ElderlyNCT06824818
Study to Assess the Feasibility of Stopping Prostate Cancer Treatment Early in Elderly Patients
A study testing LHRH Agonist Therapy Discontinuation in people with Elderly and Prostate Cancer, run by University of Chicago at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 70 years and older, men only
- Conditions the study is for
- Elderly, Prostate Cancer
- What is being tested?
- LHRH Agonist Therapy Discontinuation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- Men only
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- none
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
The University of Illinois at Chicago (UIC)
Chicago, Illinois, 60607
TBD TBD
Natalie Reizine, MD
- Not yet recruiting
UChicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637
Cancer Clinical Trial Intake, 855-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Nabiel Mir, MD
About this study
Official title: A Feasibility Trial of LHRH Agonist Discontinuation in Elderly Prostate Cancer 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.
- Conditions
- Elderly, Prostate Cancer
- Being tested
- LHRH Agonist Therapy Discontinuation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LHRH Agonist Therapy DiscontinuationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| discontinuation of LHRH agonist therapy in elderly prostate cancer patients | Experimental | Not described Receives: Behavioral: LHRH Agonist Therapy Discontinuation |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility of stopping LHRH agonist therapy
Fraction of patients maintaining castrate testosterone levels
Measured: 12 months after discontinuing LHRH agonist therapy
Secondary outcomes (6)
Patient interest in stopping treatment
Percentage of patients that decline participation in the study
Measured: 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
Measured: 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
Measured: 12 months after last participant starts study
Impact on Testosterone Levels (36 months)
Percentage of participants with testosterone levels <20 ng/ml
Measured: 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)
Measured: 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
Measured: End of study (approximately 3 years after last participant is enrolled)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study startJun 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nabiel Mir, MD, Study chair, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06824818
- Sponsor's protocol ID
- IRB24-1729
- Status last verified
- Sep 2025
- First submitted
- 31 Jan 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Trial of LHRH Agonist Discontinuation in Elderly Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT06824818
- Acronym / sponsor ID
- IRB24-1729
- Conditions
- Elderly, Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 13 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| discontinuation of LHRH agonist therapy in elderly prostate cancer patients | Experimental | Behavioral: LHRH Agonist Therapy Discontinuation |
Who may qualify
- Ages
- 70 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LHRH Agonist Therapy DiscontinuationThe 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. | Behavioural | discontinuation of LHRH agonist therapy in elderly prostate cancer patients |
Primary outcome
feasibility of stopping LHRH agonist therapy
Time frame: 12 months after discontinuing LHRH agonist therapy
Fraction of patients maintaining castrate testosterone levels
6 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nabiel Mir, MD study chair
University of Chicago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LHRH Agonist Therapy Discontinuation in people with Elderly and Prostate Cancer, run by University of Chicago at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Intake (1-855-702-8222, cancerclinicaltrials@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
feasibility of stopping LHRH agonist therapy (time frame: 12 months after discontinuing LHRH agonist therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.