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

NCT07612943 | Not Yet Recruiting DMC

• 2 other identifiers: v1.0-24/04/2026101214879
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (6)

• Constitution of a harmonized RedCap database

  June 2030

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

  June 2030

• 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.

  June 2030

• 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.

  June 2030

• Generation of risk categories for sub-fertility and/or hypogonadism

  June 2030

• Production of an evidence-based follow-up protocol according to risk categories identified.

  June 2030

Secondary Outcomes (12)

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

  June 2030

• Frequency of alterations in sperm DNA methylation (target genes)

  June 2030

• Whole-genome sequencing database including data from subset of patients

  June 2030

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

  June 2030

• Validated risk prediction models for chemotherapy induced effects on testicular function pre-post cancer treatment in relation to cancer diagnosis and therapy

  June 2030

Eligibility Criteria

• Age: 15 Years - 39 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

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:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Karolinska University Hospital: collaborator
• University of Edinburgh: collaborator
• Linkoeping University: collaborator
• Heidelberg University: collaborator
• Medical University Innsbruck: collaborator
• University of Tartu: collaborator
• University of Leipzig: collaborator
• University of Bern: collaborator
• Region Stockholm: collaborator
• University of Padova: collaborator
• University Hospital, Rouen: collaborator
• Fundacio Puigvert: collaborator
• Lund University: collaborator
• KU Leuven: collaborator
• Université Libre de Bruxelles: collaborator
• University of Roma La Sapienza: collaborator
• University of Florence: collaborator
• Ospedale Policlinico San Martino: collaborator
• Semmelweis University: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Analysis of sperm DNA fragmentation (SDF) to evaluate the genetic integrity treatment In a subgroup of patients blood can be collected to assess the effect of genetic variation on cancer treatment outcomes. This study will also utilize two primary analytical frameworks: i) epigenetic clocks to determine biological age; and ii) mosaic loss of chromosome Y (mLOY) as a marker of genomic instability (Gonzalez et al, 2020). In total a patient could be asked to supply a maximum of 4 sperm samples and 5x5 ml blood.

MeSH Terms

Conditions

Neoplasms; Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Kenny Rodriguez-Wallberg, Prof, MD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kenny Rodriguez-Wallberg, Prof, MD

CONTACT

+46852481213; kenny.rodriguez-wallberg@ki.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study coordinator

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 29, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): May 31, 2030
• Study Completion (Estimated): May 31, 2031
• Last Updated: May 29, 2026

Record last verified: 2026-05