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


Condition: Prostate Cancer

Intervention:

  • Behavioral: Questionaires
  • Behavioral: Questionaires
  • Device: fMRI scan (optional)

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 Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT00579072

Sponsor: Memorial Sloan Kettering Cancer Center

Primary Outcome Measures:

  • 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
  • Time Frame: 3 years
  • Safety Issue:

Secondary Outcome Measures:

  • 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.
  • Time Frame: 3 years
  • Safety Issue:
  • 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.
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: To investigate regionally specific differences in brain activity mediated by testosterone.
  • Time Frame: 3 years
  • Safety Issue:
  • 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
  • Time Frame: 3 years
  • Safety Issue:

Estimated Enrollment: 280

Study Start Date: August 2006

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Eligibility:

  • Age: minimum 65 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  1. is the same at both sites, and is outlined below: Inclusion Criteria: Comparison Androgen Ablation Group
  2. Diagnosis of prostate cancer
  3. Age 65 or older
  4. Ability to converse, write and read English
  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
  6. Able to provide informed consent
  7. Have been on continuous androgen ablation therapy for 6 months to-3 years Longitudinal Androgen Ablation Subgroup
  8. Diagnosis of prostate cancer
  9. Age 65 or older
  10. Ability to converse, write and read English
  11. Able to provide informed consent
  12. 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
  13. Starting androgen ablation therapy or started within the past 21 days
  14. No androgen ablation therapy within the past year No Androgen Ablation Subgroup
  15. Diagnosis of prostate cancer
  16. Age 65 or older
  17. 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
  18. At least 1-year post definitive localized treatment
  19. Ability to converse, write and read English
  20. Able to provide informed consent
  21. Not anticipated to start androgen ablation therapy Exclusion Criteria: All Groups
  22. Previous or current treatment with chemotherapy
  23. 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.)
  24. History of untreated psychiatric disease
  25. 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
  26. Current use of opioids
  27. History of developmental disorders
  28. Current or history of alcohol or substance abuse
  29. 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:

  • 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

Contact:

  • Christian Nelson, PhD
  • 646-888-0030

Locations:

  • City of Hope
  • Duarte California 91010 United States
  • Memorial Sloan-Kettering Cancer Center
  • New York New York 10021 United States

View trial on ClinicalTrials.gov