ProspectiveMaleAYA - Frequency and Prediction of Therapy-induced Testicular Dysfunction in AYA Cancer Survivors

This study describes the ProspectiveMaleAYA cohort, a multicentre, prospective, longitudinal European study designed to investigate the long-term impact of cancer and cancer treatments on reproductive and endocrine health in adolescent and young adult (AYA) male cancer patients. Addressing major gaps in standardized prospective data, particularly for long-term fertility, hypogonadism, and the effects of newer systemic therapies, the study will harmonize data collection across centres and follow patients from diagnosis through post-treatment survivorship. Comprehensive clinical, oncologic, reproductive, hormonal, biological, and patient-reported outcomes will be collected at predefined intervals to evaluate testicular dysfunction, fertility impairment, oligo/azoospermia, sexual health, and quality of life. Sub-cohorts will enable focused analyses of genetic and epigenetic sperm changes, whole-genome sequencing to identify susceptibility to reproductive and organ toxicity, accelerated aging markers following specific treatments, access to and satisfaction with fertility counselling, and sexual health dysfunctions. The overarching aim is to identify risk factors and predictive markers, develop individualized risk stratification and prediction models, and support precision, patient-centred survivorship care for male AYA cancer survivors.

NCT Number	NCT07612943
Lead Sponsor	Karolinska Institutet Collaborators: Karolinska University Hospital, University of Edinburgh, University of Florence, Linkoeping University, Heidelberg University, Medical University Innsbruck, Ospedale Policlinico San Martino, University of Tartu, University of Leipzig, University of Bern, Université Libre de Bruxelles, Region Stockholm, University of Padova, University of Roma La Sapienza, University Hospital, Rouen, Fundacio Puigvert, Semmelweis University, Lund University, KU Leuven
Conditions	Cancer, Reproduction, Infertility, Late Effects
Enrollment	1,000 participants
Start Date	2026-06-01
Primary Completion	2030-05-31 (estimated)
Study Completion	2031-05-31 (estimated)
Updated on ClinicalTrials.gov	2026-05-29