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

University of Chicago155 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

155

Conditions

Elderly Prostate Cancer

Interventions

LHRH Agonist Therapy DiscontinuationBEHAVIORAL

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.

Eligibility

Sex: MALEMin age: 70 Years

Medical Language ↔ Plain English

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

Locations (2)

The University of Illinois at Chicago (UIC)

Chicago, Illinois, United States

RECRUITING

UChicago Medicine Comprehensive Cancer Center

Chicago, Illinois, United States

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

feasibility of stopping LHRH agonist therapy

Fraction of patients maintaining castrate testosterone levels

Time frame: 12 months after discontinuing LHRH agonist therapy

Secondary Outcomes

Patient interest in stopping treatment

Percentage of patients that decline participation in the study

Time frame: End of enrollment (approximately 3 years after study start)

Medication Impact

Percentage of participants that start other prostate cancer treatments before starting or during the study

Time frame: End of study (approximately 3 years after last participant is enrolled)

Impact on Testosterone Levels (12 months)

Percentage of participants with testosterone levels \<20 ng/ml

Time frame: 12 months after last participant starts study

Impact on Testosterone Levels (36 months)

Percentage of participants with testosterone levels \<20 ng/ml

Time frame: 36 months after last participant starts study

Health Care Savings

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)

Time frame: End of study (approximately 3 years after last participant is enrolled)

Visit Compliance

Percentage of missed visits during study compared to number of routine visits missed in 12 month period prior to starting study

Time frame: End of study (approximately 3 years after last participant is enrolled)

Central Contacts

Clinical Trials Intake

CONTACT

1-855-702-8222 cancerclinicaltrials@bsd.uchicago.edu

Data from ClinicalTrials.gov

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