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Discontinuation of Standard LHRH Agonist Therapy in Elderly Prostate Cancer Patients
Trial Status: active
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.
Inclusion Criteria
Patients must have histologically or cytologically confirmed prostate cancer with ongoing androgen deprivation therapy for > 3 years with any LHRH agonist
Age ≥ 70 years
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
Baseline testosterone of < 20 ng/ml
Patients must not have prior chemotherapy or Lu-PSMA OR
* For patients with ongoing or prior taxane-based therapy a Halabi nomogram predicted 18-month (mon) survival > 50% OR
* For patients with ongoing or planned Lu-PSMA based therapy a University of California Los Angeles (UCLA) nomogram predicted 18-month survival > 50%
Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria
Patients with cognitive impairment or medical conditions that limit decision-making capacity, preventing them from providing informed consent. This includes individuals with moderate to severe dementia, delirium, or other neurological conditions affecting comprehension and decision-making
Cognitive impairment precluding informed consent
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06824818.
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:
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
