Prostate Cancer Clinical Trial
The Impact of Androgen Ablation Therapy on Cognitive Functioning and Functional Status in Men With Prostate Cancer Age 65 and Older
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.
Full 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.
Eligibility Criteria
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
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There are 2 Locations for this study
Duarte California, 91010, United States
New York New York, 10065, United States
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