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

Starting soon

Conditions studied: Cancer, Reproduction, Infertility, Late Effects

In brief

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.

Key facts

Study ID

NCT07612943

Run by

Karolinska Institutet

People needed

1000

Starts

2026-06-01

Expected to finish

2031-05-31

Last updated by the study team

2026-05-29

Who can join

Age: 15 and older, up to 39. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Subjects with male internal and external genitalia
• Age at cancer diagnosis 15-39 years old
• Subjects planned to or having received oncologic treatment
• Subjects able to provide semen sample
• Information available on cancer treatment and medical history
• Patients (or parents in case of minors) who signed informed consent

You may not qualify if…

• individuals presenting with relapse or secondary cancers at time of inclusion
• subjects who were not treated with oncological treatment
• subjects who underwent bilateral orchiectomy
• patients with a diagnosis of azoospermia or testicular failure previously to cancer diagnosis

Full record on ClinicalTrials.gov

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