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Prostate CancerABCNCT05820932

Predicting Cognitive Decline From Androgen Deprivation Therapy

An observational study of Prostate Cancer, run by University of California, San Francisco at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Blood-based assay, Cognitive assessments and Quality of Life Surveys
How many people
32 participants
Where
1 siteUnited States
Study dates
22 May 2023to 30 Apr 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants with prostate cancer and partners of participants. The analysis population will consist of participants who complete baseline plasma Aβ42/40 and apolipoprotein E4 (APOE4) collection and the cognitive assessments at baseline and at least 3 months.

Who may be able to join

  • Patient Participants-
  • 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.
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  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (documented within past 3 months, otherwise patient-reported).
  • Study partner participants-
  • 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.
  • Only the ADT cohort-
  • 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.
  • Only the PC cohort-
  • 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.

Who cannot join

  • Patient Participants-
  • 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).
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  • 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.
  • Study partner participants-
  • None.
  • Only the ADT cohort-
  • None.
  • Only the PC cohort-
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California, San Francisco

    San Francisco, California, 94143

Other trials in United States

About this study

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

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.

Read the detailed description

This is a single-site, non-randomized prospective observational study of men with prostate cancer.

PRIMARY OBJECTIVE:

  1. To evaluate whether baseline plasma Amyloid-beta 42/40 (Aβ42/40) ratio is associated with cognitive decline in men upon starting ADT.

SECONDARY OBJECTIVE:

  1. To evaluate whether ADT is associated with a decline in plasma Aβ42/40 ratio.

II. To evaluate whether intensified ADT (iADT) receipt is associated with greater cognitive decline compared to ADT.

Conditions
Prostate Cancer
Being tested
Blood-based assay, Cognitive assessments, Quality of Life Surveys
Keywords
Cognitive decline, Cognitive functioning
Medical subject headings
Prostatic Neoplasms, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood-based assayGenetic

    Blood samples will be collected

  • Cognitive assessmentsDiagnostic test

    Cognitive assessments will be both participant- and partner-reported

  • Quality of Life SurveysOther

    Also called QoL Surveys

    Participant-reported Quality of Life Surveys

Study groups in NCT05820932
Study groupRoleWhat they receive
Participants with prostate cancer, ADT (ADT Cohort)This group is comprised of adult men with hormone-sensitive prostate cancer who are starting androgen deprivation therapy as part of standard of care prostate cancer (not as part of this protocol).
Receives: Genetic: Blood-based assay; Diagnostic Test: Cognitive assessments; Other: Quality of Life Surveys
Participants in remission, No ADT (Prostate cancer Control (PC) Cohort))This group is comprised of adult men who are in remission from prostate cancer who have never received ADT.
Receives: Genetic: Blood-based assay; Diagnostic Test: Cognitive assessments; Other: Quality of Life Surveys
Partners of ParticipantsStudy partner participants will also be recruited
Receives: Other: Quality of Life Surveys

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants with cognitive decline (ADT cohort)

    Proportion with cognitive decline, defined as a decrease in >=1 neurocognitive test after ADT by >=1 standard deviation (SD) compared to baseline.

    Measured: Up to 12 months

  2. Mean cognitive decline (ADT cohort)

    The Z-scores of each cognitive test after receiving ADT will be calculated as a repeated measure.

    Measured: Up to 12 months

  3. Proportion of participants with cognitive impairment after ADT (ADT Cohort)

    Proportion of participants with cognitive impairment after receiving ADT, defined as a score of >=1 SD below normative mean score (i.e., PC control) in >=1 of the neurocognitive tests given during the course of ADT therapy.

    Measured: Up to 12 months

Secondary outcomes (3)

  1. Change in mean plasma Aβ42/40 ratio

    Change in mean plasma Aβ42/40 ratio for the ADT cohort at 12 months will be compared to that of the PC control cohort

    Measured: Up to 12 months

  2. Mean cognition score

    The Z-scores of each cognitive test will be calculated as a repeated measure.

    Measured: Up to 12 months

  3. Mean study partner-reported cognition score

    The Z-scores of each cognitive test will be calculated as a repeated measure.

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2023
  2. Study start22 May 2023
  3. Primary completion30 Apr 2026
  4. Study completion30 Apr 2026

Why it stopped: Slow Accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05820932
Sponsor's protocol ID
22806
Other IDs
NCI-2023-02192
Acronym
ABC
Status last verified
Apr 2026
First submitted
7 Apr 2023
Last updated
7 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Prostate Cancer, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Slow Accrual). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants with cognitive decline (ADT cohort) (time frame: Up to 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05820932.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.

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ABC Clinical Trial NCT05820932 | AzTrials