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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age15-39
SponsorKarolinska Institutet

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

No trial groups listed

Locations

This trial has no locations

Sponsors and collaborators

Karolinska Institutet

Lead sponsor

Karolinska University Hospital

Collaborator

University of Edinburgh

Collaborator

University of Florence

Collaborator

Linkoeping University

Collaborator

Heidelberg University

Collaborator

Medical University Innsbruck

Collaborator

Ospedale Policlinico San Martino

Collaborator

University of Tartu

Collaborator

University of Leipzig

Collaborator

University of Bern

Collaborator

Université Libre de Bruxelles

Collaborator

Region Stockholm

Collaborator

University of Padova

Collaborator

University of Roma La Sapienza

Collaborator

University Hospital, Rouen

Collaborator

Fundacio Puigvert

Collaborator

Semmelweis University

Collaborator

Lund University

Collaborator

KU Leuven

Collaborator