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

September 29, 2025 updated by: University of Chicago

A Feasibility Trial of LHRH Agonist Discontinuation in Elderly Prostate Cancer Patients

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

155

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Recruiting
        • The University of Illinois at Chicago (UIC)
        • Contact:
          • TBD TBD
        • Principal Investigator:
          • Natalie Reizine, MD
      • Chicago, Illinois, United States, 60637
        • Not yet recruiting
        • UChicago Medicine Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Nabiel Mir, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: discontinuation of LHRH agonist therapy in elderly prostate cancer patients
Behavioral: LHRH Agonist Therapy Discontinuation
The intervention involves **discontinuing LHRH agonist therapy** in elderly prostate cancer patients who have been on long-term androgen deprivation therapy. Participants will be monitored for testosterone recovery and PSA levels over a period of up to 3 years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
feasibility of stopping LHRH agonist therapy
Time Frame: 12 months after discontinuing LHRH agonist therapy
Fraction of patients maintaining castrate testosterone levels
12 months after discontinuing LHRH agonist therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient interest in stopping treatment
Time Frame: End of enrollment (approximately 3 years after study start)
Percentage of patients that decline participation in the study
End of enrollment (approximately 3 years after study start)
Medication Impact
Time Frame: 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
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
Percentage of participants with testosterone levels <20 ng/ml
12 months after last participant starts study
Impact on Testosterone Levels (36 months)
Time Frame: 36 months after last participant starts study
Percentage of participants with testosterone levels <20 ng/ml
36 months after last participant starts study
Health Care Savings
Time Frame: 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)
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)
Percentage of missed visits during study compared to number of routine visits missed in 12 month period prior to starting study
End of study (approximately 3 years after last participant is enrolled)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Investigators

  • Study Chair: Nabiel Mir, MD, University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

January 31, 2025

First Submitted That Met QC Criteria

February 12, 2025

First Posted (Actual)

February 13, 2025

Study Record Updates

Last Update Posted (Estimated)

October 1, 2025

Last Update Submitted That Met QC Criteria

September 29, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB24-1729

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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