Prostate cancer hormone therapy may cloud thinking in seniors
NCT ID NCT00579072
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether hormone therapy (like Lupron or Casodex) changes thinking abilities in men aged 65 and older with prostate cancer. Researchers will compare cognitive function over time between men starting hormone therapy, those who have never had it, and those who have been on it for months to years. The goal is to understand potential side effects on memory and thinking, not to treat the cancer itself.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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230 people
The number who actually took part.
- Start date
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Aug 2006
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Prostate Cancer Patients
- Ages
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65 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 Longitudinal 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 8. No history of 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.) 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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City of Hope
Duarte, California, 91010, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a One-Week radiation course match four weeks for prostate cancer?
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- Can a gel cushion shield the rectum during prostate radiation?
- A scanner in the operating room could show surgeons exactly where prostate cancer remains