Active — Not RecruitingNot Applicable

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

United States230 participantsStarted 2006-08

Plain-language summary

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.

Who can participate

Age range65 Years

SexMALE

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Inclusion criteria

✓. 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 11.
✓. Able to provide informed consent
✓. Have been on continuous androgen ablation therapy for 6 months to-3 years
✓. Diagnosis of prostate cancer
✓. Age 65 or older

Exclusion criteria

✕. 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.)

What they're measuring

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

Timeframe: 3 years

Trial details

NCT IDNCT00579072

SponsorMemorial Sloan Kettering Cancer Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-12

View on ClinicalTrials.gov More Prostate Cancer trials