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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


N/A
65 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

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


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 and Zolodex.

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


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. Able to provide informed consent

5. Have been on continuous androgen ablation therapy for 6 months-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. Starting androgen ablation therapy

6. No androgen ablation therapy within the past year

No Androgen Ablation Subgroup

1. Diagnosis of prostate cancer

2. Age 65 or older

3. At least 1-year post definitive localized treatment

4. Ability to converse, write and read English

5. Able to provide informed consent

6. Not anticipated to start androgen ablation therapy

Exclusion Criteria:

All Groups

1. No history of androgen ablation therapy within past year

2. Previous or current treatment with chemotherapy

3. History of neurological brain damage

4. History of untreated psychiatric disease

5. Previous head traumas

6. Current use of opioids

7. History of developmental disorders

8. Current history of alcohol or substance abuse

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Describe changes in cognitive functioning over 6 mos in 40 men with prostate cancer who are about to start androgen ablation therapy vs 40 men with prostate cancer with NED & no medical indication to start Comparison androgen ablation therapy

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Christian Nelson, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

06-084

NCT ID:

NCT00579072

Start Date:

August 2006

Completion Date:

December 2013

Related Keywords:

  • Prostate Cancer
  • Prostate
  • cognitive effects
  • 06-084
  • Prostatic Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
City of HopeDuarte, California  91010