Tyrosine kinase inhibitors and erectile dysfunction in men with chronic myeloid leukemia
A Potential Relationship Between Treatment With Tyrosine Kinase Inhibitors and Erectile Dysfunction in Male Patients With Chronic Myeloid Leukemia
This will see if taking tyrosine kinase inhibitors for chronic myeloid leukemia is linked to erectile dysfunction in adult men.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 350 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Male |
| Sponsor | Azienda USL Reggio Emilia - IRCCS Government |
| Drugs / interventions | imatinib, nilotinib, dasatinib, bosutinib, ponatinib |
| Locations | 1 site (Reggio Emilia, RE) |
| Trial ID | NCT07061145 on ClinicalTrials.gov |
What this trial studies
This is a national, multicenter observational study with retrospective and prospective parts that follows adult men with chronic‑phase Philadelphia chromosome–positive CML who started frontline TKI therapy between January 1, 2015 and January 31, 2022. Retrospective data will be collected from medical records on ED onset, cardiac tests, lab results, and BCR-ABL levels, and participants will be followed prospectively for up to 24 months to monitor new ED, cardiovascular events, and resolution after stopping therapy. The study compares incidence across TKIs (imatinib, dasatinib, nilotinib, bosutinib, ponatinib) and explores links between ED and cardiovascular toxicity as well as reversibility in patients who reach treatment‑free remission. No extra tests beyond routine clinical care are required, and about 350 patients are expected to be enrolled.
Who should consider this trial
Good fit: Adult men (aged 18–75) with chronic‑phase Ph+ or BCR‑ABL+ CML who started frontline TKI therapy between 01‑Jan‑2015 and 31‑Jan‑2022 and who did not have ED before starting TKIs are ideal candidates.
Not a fit: Patients in accelerated or blastic phase CML, men who had erectile dysfunction before starting TKI therapy, women, or those outside the specified treatment dates are unlikely to benefit from this study's findings.
Why it matters
Potential benefit: If successful, the study could clarify whether specific TKIs increase ED risk and help doctors counsel patients and choose therapies with fewer sexual side effects.
How similar studies have performed: Some case reports and small series have noted sexual side effects with TKIs, but large, systematic observational studies on ED incidence with modern TKIs are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients diagnosed with chronic phase Philadelphia chromosome-positive (Ph+) and/or BCR-ABL-positive CML. * Patients starting frontline treatment with TKIs between 01st January 2015 and 31st January 2022. * Age greater than or equal to 18 years and not exceeding 75 years at the time of starting therapy. * Male sex. * Exposure to Hydroxyurea or Anagrelide before the initiation of TKI therapy is allowed * Ability to provide informed consent, as demonstrated by a clear understanding of the study's objectives and procedures and the ability to make an informed and voluntary decision to participate * Signed written informed consent according to ICH/EU/GCP and national and local laws. Exclusion Criteria: * Patients with advanced phases (accelerated or blastic phase) Ph+ and/or BCR-ABL+ CML * Patients who experienced ED before TKI initiation
Where this trial is running
Reggio Emilia, RE
- Azienda USL IRCCS di Reggio Emilia — Reggio Emilia, Re, Italy (Recruiting)
Study contacts
- Principal investigator: Isabella Capodanno, MD — Azienda USL - IRCCS di Reggio Emilia
- Study coordinator: Isabella Capodanno, MD
- Email: isabella.capodanno@ausl.re.it
- Phone: 0522295511
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.