Testing high-dose testosterone with chemotherapy for advanced prostate cancer

Plain-English translation of NCT03522064 on ClinicalTrials.gov ↗ · Source last updated April 2026 · Translation generated June 2026 · How we translate trials

Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.

What is this trial?

This study is testing a combination treatment using testosterone injections (in a method called bipolar androgen therapy) paired with carboplatin chemotherapy. The trial focuses on men whose prostate cancer has become resistant to standard hormone-lowering treatments and who have specific DNA repair gene mutations. Researchers believe this combination may help the cancer become sensitive to treatment again and improve quality of life.

Most men with advanced prostate cancer eventually develop resistance to hormone therapy, and new treatment options are needed. Early research suggests that cycling testosterone levels combined with chemotherapy might work better in patients with certain genetic changes, but doctors need to test this approach carefully to understand who benefits most and how it affects the cancer.

Do you qualify?

You likely qualify if…

you have been diagnosed with advanced prostate cancer that has stopped responding to standard hormone therapy
you have a confirmed genetic mutation in DNA repair genes (either inherited or in your cancer cells)
your PSA levels are rising despite having very low testosterone levels from ongoing hormone treatment
you are in good overall health with adequate heart, liver, and kidney function
you have a tissue sample available from your cancer or are willing to have a biopsy taken
you are able to attend study visits and follow the treatment plan

You likely don't qualify if…

you have received platinum chemotherapy or PARP inhibitor drugs before (with limited exceptions)
you have severe pain from cancer spread requiring strong opioid painkillers
you have cancer spread to your brain or spinal cord that could be harmed by testosterone therapy
you have had a heart attack or unstable chest pain within the past 2 years
you have a history of blood clots or another cancer diagnosis within the past 5 years

What participation looks like

You would receive testosterone injections every 4 weeks along with your ongoing hormone therapy, plus carboplatin chemotherapy on a schedule determined by your doctor. You'll have blood tests and imaging scans to monitor how the cancer responds and track side effects. The study involves regular clinic visits to assess your health, quality of life, and how the treatment is working, with the goal of understanding whether this combination helps men with your type of cancer.

AI-generated summary from trial data · Jun 12, 2026 · Not medical advice

Trial locations(1 site)

Australia

Kinghorn Cancer Centre, St. Vincent's Hospital, Sydney, New South Wales