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

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.

Conditions

• Cancer
• Reproduction
• Infertility
• Late Effects

Sponsors & Collaborators

• Karolinska University Hospital

  collaborator OTHER

• University of Edinburgh

  collaborator OTHER

• University of Florence

  collaborator OTHER

• Linkoeping University

  collaborator OTHER_GOV

• Heidelberg University

  collaborator OTHER

• Medical University Innsbruck

  collaborator OTHER

• Ospedale Policlinico San Martino

  collaborator OTHER

• University of Tartu

  collaborator OTHER

• University of Leipzig

  collaborator OTHER

• University of Bern

  collaborator OTHER

• Université Libre de Bruxelles

  collaborator OTHER

• Region Stockholm

  collaborator OTHER_GOV

• University of Padova

  collaborator OTHER

• University of Roma La Sapienza

  collaborator OTHER

• University Hospital, Rouen

  collaborator OTHER

• Fundacio Puigvert

  collaborator OTHER

• Semmelweis University

  collaborator OTHER

• Lund University

  collaborator OTHER

• KU Leuven

  collaborator OTHER

• Karolinska Institutet

  lead OTHER

Principal Investigators

• Kenny Rodriguez-Wallberg, Prof, MD · Karolinska Institutet

Eligibility

Min Age

15 Years

Max Age

39 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-01

Primary Completion

2030-05-31

Completion

2031-05-31