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NOT YET RECRUITING
NCT07612943

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

Sponsor: Karolinska Institutet

View on ClinicalTrials.gov

Summary

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.

Official title: Frequency and Prediction of Therapy-induced Testicular Dysfunction in AYA Cancer Survivors (ProspectiveMaleAYA)

Key Details

Gender

MALE

Age Range

15 Years - 39 Years

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2026-06-01

Completion Date

2031-05-31

Last Updated

2026-05-29

Healthy Volunteers

No