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

NCT ID: NCT06824818

Last Updated: 2025-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-06-30

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Elderly Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The study follows a \*\*single-group assignment\*\* model, where all participants discontinue LHRH agonist therapy and are monitored for testosterone and PSA levels over 3 years to assess the feasibility of this approach.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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discontinuation of LHRH agonist therapy in elderly prostate cancer patients

Group Type EXPERIMENTAL

LHRH Agonist Therapy Discontinuation

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nabiel Mir, MD

Role: STUDY_CHAIR

University of Chicago

Locations

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The University of Illinois at Chicago (UIC)

Chicago, Illinois, United States

Site Status RECRUITING

UChicago Medicine Comprehensive Cancer Center

Chicago, Illinois, United States

Site Status NOT_YET_RECRUITING

Countries

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United States

Central Contacts

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Clinical Trials Intake

Role: CONTACT

1-855-702-8222

Facility Contacts

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TBD TBD

Role: primary

Cancer Clinical Trial Intake

Role: primary

855-702-8222

Other Identifiers

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IRB24-1729

Identifier Type: -

Identifier Source: org_study_id

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