LHRH Agonist Therapy Discontinuation for Prostate Cancer

Recruiting at 1 trial location

Overseen By Clinical Trials Intake

Age: 65+

Sex: Male

Trial Phase: Academic

Sponsor: University of Chicago

Must be taking: LHRH agonists

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

155 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial focuses on stopping LHRH agonist therapy for prostate cancer, so you may need to stop this specific medication. The protocol does not specify about other medications, so it's best to discuss with the trial team.

Is LHRH Agonist Therapy generally safe for humans?

LHRH Agonist Therapy is generally considered safe for humans, but it can have side effects like weight gain, heart problems, hot flashes, erectile dysfunction, and bone thinning, which can affect quality of life. In some studies, no toxicity was observed, and the treatment was well tolerated. ^{1 2 3 4 5}

How does LHRH Agonist Therapy differ from other prostate cancer treatments?

LHRH Agonist Therapy is unique because it works by reducing testosterone levels through a process called 'selective medical hypophysectomy', which involves downregulating hormone receptors to suppress testosterone production. This therapy requires strict adherence to a schedule, as delays can lead to disease flare-ups, making patient compliance crucial. ^{6 7 8 9 10}

What data supports the effectiveness of LHRH Agonist Therapy for prostate cancer?

LHRH Agonist Therapy is effective in treating advanced prostate cancer, as it helps lower testosterone levels, which can slow the growth of cancer cells. Studies show that many patients experience partial remission or stable disease, and the treatment is generally well-tolerated. ^{3 8 10 11 12}

Research Team

Nabiel Mir, MD

Principal Investigator

University of Chicago

Eligibility Criteria

This trial is for elderly men with prostate cancer who have been on long-term androgen ablation therapy using LHRH agonists. They should be stable enough to consider stopping treatment, with close monitoring through testosterone testing.

Inclusion Criteria

I have been on LHRH therapy for prostate cancer for over 3 years.

I can do most of my daily activities on my own.

My testosterone level is below 20 ng/ml.

Exclusion Criteria

Not applicable.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Discontinuation

Discontinuation of LHRH agonist therapy in elderly prostate cancer patients

12 months

Regular testosterone testing visits

Follow-up

Participants are monitored for safety and effectiveness after treatment discontinuation

36 months

Periodic visits for testosterone level monitoring

Treatment Details

Interventions

• LHRH Agonist Therapy

Trial Overview The study is testing the feasibility of discontinuing LHRH Agonist Therapy in these patients. The hypothesis is that they may already be permanently castrated due to the long-term therapy and might not need continuous treatment.

Participant Groups

Group I: discontinuation of LHRH agonist therapy in elderly prostate cancer patients Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Findings from Research

In a phase II study involving 62 advanced prostate cancer patients, high-dose estetrol (HDE4) combined with androgen deprivation therapy (ADT) significantly reduced the frequency and severity of hot flushes, with only 13.5% of patients experiencing weekly hot flushes compared to 60% in the placebo group.

HDE4 treatment also led to a more rapid and profound suppression of total and free testosterone, prostate-specific antigen (PSA), and follicle-stimulating hormone (FSH), while showing no serious cardiovascular adverse events, indicating its potential for enhanced disease control and safety in ADT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Estetrol Cotreatment of Androgen Deprivation Therapy in Infiltrating or Metastatic, Castration-sensitive Prostate Cancer: A Randomized, Double-blind, Phase II Trial (PCombi). Coelingh Bennink, HJT., van Moorselaar, JA., Crawford, ED., et al.[2022]

In a study of 68 patients with metastatic prostate cancer, both leuprolide and triptorelin effectively reduced plasma testosterone levels, with leuprolide showing a faster decrease at 1 month.

While both treatments were effective in lowering testosterone, there were no significant differences in clinical efficacy or overall safety between the two LHRH analogues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Tolerance and clinical and biological responses during the first 6 months of treatment with 1-month sustained release LHRH agonists leuprolerin and triptolerin in patients with metastatic prostate cancer]. Abbou, CC., Lucas, C., Leblanc, V.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Individual variation of hormonal recovery after cessation of luteinizing hormone-releasing hormone agonist therapy in men receiving long-term medical castration therapy for prostate cancer. [2013]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Estetrol Cotreatment of Androgen Deprivation Therapy in Infiltrating or Metastatic, Castration-sensitive Prostate Cancer: A Randomized, Double-blind, Phase II Trial (PCombi). [2022]

3. England pubmed.ncbi.nlm.nih.gov

LHRH analogue as a depot preparation (Zoladex) in the treatment of advanced carcinoma of the prostate followed by orchiectomy as a second line therapy--a phase II study. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Evolution of therapeutic approaches with luteinizing hormone-releasing hormone agonists in 2003. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Does oral antiandrogen use before leuteinizing hormone-releasing hormone therapy in patients with metastatic prostate cancer prevent clinical consequences of a testosterone flare? [2013]

6. England pubmed.ncbi.nlm.nih.gov

Luteinising hormone-releasing hormone antagonists in prostate cancer therapy. [2019]

7. France pubmed.ncbi.nlm.nih.gov

[Tolerance and clinical and biological responses during the first 6 months of treatment with 1-month sustained release LHRH agonists leuprolerin and triptolerin in patients with metastatic prostate cancer]. [2018]

8. Germany pubmed.ncbi.nlm.nih.gov

[Prostate Cancer: Side-Effect Management for Androgen Deprivation Therapy]. [2023]

9. India pubmed.ncbi.nlm.nih.gov

Systemic bias in the medical literature on androgen deprivation therapy and its implication to clinical practice. [2017]

10. United States pubmed.ncbi.nlm.nih.gov

Hormonal therapy for patients with advanced adenocarcinoma of the prostate: is there a role for discontinuing treatment after prolonged androgen suppression? [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Traditional approaches to androgen deprivation therapy. [2013]

12. United States pubmed.ncbi.nlm.nih.gov

Patient compliance in treatment of prostate cancer with luteinizing hormone-releasing hormone (LHRH) agonist. [2019]