Bipolar hormone therapy shows promise in stubborn prostate cancer

NCT ID NCT04558866

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial is testing a combination of two hormone-based drugs—darolutamide and high-dose testosterone—in 51 men with metastatic castration-resistant prostate cancer, a form that no longer responds to standard hormone therapy. The approach, called extreme bipolar androgen therapy, aims to control cancer growth by cycling between blocking and flooding the body with male hormones. The main goal is to see how long the cancer stays under control without spreading.

What this could mean

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

Active substance

darolutamide and testosterone cypionate

What this could lead to

If successful, this could offer a new treatment option for men with advanced prostate cancer that has stopped responding to standard hormone therapy.

What could go wrong

This is a small, early-phase trial with only 51 participants and no comparison group. The combination may cause side effects or fail to control the cancer long-term.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma metastatic prostate carcinoma prostate cancer

As listed by the trial registrant

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

Contacts and locations

Locations

  • CTTB - Centro de Tratamento de Tumores Botafogo (Oncoclínicas)

    Rio de Janeiro, Rio de Janeiro, 22.250-905, Brazil

  • HIAE - Hospital Israelita Albert Einstein

    São Paulo, São Paulo, 05.653-000, Brazil

  • HMV - Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90.035-000, Brazil

  • Hospital São Rafael - Oncologia D'Or BA

    Salvador, Estado de Bahia, 41.253-190, Brazil

  • Hospital Sírio-Libanês DF

    Brasília, Federal District, 70.200-730, Brazil

  • Hospital Sírio-Libanês SP

    São Paulo, São Paulo, 01.308-050, Brazil