Bipolar hormone therapy shows promise in stubborn prostate cancer

NCT ID NCT04558866

Ongoing Disease control Sponsor: Latin American Cooperative Oncology Group Source: ClinicalTrials.gov ↗

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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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.

PROSTATE CANCER

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

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