Testosterone, Cognition, Ageing, and Cancer

NCT03452436 | Completed DMC

• 1 other identifier: TCAC
• Study Type: observational
• Target: 133
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of the study is - in a prospective controlled design - to examine whether treatment-induced decreases in testosterone acts as a mechanism of cancer-related cognitive impairment (CRCI) in testicular and prostate cancer patients. Secondary aims are 1) to explore whether decreases in testosterone interacts with increasing age to cause more severe CRCI in older patients, 2) to explore underlying neurophysiological (brain morphology) mechanisms of CRCI, and 3) to evaluate selected genetic variants as possible moderators of CRCI.

Conditions

Cancer-related Cognitive Impairment

Keywords

Cancer-related Cognitive Impairment; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorder; Testosterone; Endocrinology; Testicular Cancer; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Global cognitive functioning

  Changes in global cognitive composite score as measured with neuropsychological tests specified under "Secondary Outcome Measures".

  Baseline and 6 months' follow-up

Secondary Outcomes (26)

• Visuospatial ability

  Baseline and 6 months' follow-up

• Visuospatial ability

  Baseline and 6 months' follow-up

• Visuospatial ability

  Baseline and 6 months' follow-up

• Visuospatial ability

  Baseline and 6 months' follow-up

• Processing speed

  Baseline and 6 months' follow-up

Study Arms (3)

Testicular cancer patients

Forty testicular cancer patients included after orchiectomy but prior to any further treatment.

Prostate cancer patients

Forty prostate cancer patients included prior to medical castration and radiotherapy.

Healthy controls

Forty age- and education-matched healthy controls (20 matched to testicular cancer patients, 20 matched to prostate cancer patients).

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men with testicular and prostate cancer seen at Aarhus University Hospital. Age- and education matched healthy controls recruited from the general population of Central Denmark Region.

You may qualify if:

• Confirmed diagnosis of testicular cancer
• Confirmed diagnosis of prostate cancer and prescription of medical castration and radiotherapy

You may not qualify if:

• Previous cancer disease
• Previous central nervous system disease
• Brain metastases
• Severe psychiatric disease (e.g., schizophrenia, major depressive disorder)
• Insufficient Danish proficiency for neuropsychological testing

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Testicular Neoplasms; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Mental Disorders; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders; Prostatic Diseases

Study Officials

• Cecilie D R Clausen, MSc

  Unit for Psychooncology & Health Psychology, Department of Oncology, Aarhus University

  PRINCIPAL INVESTIGATOR

• Robert Zachariae, Professor, DMSc

  Unit for Psychooncology & Health Psychology, Department of Oncology, Aarhus University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: March 2, 2018
• Study Start: February 12, 2018
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: March 25, 2020

Record last verified: 2019-04

Locations

DK (1)