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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT00579072

Collaborator

National Cancer Institute (NCI) (NIH), City of Hope National Medical Center (Other), Fordham University (Other), Columbia University (Other), NYU Langone Health (Other), Weill Medical College of Cornell University (Other)

230

Enrollment

Locations

208

Duration (Months)

115

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Behavioral: Questionaires Behavioral: Questionaires Device: fMRI scan (optional)

Detailed Description

To find out if this treatment changes things like memory, learning, or concentration. This study is being done to learn more about the effects of this treatment and to help men in the future who use the hormones Lupron, Casodex, Zolodex or Degarelix.

If you choose to take part, you will be asked to do the following:

Fill out questionnaires that ask about:

Your age, eduction, race, and income
Depression
Stress
Energy level
Pain
Memory
Ability to perform daily tasks such as eating, dressing, and taking a shower

Research staff will evaluate you on the following:

Memory
How you prefer to learn new information
Copying designs such as rectangles, squares, and circles
How quickly you think
Your attention span
How well you plan and organize shapes and colors into specific categories

As such, at MSKCC will be contacting a portion of prospective subjects via mail or email to offer them the opportunity to plan for and allocate the necessary time in their personal schedules, should they be interested in the study.

Study Design

Study Type:

Observational

Actual Enrollment :

230 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Aug 1, 2006

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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 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). Device: fMRI scan (optional) 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 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 To supplement the pilot data collected in Aim 1, Aim 2 we will utilize a group comparison design to assess the long-term cognitive effects of androgen ablation therapy. We will collect data on the cognitive functioning of 110 men with prostate cancer age 65 and older who have been on continuous androgen ablation therapy for 1-3 years (2-Year Androgen Ablation Group). These men will complete the study battery once (i.e., the neuropsychological battery, psychosocial questionnaires, and a functional status battery). We will compare the cognitive functioning of these 110 men in the 2-Year Androgen Ablation Group to the 170 men with prostate cancer who are hormone naïve (Hormone Naïve Group). Device: fMRI scan (optional) 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.

Arm

Intervention/Treatment

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

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).

Device: fMRI scan (optional)

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

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

To supplement the pilot data collected in Aim 1, Aim 2 we will utilize a group comparison design to assess the long-term cognitive effects of androgen ablation therapy. We will collect data on the cognitive functioning of 110 men with prostate cancer age 65 and older who have been on continuous androgen ablation therapy for 1-3 years (2-Year Androgen Ablation Group). These men will complete the study battery once (i.e., the neuropsychological battery, psychosocial questionnaires, and a functional status battery). We will compare the cognitive functioning of these 110 men in the 2-Year Androgen Ablation Group to the 170 men with prostate cancer who are hormone naïve (Hormone Naïve Group).

Device: fMRI scan (optional)

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria is the same at both sites, and is outlined below:

Inclusion Criteria:

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

No Androgen Ablation Subgroup

Diagnosis of prostate cancer
Age 65 or older
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.
At least 1-year post definitive localized treatment
Ability to converse, write and read English
Able to provide informed consent
Not anticipated to start androgen ablation therapy
No history of androgen ablation therapy

Exclusion Criteria:

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

Exclusion Criteria:

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
Transdermal patched
Aortic clips
Prosthesis
Intracranial bypass clips
Harrington rod
Coronary Artery bypass clips
Biostimulator
Renal Transplant Clips
Bone or joint pins
Other vascular clips or filters
Tissue expander
Implanted neurostimulators
Metal mesh
Artificial heart valve
Stents
Insulin pump
Wire structures
Electrodes
Shrapnel/bullets
Hearing Aids /implant
Implanted electrical devices
IUD Metal in eyes
Shunts
Ocular Implants
Hair extensions
Hair implants
Tattoos above the waist
Any possible metal in body
As per self report, patient has dentures, body jewelry or wig that they are unable to remove

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	City of Hope	Duarte	California	United States	91010
2	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021

Sponsors and Collaborators

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

Investigators

Principal Investigator: Christian Nelson, PhD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center

Publications

None provided.

Responsible Party:

Memorial Sloan Kettering Cancer Center

ClinicalTrials.gov Identifier:

NCT00579072

Other Study ID Numbers:

06-084

First Posted:

Dec 21, 2007

Last Update Posted:

Mar 21, 2022

Last Verified:

Mar 1, 2022

Keywords provided by Memorial Sloan Kettering Cancer Center

Prostate

cognitive effects

06-084

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of Mar 21, 2022