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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| City of Hope National Medical Center | OTHER |
| Fordham University | OTHER |
| Columbia University |
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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.
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:
Research staff will evaluate you on the following:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionaires | Behavioral | We will use a 6-month longitudinal design to assess the short-term cognitive effects of androgen ablation therapy. We will collect 6-month longitudinal data on 170 men with prostate cancer. All 170 men will be hormone naïve at the start of this study (Hormone Naïve Group). These 170 men will consist of two subgroups. The first subgroup will comprise 70 men with prostate cancer age 65 and older scheduled to start androgen ablation therapy. Their cognitive functioning will be assessed prior to starting androgen ablation therapy or within 21 days after initiation, (i.e. baseline) and then 6 months later (Androgen Ablation Subgroup).The second subgroup will serve as a control group, and consist of 100 men with prostate cancer age 65 and older who are at least 1-year post definitive localized treatment with no evidence of disease and no plan to start androgen ablation therapy (No Androgen Ablation Subgroup). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 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. |
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Inclusion Criteria is the same at both sites, and is outlined below:
Inclusion Criteria:
Comparison Androgen Ablation Group
Longitudinal Androgen Ablation Subgroup
No Androgen Ablation Subgroup
Exclusion Criteria:
All Groups
CRITERIA FOR OPTIONAL fMRI
Exclusion Criteria:
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Prostate Cancer Patients
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Saracino, PhD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States | ||
| Memorial Sloan Kettering Cancer Center |
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| Label | URL |
|---|---|
| Memorial Sloan-Kettering Cancer Center | View source |
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| OTHER |
| NYU Langone Health | OTHER |
| Weill Medical College of Cornell University | OTHER |
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| Questionaires | Behavioral | To supplement the pilot data collected in Aim 1, Aim 2 we will utilize a group comparison design to assess the long-term cognitive effects of androgen ablation therapy. We will collect data on the cognitive functioning of 110 men with prostate cancer age 65 and older who have been on continuous androgen ablation therapy for 1-3 years (2-Year Androgen Ablation Group). These men will complete the study battery once (i.e., the neuropsychological battery, psychosocial questionnaires, and a functional status battery). We will compare the cognitive functioning of these 110 men in the 2-Year Androgen Ablation Group to the 170 men with prostate cancer who are hormone naïve (Hormone Naïve Group). |
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| fMRI scan (optional) | Device | Main study participants will be offered to complete an optional fMRI. Fifteen participants from the No Androgen Ablation Subgroup and 15 participants from the Comparison Androgen Ablation Subgroup or Longitudinal Androgen Ablation Subgroup will be recruited for this portion of the study. The fMRI will be scheduled either the same day as the neurocognitive assessment or within eight weeks of the neurocognitive testing. The fMRI will be performed only once at baseline for the Comparison Androgen Ablation Subgroup. The fMRI will be performed at the follow-up time point for the Longitudinal Androgen Ablation Subgroup. The fMRI will be performed at baseline for the No Androgen Ablation Subgroup; if the fMRI can not be completed at baseline (due to participant schedule conflict, lack of fMRI availability, staff schedule conflict, etc.), then the scan will be conducted at the follow-up time point if possible. |
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| 3 years |
| To investigate regionally specific differences in brain activity mediated by testosterone. | 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 |
| New York |
| New York |
| 10065 |
| United States |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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