Actively Recruiting
Study on Tyrosine Kinase Inhibitor Treatment and Erectile Dysfunction in Adult Men with Chronic Myeloid Leukemia
Led by Azienda USL Reggio Emilia - IRCCS · Updated on 2026-08-07
350
Participants Needed
1
Research Sites
104 weeks
Total Duration
AI-Summary
What this Trial Is About
Chronic myeloid leukemia CML is a blood cancer caused by the Philadelphia chromosome, which activates the BCR-ABL1 tyrosine kinase. Treatment with tyrosine kinase inhibitors TKIs has transformed CML from a fatal disease into a manageable chronic condition for most patients, though long-term use raises concerns about side effects, including vascular events and hormonal changes that may affect testosterone levels and lead to erectile dysfunction ED. This study observes male patients with chronic-phase CML who started frontline treatment with TKIs such as imatinib, dasatinib, nilotinib, bosutinib, or ponatinib between 2015 and 2022. It includes both a retrospective review of medical records to collect past data on ED onset, lab tests, ECGs, and BCR-ABL levels, and a prospective follow-up over two years to monitor ED development, cardiovascular events, and possible ED resolution in patients stopping treatment. Participants will be monitored through their medical records and regular clinical evaluations during the two-year follow-up. Researchers will track the cumulative incidence of ED, associations between different TKI treatments and ED, ED reversibility, and cardiovascular toxicity. The study involves no extra procedures beyond standard care and aims to better understand the relationship between TKI therapy and ED in men with CML.
CONDITIONS
Brief Title
A Potential Relationship Between Treatment With Tyrosine Kinase Inhibitors and Erectile Dysfunction in Male Patients With Chronic Myeloid Leukemia
Research Team
I
Isabella Capodanno, MD
M
Maria Pina Faruolo
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