Elderly, Prostate Cancer
Conditions
Brief summary
This study seeks to identify if it is feasible to stop Luteinizing Hormone-Releasing Hormone (LHRH) Agonist Therapy in elderly men with prostate cancer. We hypothesize that elderly prostate cancer patients on long term androgen ablation with LHRH agonists will be permanently castrated and do not require ongoing LHRH agonist therapy. Participants will be monitored by testosterone testing throughout study.
Interventions
BEHAVIORALLHRH Agonist Therapy Discontinuation
The intervention involves \*\*discontinuing LHRH agonist therapy\*\* in elderly prostate cancer patients who have been on long-term androgen deprivation therapy. Participants will be monitored for testosterone recovery and PSA levels over a period of up to 3 years.
Sponsors
University of Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study follows a \*\*single-group assignment\*\* model, where all participants discontinue LHRH agonist therapy and are monitored for testosterone and PSA levels over 3 years to assess the feasibility of this approach.
Eligibility
Sex/Gender
MALE
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Prostate cancer with \>3 years of LHRH agonist therapy. * Age ≥70 years. * ECOG performance status ≤2 * Baseline testosterone of \< 20 ng/ml * No prior chemotherapy or Lu-PSMA (unless survival predictions are favorable). * Ability to understand and sign informed consent.
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| feasibility of stopping LHRH agonist therapy | 12 months after discontinuing LHRH agonist therapy | Fraction of patients maintaining castrate testosterone levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medication Impact | End of study (approximately 3 years after last participant is enrolled) | Percentage of participants that start other prostate cancer treatments before starting or during the study |
| Impact on Testosterone Levels (12 months) | 12 months after last participant starts study | Percentage of participants with testosterone levels \<20 ng/ml |
| Patient interest in stopping treatment | End of enrollment (approximately 3 years after study start) | Percentage of patients that decline participation in the study |
| Health Care Savings | End of study (approximately 3 years after last participant is enrolled) | Cost savings per participant measured by cost of the drug (e.g. how much was saved by participants not taking drug during the study period) |
| Visit Compliance | End of study (approximately 3 years after last participant is enrolled) | Percentage of missed visits during study compared to number of routine visits missed in 12 month period prior to starting study |
| Impact on Testosterone Levels (36 months) | 36 months after last participant starts study | Percentage of participants with testosterone levels \<20 ng/ml |
Countries
United States
Contacts
Primary ContactClinical Trials Intake
Outcome results
None listed