Study to Assess the Feasibility of Stopping Prostate Cancer Treatment Early in Elderly Patients
Clinicaltrials.gov ID:
NCT06824818
Status
RECRUITING
Phase
NA
Age
≥ 70 Years
Enrollments
155Conditions
Elderly, Prostate CancerSummary
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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- TBD TBD
Study Chair
- Nabiel Mir, MD
Eligibility 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
Outcome Measures
Primary Outcome Measures
feasibility of stopping LHRH agonist therapy
Time Frame: 12 months after discontinuing LHRH agonist therapy
Secondary Outcome Measures
Patient interest in stopping treatment
Time Frame: End of enrollment (approximately 3 years after study start)
Medication Impact
Time Frame: End of study (approximately 3 years after last participant is enrolled)
Impact on Testosterone Levels (12 months)
Time Frame: 12 months after last participant starts study
Impact on Testosterone Levels (36 months)
Time Frame: 36 months after last participant starts study
Health Care Savings
Time Frame: End of study (approximately 3 years after last participant is enrolled)
Visit Compliance
Time Frame: End of study (approximately 3 years after last participant is enrolled)
Timeline
Last Updated
June 10, 2025Start Date
February 13, 2025Today
October 16, 2025Completion Date ( Estimated )
June 1, 2027
Sponsors of this trial
Lead Sponsor
University of Chicago
RECRUITING 
≥ 18 Years