Recruiting

LHRH Agonist Therapy

Sponsor:

University of Chicago

Code:

NCT06824818

Conditions

Elderly

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 70+

Healthy Volunteers: Not accepted

Interventions

LHRH Agonist Therapy Discontinuation

Study Details

Brief 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.

Conditions

Elderly

Prostate Cancer

Study ID

NCT06824818

Start date

Jun, 2026

Status verified date

Sep, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

155 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: discontinuation of LHRH agonist therapy in elderly prostate cancer patients

Interventions

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 measure

  • feasibility of stopping LHRH agonist therapy [ Time Frame: 12 months after discontinuing LHRH agonist therapy ]

Central Contacts and Locations

Central contacts

Locations

The University of Illinois at Chicago (UIC)

Recruiting

Chicago, Illinois, United States, 60607

Principal Investigator:

Natalie Reizine, MD

More Information

Sponsor

University of Chicago

Last update posted

Oct 1, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2025-10-01.