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Recruiting NCT06824818

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

No phase Interventional Elderly Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LHRH Agonist Therapy Discontinuation.
Who it may be relevant to
Registry conditions: Elderly, Prostate Cancer. Basic parameters: from 70 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • feasibility of stopping LHRH agonist therapy [Time frame: 12 months after discontinuing LHRH agonist therapy]
Secondary outcome measures (6)
  • 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 2 centers
  • The University of Illinois at Chicago (UIC) — Chicago
  • UChicago Medicine Comprehensive Cancer Center — Chicago

Identifiers

NCT: NCT06824818 · IRB24-1729

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗