This clinical trial tests whether it is possible for elderly prostate cancer patients to stop their standard luteinizing hormone-releasing hormone (LHRH) agonist therapy and still maintain very low testosterone levels. As a standard part of LHRH agonist therapy, men with prostate cancer typically receive life-long injections to lower their testosterone levels, which may slow or stop the growth or spread of prostate tumor cells that need testosterone to grow. However, life-long injections pose a significant financial and logistical burden, especially for elderly patients. A return to normal testosterone levels after stopping LHRH agonist therapy is often prolonged and incomplete, meaning it may be feasible for elderly prostate cancer patients to stop LHRH agonist therapy without their testosterone levels rising.
Additional locations may be listed on ClinicalTrials.gov for NCT06824818.
Locations matching your search criteria
United States
Illinois
Chicago
University of Chicago Comprehensive Cancer CenterStatus: Active
Contact: Nabiel Ali Mir
Phone: 773-702-7609
PRIMARY OBJECTIVE:
I. To assess the feasibility of discontinuing LHRH agonist therapy in elderly advanced prostate cancer patients as determined by the fraction of patients with castrate levels of testosterone (< 50 ng/ml) (or testosterone > 20 with rising prostate specific antigen [PSA]) at 12 months.
SECONDARY OBJECTIVES:
I. To assess the broader clinical impact of LHRH agonist discontinuation in elderly advanced prostate cancer patients as assessed by:
Ia. Fraction of patients declining trial participation;
Ib. Fraction of patients meeting primary endpoint based on additional therapies at enrollment or during study:
Ibi. 2nd generation androgen synthesis inhibitors (e.g. abiraterone);
Ibii. 2nd generation androgen receptor inhibitors;
Ibiii. Taxane therapy;
Ibiv. Lutetium-prostate specific membrane antigen (Lu-PSMA) based therapy;
Ic. Fraction of patients with testosterone levels < 20 ng/ml at 12 months;
Id. Fraction of patients with testosterone levels < 20 or < 50 at 3 years;
Ie. LHRH cost savings per patient over the trial duration as calculated from hospital drug charges;
If. Patient visit compliance as assessed by fraction of follow up visits missed during trial in comparison to fraction missed in the 12 months prior to trial enrollment.
OUTLINE:
Patients discontinue standard of care LHRH agonist therapy. Patients also undergo collection of blood samples on study.
After discontinuation of standard therapy, patients are followed up every 3-6 months for up to 3 years.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationUniversity of Chicago Comprehensive Cancer Center
Principal InvestigatorNabiel Ali Mir
