Clinical trial · Observational
The Impact of Androgen Ablation Therapy on Cognitive Functioning and Functional Status in Men With Prostate Cancer Age 65 and Older
NCT00579072CI-TRIAL-00110652active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fMRI scan (optional) | Device | — | UNRESOLVED |
| Questionaires | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Longitudinal Study
- description
- 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.
- interventionNames
- Behavioral: Questionaires
- Device: fMRI scan (optional)
- label
- Group Comparison
- description
- 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.
- interventionNames
- Behavioral: Questionaires
- Device: fMRI scan (optional)
Primary outcomes (1)
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.