Stopping prostate cancer hormone injections early in older men
A Feasibility Trial of LHRH Agonist Discontinuation in Elderly Prostate Cancer Patients
This trial tests whether men aged 70 and older who have been on LHRH agonists for more than three years can safely stop the injections while being monitored with regular testosterone testing.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 155 (estimated) |
| Ages | 70 Years and up |
| Sex | Male |
| Sponsor | University of Chicago Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Chicago, Illinois and 1 other locations) |
| Trial ID | NCT06824818 on ClinicalTrials.gov |
What this trial studies
Men 70 years or older who have received continuous LHRH agonist therapy for over three years and have a baseline testosterone below 20 ng/ml will discontinue their LHRH injections and be followed with scheduled testosterone measurements and clinical checks. Eligible participants must have an ECOG performance status of 0–2 and generally no prior chemotherapy or Lu-PSMA unless life expectancy and clinical context are favorable. The study team hypothesizes that long-term androgen ablation may produce permanent castration in some elderly men, making ongoing injections unnecessary. The trial is conducted at University of Chicago Medicine and the University of Illinois at Chicago with close monitoring for testosterone recovery and clinical signs of cancer activity.
Who should consider this trial
Good fit: Ideal participants are men aged 70 or older with prostate cancer who have been on continuous LHRH agonist therapy for more than three years, have a baseline testosterone under 20 ng/ml, and have ECOG performance status 0–2.
Not a fit: Patients with rising PSA or other evidence of active disease, detectable or recovering testosterone levels, recent chemotherapy or Lu-PSMA without favorable prognosis, those younger than 70, or those with less than three years of LHRH therapy are less likely to benefit from stopping treatment.
Why it matters
Potential benefit: If successful, older patients could avoid ongoing hormone injections, reducing side effects, clinic visits, and costs while maintaining cancer control.
How similar studies have performed: Intermittent androgen-deprivation strategies have shown feasibility in other contexts, but permanently stopping long-term LHRH therapy specifically in elderly patients is relatively novel and not widely proven.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chicago, Illinois and 1 other locations
- The University of Illinois at Chicago (UIC) — Chicago, Illinois, United States (Recruiting)
- UChicago Medicine Comprehensive Cancer Center — Chicago, Illinois, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: Clinical Trials Intake
- Email: cancerclinicaltrials@bsd.uchicago.edu
- Phone: 1-855-702-8222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.