Real-World data sought on triple therapy for Low-Volume prostate cancer

NCT ID NCT06661122

Recruiting now Knowledge-focused Sponsor: Bayer Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This observational study will follow 100 Japanese men with low-volume metastatic hormone-sensitive prostate cancer who are receiving darolutamide plus standard hormone therapy and chemotherapy. Researchers will collect medical records to see how many men achieve very low PSA levels after one year and track any side effects. The goal is to gather real-world safety and effectiveness data to guide treatment choices.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Darolutamide (a drug that blocks androgen signals) combined with androgen deprivation therapy (ADT, a hormone therapy) and docetaxel (a chemotherapy drug)
What this could lead to: If successful, this study could provide real-world evidence on how well this approved combination works and is tolerated in low-volume mHSPC, helping doctors make better treatment decisions.
What could go wrong: This is an observational study, not a controlled trial, so results may be influenced by patient selection and routine care variations. It is also limited to Japanese men, so findings may not apply to other populations.

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Conditions

The condition(s) this trial relates to.

metastatic prostate carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

LOW-VOLUME METASTASIS METASTATIC HORMONE-SENSITIVE PROSTATE CANCER (MHSPC)

Contacts and locations

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Study contacts

Contact

Phone: •••-•••-•••• Email: •••••@•••••

Locations

Many locations
RECRUITING

Multiple Locations, Japan

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