Clinical trial NCT00579072: The Impact of Androgen Ablation Therapy on Cognitive Functioning and Functional Status in Men With Prostate Cancer Age 65 and Older
Official title: The Impact of Androgen Ablation Therapy on Cognitive Functioning and Functional Status in Men With Prostate Cancer Age 65 and Older
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Prostate Cancer
Keywords: Prostate
cognitive effects
06-084
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: City of Hope National Medical Center
name: Fordham University
name: Columbia University
name: NYU Langone Health
name: Weill Medical College of Cornell University
First posted: 2007-12-21
Enrollment: 230
Sex: MALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prostate Cancer Patients

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.

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.

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

Inclusion Criteria:

Comparison Androgen Ablation Group

1. Diagnosis of prostate cancer
2. Age 65 or older
3. Ability to converse, write and read English
4. 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.
5. Able to provide informed consent
6. Have been on continuous androgen ablation therapy for 6 months to-3 years

Longitudinal Androgen Ablation Subgroup

1. Diagnosis of prostate cancer
2. Age 65 or older
3. Ability to converse, write and read English
4. Able to provide informed consent
5. 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.
6. Starting androgen ablation therapy or started within the past 21 days
7. No androgen ablation therapy within the past year

No Androgen Ablation Subgroup

1. Diagnosis of prostate cancer
2. Age 65 or older
3. 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.
4. At least 1-year post definitive localized treatment
5. Ability to converse, write and read English
6. Able to provide informed consent
7. Not anticipated to start androgen ablation therapy
8. No history of androgen ablation therapy

Exclusion Criteria:

All Groups

1. Previous or current treatment with chemotherapy
2. 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.)
3. History of untreated psychiatric disease
4. 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
5. Current use of opioids
6. History of developmental disorders
7. Current or history of alcohol or substance abuse
8. 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

Primary outcomes:
measure: 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
timeFrame: 3 years
Secondary outcomes:
measure: 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.
timeFrame: 3 years
measure: 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.
timeFrame: 3 years
measure: To investigate regionally specific differences in brain activity mediated by testosterone.
timeFrame: 3 years
measure: To investigate differences in neuropsychological performance on the mental rotation task and their relation to regional brain recruitment as demonstrated in the above outcome
timeFrame: 3 years
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Christian Nelson, PhD
role: PRINCIPAL_INVESTIGATOR
References: