carcinoma prostata metastasi

Innovative therapy against prostate cancer. Green light from Aifa

The TITAN project, with Sapienza as Italian coordinator, has identified a new treatment for metastatic prostate cancer. After the European and American regulatory bodies, the Italian Medicines Agency (Aifa) has also approved its prescriptibility and reimbursability

Prostate cancer is the most frequent cancer in men, and it is difficult to diagnose, especially in its early stages. It cannot be detected with a simple ultrasound scan but requires thorough urological examinations and periodic monitoring of prostate-specific antigen (PSA), an enzyme that maintains the fluidity of seminal fluid and whose quantity increases in prostate cancer.

The TITAN project, coordinated in Italy by Alessandro Sciarra of the Maternal Infantile and Urological Sciences Department of Sapienza, has demonstrated the benefits of a new systemic therapy with apalutamide for the treatment of metastatic prostate cancer. This multicentre and international research has been the subject of several publications in the prestigious New England Journal of Medicine.

Now even the Italian Medicines Agency (Aifa) has approved the new therapy, after validation by the US Food and Drug Administration (FDA) and the European Medicines Agency (Ema), providing for the use of apalutamide, a compound capable of inhibiting the biological effects of androgens.

'About 15 % of prostate cancers,' says Alessandro Sciarra, 'present at first diagnosis already in the metastatic phase and 20 % progress more or less slowly with the development of metastases after primary treatment. The TITAN study introduced an alternative treatment modality for this carcinoma to the classic therapy with pharmacological castration alone, which has produced a significant advantage for patients in terms of overall survival and quality of life'.

In addition to slowing tumour progression and prolonging patient survival, this new treatment scheme has excellent tolerability and relatively simple clinician management.

'With the recent approval by the regulatory bodies Ema and Aifa, this new treatment,' continues Alessandro Sciarra, 'can now be prescribed and reimbursed by accessing the hospital pharmacies of the institutions that are in charge of patients.

'The results obtained with this project allow patients with metastatic and hormone-sensitive prostate cancer, both at first diagnosis and progressive' Alessandro Sciarra concludes, 'to implement their therapeutic possibilities and thus represent an advantageous alternative to current therapies".


Further Information

Alessandro Sciarra
Department of Maternal Infantile and Urological Sciences

Tuesday, 26 July 2022

© Sapienza Università di Roma - Piazzale Aldo Moro 5, 00185 Roma - (+39) 06 49911 - CF 80209930587 PI 02133771002