Trials Sponsors Conditions Drugs Pricing

Conditions

Prostate Cancer

Keywords

Cognitive declineCognitive functioning

Outcome Measures

Primary Outcomes (3)

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.
Up to 12 months
Mean cognitive decline (ADT cohort)
The Z-scores of each cognitive test after receiving ADT will be calculated as a repeated measure.
Up to 12 months
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.
Up to 12 months

Secondary Outcomes (3)

Change in mean plasma Aβ42/40 ratio
Up to 12 months
Mean cognition score
Up to 12 months
Mean study partner-reported cognition score
Up to 12 months

Study Arms (3)

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).

Genetic: Blood-based assayDiagnostic Test: Cognitive assessmentsOther: 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.

Genetic: Blood-based assayDiagnostic Test: Cognitive assessmentsOther: Quality of Life Surveys

Partners of Participants

Study partner participants will also be recruited

Other: Quality of Life Surveys

Interventions

Blood-based assayGenetic

Blood samples will be collected

Participants in remission, No ADT (Prostate cancer Control (PC) Cohort))Participants with prostate cancer, ADT (ADT Cohort)

Cognitive assessmentsDiagnostic test

Cognitive assessments will be both participant- and partner-reported

Eligibility Criteria

Age18 Years+

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

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.

You may qualify if:

Patient Participants-

Sponsors & Collaborators

University of California, San Francisco
Otherlead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Biospecimen

Retention: SAMPLES WITH DNA

Blood specimens will be collected

MeSH Terms

Conditions

Prostatic NeoplasmsCognitive Dysfunction

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

Daniel Kwon, MD
University of California, San Francisco
PRINCIPAL INVESTIGATOR

Enrollment

32 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 7, 2023

First Posted

April 20, 2023

Study Start

May 22, 2023

Actual (reported)

Study Stopped

Predicting Cognitive Decline From Androgen Deprivation Therapy

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (3)

Study Arms (3)

Participants with prostate cancer, ADT (ADT Cohort)

Participants in remission, No ADT (Prostate cancer Control (PC) Cohort))

Partners of Participants

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (3)

Study Arms (3)

Participants with prostate cancer, ADT (ADT Cohort)

Participants in remission, No ADT (Prostate cancer Control (PC) Cohort))

Partners of Participants

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations