PHASE2

Sponsor

University Health Network, Toronto

Enrolment target

Start

27 May 2026

Estimated completion

27 May 2030

Castration Resistant Prostate Cancer

What is this study about?

This study is looking at a new way to treat prostate cancer that has spread to other parts of the body and is no longer responding to initial hormone treatments. This type of prostate cancer is called 'castration-resistant prostate cancer' (CRPC).

The main aim of this study is to see how well a new drug called evofosfamide works when given一緒に (together with) an existing prostate cancer medicine (known as an ARSI). Evofosfamide is designed to target cancer cells in low-oxygen areas, which can be found in some tumours. Researchers want to find out if combining these two treatments can be more effective for men whose initial ARSI treatment hasn't worked, and who may not be able to have (or have already had) other treatments like docetaxel.

Participants will receive a different ARSI medicine than the one they had first, along with evofosfamide. Doctors will closely watch how the cancer responds to this combination and check for any side effects. This involves regular scans, blood tests, and check-ups. The study aims to gather important information that could help improve future treatments for men with this type of prostate cancer.

Key takeaways

This study tests a new drug (evofosfamide) combined with a standard prostate cancer medicine (ARSI).
It's for men whose prostate cancer has spread and isn't responding to initial hormone therapy.
Participation involves regular hospital visits for drips, check-ups, blood tests, and scans.
The new drug targets cancer cells in low-oxygen areas.
The study aims to find more effective treatments for advanced prostate cancer.

Who may be eligible?

To join this study, you need to be at least 18 years old and have prostate cancer that has spread (M1) and is no longer responding to your first hormone treatment (ARSI). You also need to be currently on hormone therapy to keep your testosterone levels low.

Your general health will be checked to make sure you can safely take part. For example, your blood tests (like blood count, liver, and kidney function) need to be within certain ranges. If you have any major heart problems, or severe lung conditions that significantly affect your breathing, you might not be able to join.

Also, if you've had very serious side effects from your previous ARSI treatment, or if your blood test results show certain issues, you might not be eligible. The study team will review all your medical information carefully to see if this study is suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you at least 18 years old?
Do you have prostate cancer that has spread and is no longer controlled by your first hormone treatment (ARSI)?
Are you currently receiving treatment to keep your hormone levels low?
Are your general blood tests (like blood counts, liver, and kidney function) within healthy ranges?
Can you be monitored regularly for treatment and side effects?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll receive the study drug, evofosfamide, through a drip into your vein (intravenously) three times within each 28-day cycle. You'll also continue to take your prescribed ARSI medication. On days you receive both, your ARSI will be given at least two hours after your evofosfamide drip is finished.

Before starting, you'll have scans (PSMA and FDG PET/CT) and might be asked to have a biopsy of a tumour. Throughout the study, you'll have monthly visits. These visits will include check-ups, physical exams, and blood tests to monitor your health and any side effects. Every 8 weeks, you'll have full-body scans to see how the cancer is responding. You'll continue treatment until your cancer progresses, you experience unacceptable side effects, or you decide to stop. After treatment, you'll be followed up regularly to track your long-term health.

Potential risks and benefits

Taking part in a clinical trial may offer the potential benefit of accessing new treatments before they are widely available. However, there are also potential risks, as the study drug evofosfamide and the combination with ARSI may cause side effects, some of which could be serious or unexpected. Your doctors will monitor you closely for any adverse reactions throughout the study. Remember, participating is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (1)

Princess Margaret Cancer Center
Verified postcode
Toronto, Canada

Common questions

What is 'castration-resistant prostate cancer'?

It's prostate cancer that has continued to grow even when hormone treatments are trying to lower male hormones like testosterone.

What is an ARSI?

ARSI stands for Androgen Receptor Signalling Inhibitor. These are medicines that block the effects of male hormones on prostate cancer cells.

What does 'Phase 2' mean for this trial?

Phase 2 means the drug has been shown to be safe in a smaller group of people, and now researchers are looking more closely at how well it works and confirming safety in a larger group.

Will I still get my usual prostate cancer treatment?

Yes, you will continue to receive a standard ARSI treatment, but it will be a different one from your first ARSI, combined with the new study drug, evofosfamide.

How often will I need to go to the hospital?

You will have visits for treatment (drips) three times a month, and monthly check-ups for blood tests. Scans will be every 8 weeks.

How to find out more

Alejandro Berlin, MD

alejandro.berlin@uhn.ca 416-946-4501 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.