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

This trial does not accept healthy volunteers

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 population

Multi-center study on European AYA patient cohorts. Prospective observational multicohort study including male AYA cancer patients enrolled after a diagnosis of primary cancer and followed at 1, 2 and 3 years post diagnosis. The cohort database will be maintained to allow additional follow-up \>3 years after reconsent to allow for further longitudinal research. The subjects will be recruited at \~16 European Centres with expertise in oncofertility.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Constitution of a harmonized RedCap database

Time frame
June 2030
2

Incidence of azoo/oligozoo/normozoospermia according to the type of cancer treatment.

Time frame
June 2030
3

Incidence of overt and compensated hypogonadism according to the type of cancer treatment through the measurement of Testosterone, LH, FSH (Inhibin B) pre/post treatment.

Time frame
June 2030
4

Correlation between hormonal values /routine sperm parameters and clinical characteristics (testis volume, andrological history) at baseline with the development of azoo/oligozoospermia and/or hypogonadism post-therapy according to the type of treatment.

Time frame
June 2030

Secondary outcomes

1

Frequency of severe sperm DNA fragmentation according to the type of cancer treatment at different time points (pre- and post-therapy)

Subcohort 1

Time frame
June 2030
2

Frequency of alterations in sperm DNA methylation (target genes)

Subcohort 1

Time frame
June 2030
3

Whole-genome sequencing database including data from subset of patients

Subcohort 2

Time frame
June 2030
4

Database of validated genetic loci and associated with risk of persistent azoo/oligozoospermia and hypogonadism

Subcohort 2

Time frame
June 2030

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

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