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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Memorial Sloan Kettering Cancer Center
Sponsor:
Collaborators:
National Cancer Institute (NCI)
City of Hope National Medical Center
Fordham University
Columbia University
New York University School of Medicine
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00579072
First received: December 19, 2007
Last updated: September 7, 2016
Last verified: September 2016
  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.

Condition Intervention
Prostate Cancer
Behavioral: Questionaires
Device: fMRI scan (optional)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Impact of Androgen Ablation Therapy on Cognitive Functioning and Functional Status in Men With Prostate Cancer Age 65 and Older

Resource links provided by NLM:


Further study details as provided by Memorial Sloan Kettering Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To investigate regionally specific differences in brain activity mediated by testosterone. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: August 2006
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Behavioral: Questionaires
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).
Device: fMRI scan (optional)
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 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.
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.
Behavioral: Questionaires
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).
Device: fMRI scan (optional)
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 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.

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
  Eligibility

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Prostate Cancer Patients
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00579072

Contacts
Contact: Christian Nelson, PhD 646-888-0030

Locations
United States, California
City of Hope Active, not recruiting
Duarte, California, United States, 91010
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Christian Nelson, PhD    646-888-0030      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
City of Hope National Medical Center
Fordham University
Columbia University
New York University School of Medicine
Weill Medical College of Cornell University
Investigators
Principal Investigator: Christian Nelson, PhD Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00579072     History of Changes
Other Study ID Numbers: 06-084 
Study First Received: December 19, 2007
Last Updated: September 7, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan Kettering Cancer Center:
Prostate
cognitive effects
06-084

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Androgens
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 02, 2016