The Impact of Androgen Ablation Therapy on Cognitive Functioning and Functional Status in Men With Prostate Cancer Age 65 and Older

NCT00579072 | Active Not Recruiting

• 1 other identifier: 06-084
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to find out if therapy with hormones (such as Lupron, Casodex, Zolodex or Degarelix) change a person's thinking abilities.

Conditions

Prostate Cancer

Keywords

Prostate; cognitive effects; 06-084

Outcome Measures

Primary Outcomes (1)

• Describe changes in cognitive functioning over 6 mos in 70 men with prostate cancer who are about to start androgen ablation therapy vs 70 men with prostate cancer with NED & no medical indication to start Comparison androgen ablation therapy

  3 years

Secondary Outcomes (4)

• Describe differences in cognitive functioning in 80 men with prostate cancer who received Comparison androgen ablation therapy for 6 months - 3 years vs.140 men with prostate cancer who are hormone naïve.

  3 years

• To describe the differences in cognitive functioning in 70 men with prostate cancer who have received androgen ablation therapy for 6 months vs. 80 men with prostate cancer who have received Comparison androgen ablation therapy for 6 months-3 years.

  3 years

• To investigate regionally specific differences in brain activity mediated by testosterone.

  3 years

• To investigate differences in neuropsychological performance on the mental rotation task and their relation to regional brain recruitment as demonstrated in the above outcome

  3 years

Study Arms (2)

Longitudinal Study

Take part in this study because subject has prostate cancer and are over 64 years old. To run this study,need men from two groups. First, we need men who are about to start hormone treatment. Second, we need men who do not plan to use this treatment in the future. We will use this second group as a control group and compare this group to the men who are using this treatment.

Behavioral: Questionaires; Device: fMRI scan (optional)

Group Comparison

Take part in this study because subject has prostate cancer and are over 64 years old. Also, because subject has been on hormone therapy for about two to three years.

Behavioral: Questionaires; Device: fMRI scan (optional)

Interventions

Questionaires BEHAVIORAL

We will use a 6-month longitudinal design to assess the short-term cognitive effects of androgen ablation therapy. We will collect 6-month longitudinal data on 170 men with prostate cancer. All 170 men will be hormone naïve at the start of this study (Hormone Naïve Group). These 170 men will consist of two subgroups. The first subgroup will comprise 70 men with prostate cancer age 65 and older scheduled to start androgen ablation therapy. Their cognitive functioning will be assessed prior to starting androgen ablation therapy or within 21 days after initiation, (i.e. baseline) and then 6 months later (Androgen Ablation Subgroup).The second subgroup will serve as a control group, and consist of 100 men with prostate cancer age 65 and older who are at least 1-year post definitive localized treatment with no evidence of disease and no plan to start androgen ablation therapy (No Androgen Ablation Subgroup).

Longitudinal Study

fMRI scan (optional) DEVICE

Main study participants will be offered to complete an optional fMRI. Fifteen participants from the No Androgen Ablation Subgroup and 15 participants from the Comparison Androgen Ablation Subgroup or Longitudinal Androgen Ablation Subgroup will be recruited for this portion of the study. The fMRI will be scheduled either the same day as the neurocognitive assessment or within eight weeks of the neurocognitive testing. The fMRI will be performed only once at baseline for the Comparison Androgen Ablation Subgroup. The fMRI will be performed at the follow-up time point for the Longitudinal Androgen Ablation Subgroup. The fMRI will be performed at baseline for the No Androgen Ablation Subgroup; if the fMRI can not be completed at baseline (due to participant schedule conflict, lack of fMRI availability, staff schedule conflict, etc.), then the scan will be conducted at the follow-up time point if possible.

Group Comparison; Longitudinal Study

Eligibility Criteria

• Age: 65 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Prostate Cancer Patients

You may qualify if:

• Comparison Androgen Ablation Group
• Diagnosis of prostate cancer
• Age 65 or older
• Ability to converse, write and read English
• In the investigator's judgment, participants must have satisfactory cognitive function to provide valid informed consent and participate in the neurocognitive testing. The Blessed Orientation-Memory-Concentration test (BOMC) will be used as a cognitive screening tool. Patients must have a BOMC score of less than or equal to 11.
• Able to provide informed consent
• Have been on continuous androgen ablation therapy for 6 months to-3 years
• Longitudinal Androgen Ablation Subgroup
• Diagnosis of prostate cancer
• Age 65 or older
• Ability to converse, write and read English
• Able to provide informed consent
• In the investigator's judgment, participants must have satisfactory cognitive function to provide valid informed consent and participate in the neurocognitive testing. The Blessed Orientation-Memory-Concentration test (BOMC) will be used as a cognitive screening tool. Patients must have a BOMC score of less than or equal to 11.
• Starting androgen ablation therapy or started within the past 21 days
• No androgen ablation therapy within the past year

You may not qualify if:

• All Groups
• Previous or current treatment with chemotherapy
• As per medical record or self-report, a history of central nervous system stroke, history of traumatic brain injury, or diagnosis of neurogenerative disorder that affects cognitive function (e.g. Alzheimer's, Parkinson's, Multiple Sclerosis, dementia, seizure disorders, etc.)
• History of untreated psychiatric disease
• As per medical record or self-report, history of loss of consciousness for 60+ minutes and/or admitted to the hospital for a head injury
• Current use of opioids
• History of developmental disorders
• Current or history of alcohol or substance abuse
• Visual, auditory, or other impairment that would preclude ability to complete neuropsychological testing (e.g. significant macular degeneration, being unable to correct hearing with hearing aides, hand tremors, etc.)
• CRITERIA FOR OPTIONAL fMRI
• Patient has a self-reported fear of enclosed spaces (Claustrophobia)
• As per self report or as identified in the medical record, patient has any of the following items that preclude fMRI evaluation:
• Cardiac pacemaker
• Joint replacements
• Aneurysm clips

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• City of Hope National Medical Center: collaborator
• Fordham University: collaborator
• Columbia University: collaborator
• NYU Langone Health: collaborator
• Weill Medical College of Cornell University: collaborator
• Memorial Sloan Kettering Cancer Center: lead

Study Sites (2)

City of Hope

Duarte, California, 91010, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Rebecca Saracino, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 21, 2007
• Study Start: August 1, 2006
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

US (2)