Recruiting

New drug combination with ultrasound therapy for advanced prostate cancer

Plain-English translation of NCT07172685 on ClinicalTrials.gov ↗ · Source last updated September 2025 · Translation generated July 2026 · How we translate trials

Read our Prostate Cancer research guide →

This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.

What is this trial?

This trial is testing whether a combination of three medications—darolutamide, docetaxel, and hormone therapy—works better when combined with a specialized ultrasound procedure called HIFU (high-intensity focused ultrasound) to treat advanced prostate cancer that has spread to the bones or other organs. The ultrasound therapy directly targets cancer cells in the prostate using focused sound waves. Researchers want to see if this combination can help men live longer and delay disease progression.

Advanced prostate cancer that has spread is very difficult to treat, and current standard treatments can cause significant side effects. This trial is exploring whether adding the focused ultrasound procedure to the medication combination might improve outcomes and give patients better control of their cancer.

Do you qualify?

You likely qualify if…

you are 18 years or older and male
you have been diagnosed with advanced prostate cancer that has spread to at least 4 bones (with at least one outside the pelvis) or to other organs
your cancer is still sensitive to hormone-blocking therapy and you have not been on these medications for more than 3 months
you are in good enough health to tolerate the treatments (ECOG performance status 0–1)
your blood counts, liver function, and kidney function are adequate for treatment

You likely don't qualify if…

you have already been treated with similar medications like apalutamide, enzalutamide, darolutamide, or abiraterone
you have had previous chemotherapy or immunotherapy for prostate cancer
you have had rectal surgery, a rectal fistula, or rectal narrowing that would make the ultrasound procedure unsafe
you have severe heart disease, recent heart attack, or unstable angina
you are allergic or intolerant to any of the study medications

What participation looks like

You would receive three medications (taken by mouth and by infusion) combined with a transrectal ultrasound procedure that targets the prostate cancer directly. The study runs from 2022 to 2025, and you would have regular clinic visits for blood work, imaging scans, and health monitoring to track how well the treatment is working and manage any side effects. Your doctor will adjust your medication doses if needed based on how you respond and any side effects you experience.

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

Trial locations(1 site)

China

Qilu hospital, Jinan, Shandong