New York, New York 10021


Purpose:

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.


Study summary:

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


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 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 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.) Androgen Ablation Subgroup and No Androgen Ablation Subgroup Only 1) History of androgen ablation therapy within the past year of the date of consent 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


NCT ID:

NCT00579072


Primary Contact:

Principal Investigator
Christian Nelson, PhD
Memorial Sloan Kettering Cancer Center

Christian Nelson, PhD
Phone: 646-888-0030


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States

Christian Nelson, PhD
Phone: 646-888-0030

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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