Study to Assess the Feasibility of Stopping Prostate Cancer Treatment Early in Elderly Patients

Not Applicable

Not yet recruiting

• Conditions: Elderly; Prostate Cancer

• Registration Number: NCT06824818
• Lead Sponsor: University of Chicago

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-31
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-12
• Last Update Submitted: 2025-02-12
• Study First Posted: 2025-02-13
• Last Update Posted: 2025-02-13
• Study Start: 2025-06
• Primary Completion: 2026-12
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 155

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
feasibility of stopping LHRH agonist therapy	12 months after discontinuing LHRH agonist therapy	Fraction of patients maintaining castrate testosterone levels

Secondary Outcome Measures

Name	Time	Method
Patient interest in stopping treatment	End of enrollment (approximately 3 years after study start)	Percentage of patients that decline participation in the study
Medication Impact	End of study (approximately 3 years after last participant is enrolled)	Percentage of participants that start other prostate cancer treatments before starting or during the study
Impact on Testosterone Levels (12 months)	12 months after last participant starts study	Percentage of participants with testosterone levels \<20 ng/ml
Impact on Testosterone Levels (36 months)	36 months after last participant starts study	Percentage of participants with testosterone levels \<20 ng/ml
Health Care Savings	End of study (approximately 3 years after last participant is enrolled)	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)
Visit Compliance	End of study (approximately 3 years after last participant is enrolled)	Percentage of missed visits during study compared to number of routine visits missed in 12 month period prior to starting study

Trial Locations

Locations (2)

The University of Illinois at Chicago (UIC); 🇺🇸 Chicago, Illinois, United States

UChicago Medicine Comprehensive Cancer Center; 🇺🇸 Chicago, Illinois, United States