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RecruitingInterventional

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

NCT ID: NCT06824818Sponsor: University of ChicagoLast updated: 2025-10-01

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.

Arms & interventions

  • BehavioralLHRH 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.

Outcome measures

Primary

  • feasibility of stopping LHRH agonist therapy

    Fraction of patients maintaining castrate testosterone levels

    Time frame: 12 months after discontinuing LHRH agonist therapy

Secondary

  • 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)

Eligibility criteria

Sex: MaleAge: 70 Years and olderHealthy volunteers: No
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 locations (2)

The University of Illinois at Chicago (UIC)

Chicago, Illinois, 60607

Recruiting
TBD TBD · Contact
Natalie Reizine, MD · Principal Investigator

UChicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60637

Not Yet Recruiting
Cancer Clinical Trial Intake · Contact
Nabiel Mir, MD · Principal Investigator