Prostate cancer, Europe approves therapy for metastatic patients

Prostate cancer, Europe approves therapy for metastatic patients


When prostate cancer spreads or becomes metastatic, but is newly diagnosed where the cancer has already spread, the disease is sensitive to hormones and androgen deprivation therapy (ADT) is the mainstay of treatment. Now for these patients there is a new opportunity for treatment: the European Commission has, in fact, authorized the marketing in the European Union of darolutamide, an oral androgen receptor inhibitor (ARi), plus androgen deprivation therapy (ADT) in combination to chemotherapy with docetaxel.

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The most common cancer in men

Prostate cancer is the most frequent in men in almost all northern and western European countries. “In 2022, 40,500 new diagnoses of prostate cancer were estimated in Italy, the most frequent in men,” he explains. Sergio Bracarda, president of the Italian Society of Uro-Oncology (SIUrO) and director of the Complex Structure of Medical and Translational Oncology and of the Oncology Department at the Santa Maria di Terni Hospital. Only 30% of men with metastatic hormone-sensitive prostate cancer (mHSPC) survive more than five years after diagnosis. Most men with mHSPC develop disease progression to castration resistance (mCRPC), a stage of disease with limited long-term survival.

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Metastatic hormone-sensitive prostate cancer

At the time of diagnosis, most men have localized cancer, which means that the cancer is limited to the prostate gland and can be treated with curative surgery or radiation therapy. In the event of a recurrence, when the disease spreads or becomes metastatic, or in the case of a new diagnosis where the cancer has already spread, the disease is sensitive to hormones and androgen deprivation therapy (ADT) is the mainstay of treatment. Current treatment options for men with metastatic hormone-sensitive prostate cancer (mHSPC) include hormone therapy, such as ADT, androgen receptor blockers plus ADT, or a combination of docetaxel and ADT chemotherapy. Despite treatment, the majority of patients with metastatic hormone-sensitive prostate cancer (mHSPC) progress to develop metastatic castration-resistant cancer (mCRPC), a disease condition characterized by high morbidity and limited survival.

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The Arasens studio

The new European Commission approval of darolutamide is based on positive results from the Phase III ARASENS study involving more than 1,300 patients and which were published in the New England Journal of Medicine. “The study – explains Bracarda – showed that darolutamide in combination with hormone therapy and chemotherapy significantly reduces the risk of death by 32.5% compared to androgen deprivation therapy and docetaxel, in patients with metastatic hormone-sensitive prostate cancer. The combination with darolutamide not only prolongs survival and almost doubles the progression of the disease, but also safeguards the quality of life, a fundamental aspect for patients affected by cancer in the metastatic phase”.

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Awaiting refund

Darolutamide was already approved in March 2020 by the European regulatory agency for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastases. “This new approval extends the use of darolutamide to a larger group of patients but, more importantly, it allows for the implementation of a new therapeutic strategy that significantly broadens the therapeutic perspectives for men affected by the disease and which allows physicians to improve clinical outcomes “, he claims Horace Caffo, director of oncology at the Santa Chiara Hospital in Trento. “The EMA authorization is the first step for the reimbursement of the drug in European countries and, therefore, also in Italy, where it would be desirable for it to be available as soon as possible”.

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Efficacy and tolerability

For patients with metastatic prostate cancer, the therapeutic scenario is constantly evolving as in few other sectors of oncology: it is completely different compared to just a few years ago thanks to the availability of increasingly effective weapons. “In the setting of metastatic castration-sensitive prostate cancer, in which darolutamide has the new indication – continues Caffo – most patients present with bone localizations with the possible presence of pain and increased risk of fractures. Darolutamide combines efficacy and tolerability: thanks to its peculiar chemical structure, on the one hand it is able to inhibit the growth of prostate cancer cells, but on the other it has a good tolerability profile as it does not impact on the daily life of the patients. This is of the utmost importance not only for the prognosis of our patients but also for maintaining their quality of life”.

The other studies

Darolutamide, co-developed by Bayer with Orion Corporation, is being studied in an extensive development program through three additional ongoing or planned clinical trials to explore its potential in patients with early to late stage prostate cancer. Among them, the Phase III ARANOTE study evaluates darolutamide and ADT versus ADT alone in mHSPC.


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