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NCT Number: NCT06824818

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

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Key information

Conditions

Elderly Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Cancer Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

70 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LHRH Agonist Therapy Discontinuation

Behavioral

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.

Primary outcomes

  1. feasibility of stopping LHRH agonist therapy

    Time frame: 12 months after discontinuing LHRH agonist therapy

    Fraction of patients maintaining castrate testosterone levels

Secondary outcomes

  1. 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

  2. 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

  3. Impact on Testosterone Levels (12 months)

    Time frame: 12 months after last participant starts study

    Percentage of participants with testosterone levels <20 ng/ml

  4. Impact on Testosterone Levels (36 months)

    Time frame: 36 months after last participant starts study

    Percentage of participants with testosterone levels <20 ng/ml

  5. 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)

  6. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Intake

CONTACT

[email protected]

1-855-702-8222

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 13, 2025
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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