The Impact of Androgen Ablation Therapy on Cognitive Functioning and Functional Status in Men With Prostate Cancer Age 65 and Older
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 230
- 试验地点
- 2
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
- •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
- •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
- •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
排除标准
- •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
- •Insulin pump
- •Wire structures
- •Electrodes
- •Shrapnel/bullets
- •Hearing Aids /implant
- •Implanted electrical devices
- •IUD Metal in eyes
- •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
研究组 & 干预措施
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.
干预措施: Questionaires (Behavioral)
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.
干预措施: fMRI scan (optional) (Device)
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.
干预措施: Questionaires (Behavioral)
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.
干预措施: fMRI scan (optional) (Device)
结局指标
主要结局
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
时间窗: 3 years
次要结局
- 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)
- 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 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)