New trial combines drugs with surgery or radiation to fight advanced prostate cancer

NCT ID NCT05649943

Recruiting now Disease control Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This Italian study is testing whether adding local treatment (radiotherapy or surgery) to standard apalutamide and hormone therapy can delay cancer progression in men with metastatic hormone-sensitive prostate cancer. About 566 participants will first receive drug therapy for 6 months, then be randomly assigned to continue drugs alone or add local treatment. The main goal is to see if the combination improves progression-free survival.

What this could mean

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

Active substance: Apalutamide (Erleada) plus androgen deprivation therapy (hormone therapy), with or without local treatment (radiotherapy or radical prostatectomy)
What this could lead to: If successful, this could show that adding local treatment to standard drug therapy helps control metastatic prostate cancer longer, potentially improving survival without worsening side effects.
What could go wrong: This is a Phase 2/3 trial with 566 participants, but it is not yet complete. Adding local treatment may increase side effects without clear benefit, and results may not apply to all patients with metastatic prostate cancer.

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.

metastatic prostate carcinoma

As listed by the trial registrant

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

METASTATIC HORMONE-SENSITIVE PROSTATE CANCER (MHSPC)

Contacts and locations

Locations

ASST Santi Paolo e Carlo
NOT_YET_RECRUITING

Milan, Lombardy, 20153, Italy
European Institute of Oncology
NOT_YET_RECRUITING

Milan, Lombardy, 20141, Italy
Istituto Tumori Milano
RECRUITING

Milan, Mi, 20156, Italy

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