RECRUITING

Predicting Cognitive Decline From Androgen Deprivation Therapy

Conditions

Prostate Cancer Cognitive decline Cognitive functioning

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Androgen Deprivation Therapy (ADT) is associated with cognitive impairment and dementia in men with prostate cancer. Pre-clinical data suggest that ADT-induced hypogonadism leads to accumulation of beta-amyloid plaques in the hippocampus, a pathological hallmark of Alzheimer's Disease (AD). Neuroimaging Functional magnetic resonance imaging (fMRI) studies also demonstrate that ADT decreases metabolic activity in the parietal, occipital, and prefrontal cortices. Multiple prospective cohort and population-based clinical studies have been conducted to test the association between ADT and cognitive impairment and/or dementia. Plasma biomarkers have been developed to predict brain amyloidosis, a key pathological feature of AD and a risk factor for developing dementia due to AD. The advantage of a blood-based assay is the lower cost, invasiveness, and time compared to cerebrospinal fluid (CSF) and Positron Emission Tomography (PET)-based biomarkers.

Official Title

Plasma Amyloid-beta 42/40 to Predict Cognitive Decline From Androgen Deprivation Therapy in Prostate Cancer: a Prospective Observational Study

Quick Facts

Study Start:2023-05-22

Study Completion:2026-05-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05820932

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age 18 years or greater. * Fluent in reading, listening to, and writing English. * Current or prior diagnosis of prostate adenocarcinoma based on a pathology report or as documented in a medical oncology, urology, or radiation oncology note. * Access and ability to use a computer or mobile device with Internet connectivity to complete study procedures. * Telephone Montreal Cognitive Assessment (T-MoCA) of 16 or greater. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (documented within past 3 months, otherwise patient-reported). * Age 18 years or greater * Fluent in reading, listening to, and writing English * Identified by patient participant as a person who knows patient participant well, like a friend, family member or spouse. * Access and ability to use a computer or mobile device with internet connectivity to complete study procedures. * Anticipated to start ADT, which includes one of the following two treatments * Gonadotropin-releasing hormone (GnRH) agonist (e.g., leuprolide, goserelin, and others). * GnRH antagonist (i.e., degarelix or relugolix). * Anticipated to remain on ADT for at least 12 months. * Concurrent first-generation anti-androgens (e.g., bicalutamide, flutamide, nilutamide) and novel androgen-signaling inhibitors (e.g., abiraterone, enzalutamide, and apalutamide) are allowed. * Concurrent radiation is allowed. * Has completed definitive local therapy (radical prostatectomy or radiation therapy) for localized prostate cancer at least 6 months prior to screening. * For radical prostatectomy: undetectable prostate-specific antigen (PSA) within 12 months of screening. * For radiation therapy: last PSA of \< 2.0 within 12 months of screening.	* Small cell prostate carcinoma (pure or mixed). * Receipt of ADT (GnRH agonist, GnRH antagonist, 1st-generation anti-androgen, or novel androgen signaling inhibitor) within 6 months before screening. ADT \>6 months prior to screening is allowed provided testosterone has recovered to 100 ng/ml or greater. * Concurrent or anticipated (at any point during first 12 months of ADT) non-hormonal, antineoplastic systemic therapy, such as chemotherapy. * Testosterone \<100 ng/ml. * Prior or concurrent brain metastases (no prior or screening imaging is required). * Major neurocognitive or psychiatric disorders, such as dementia or schizophrenia. * Prior or concurrent malignancy other than prostate cancer whose natural history or treatment has the potential to interfere with study assessments. * None. * None. * Any prior, concurrent, or anticipated use of any hormonal systemic therapy, including GnRH agonist, GnRH antagonist, 1st-generation anti-androgen, or novel androgen signaling inhibitor. * Any known or prior history of M1 prostate cancer (no screening imaging required). * Current or prior biochemical recurrence following American Urological Association guidelines for radical prostatectomy or American Society for Therapeutic Radiology and Oncology (ASTRO) guidelines for radiation therapy.

Inclusion Criteria

Exclusion Criteria

* Age 18 years or greater.
* Fluent in reading, listening to, and writing English.
* Current or prior diagnosis of prostate adenocarcinoma based on a pathology report or as documented in a medical oncology, urology, or radiation oncology note.
* Access and ability to use a computer or mobile device with Internet connectivity to complete study procedures.
* Telephone Montreal Cognitive Assessment (T-MoCA) of 16 or greater.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (documented within past 3 months, otherwise patient-reported).
* Age 18 years or greater
* Fluent in reading, listening to, and writing English
* Identified by patient participant as a person who knows patient participant well, like a friend, family member or spouse.
* Access and ability to use a computer or mobile device with internet connectivity to complete study procedures.
* Anticipated to start ADT, which includes one of the following two treatments
* Gonadotropin-releasing hormone (GnRH) agonist (e.g., leuprolide, goserelin, and others).
* GnRH antagonist (i.e., degarelix or relugolix).
* Anticipated to remain on ADT for at least 12 months.
* Concurrent first-generation anti-androgens (e.g., bicalutamide, flutamide, nilutamide) and novel androgen-signaling inhibitors (e.g., abiraterone, enzalutamide, and apalutamide) are allowed.
* Concurrent radiation is allowed.
* Has completed definitive local therapy (radical prostatectomy or radiation therapy) for localized prostate cancer at least 6 months prior to screening.
* For radical prostatectomy: undetectable prostate-specific antigen (PSA) within 12 months of screening.
* For radiation therapy: last PSA of \< 2.0 within 12 months of screening.

* Small cell prostate carcinoma (pure or mixed).
* Receipt of ADT (GnRH agonist, GnRH antagonist, 1st-generation anti-androgen, or novel androgen signaling inhibitor) within 6 months before screening. ADT \>6 months prior to screening is allowed provided testosterone has recovered to 100 ng/ml or greater.
* Concurrent or anticipated (at any point during first 12 months of ADT) non-hormonal, antineoplastic systemic therapy, such as chemotherapy.
* Testosterone \<100 ng/ml.
* Prior or concurrent brain metastases (no prior or screening imaging is required).
* Major neurocognitive or psychiatric disorders, such as dementia or schizophrenia.
* Prior or concurrent malignancy other than prostate cancer whose natural history or treatment has the potential to interfere with study assessments.
* None.
* None.
* Any prior, concurrent, or anticipated use of any hormonal systemic therapy, including GnRH agonist, GnRH antagonist, 1st-generation anti-androgen, or novel androgen signaling inhibitor.
* Any known or prior history of M1 prostate cancer (no screening imaging required).
* Current or prior biochemical recurrence following American Urological Association guidelines for radical prostatectomy or American Society for Therapeutic Radiology and Oncology (ASTRO) guidelines for radiation therapy.

Contacts and Locations

Study Contact

UCSF Genitourinary Medical Oncology Recruitment

CONTACT

877-827-3222

GUTrials@ucsf.edu

Principal Investigator

Daniel Kwon, MD

PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Study Locations (Sites)

University of California, San Francisco

San Francisco, California, 94143

United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

Daniel Kwon, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-22

Study Completion Date2026-05-31

Study Record Updates

Study Start Date2023-05-22

Study Completion Date2026-05-31

Terms related to this study

Keywords Provided by Researchers

Cognitive decline
Cognitive functioning

Additional Relevant MeSH Terms

Prostate Cancer