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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| discontinuation of LHRH agonist therapy in elderly prostate cancer patients | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LHRH Agonist Therapy Discontinuation | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| feasibility of stopping LHRH agonist therapy | Fraction of patients maintaining castrate testosterone levels | 12 months after discontinuing LHRH agonist therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Patient interest in stopping treatment | Percentage of patients that decline participation in the study | End of enrollment (approximately 3 years after study start) |
| Medication Impact | Percentage of participants that start other prostate cancer treatments before starting or during the study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Intake | Contact | 1-855-702-8222 | cancerclinicaltrials@bsd.uchicago.edu |
| Name | Affiliation | Role |
|---|---|---|
| Nabiel Mir, MD | University of Chicago | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Illinois at Chicago (UIC) | Recruiting | Chicago | Illinois | 60607 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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.
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|
| End of study (approximately 3 years after last participant is enrolled) |
| Impact on Testosterone Levels (12 months) | Percentage of participants with testosterone levels <20 ng/ml | 12 months after last participant starts study |
| Impact on Testosterone Levels (36 months) | Percentage of participants with testosterone levels <20 ng/ml | 36 months after last participant starts study |
| Health Care Savings | 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) | End of study (approximately 3 years after last participant is enrolled) |
| Visit Compliance | Percentage of missed visits during study compared to number of routine visits missed in 12 month period prior to starting study | End of study (approximately 3 years after last participant is enrolled) |
| UChicago Medicine Comprehensive Cancer Center | Not yet recruiting | Chicago | Illinois | 60637 | United States |
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |