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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if elderly men with prostate cancer can safely discontinue LHRH agonist therapy, a treatment that reduces male hormones. Researchers believe that after long-term use, these patients might no longer need the therapy. Participants will have their testosterone levels checked to assess the feasibility of stopping the treatment. Men aged 70 or older, who have had prostate cancer and been on LHRH therapy for more than three years, are suitable candidates for this study. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance future treatment plans for prostate cancer patients.

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.

What prior data suggests that discontinuing LHRH agonist therapy is safe for elderly prostate cancer patients?

Research has shown that stopping LHRH (Luteinizing Hormone-Releasing Hormone) therapy in prostate cancer patients can be safe. One study found that patients who fully responded to treatment could safely discontinue LHRH medications. This suggests that stopping the therapy might not cause harm for those who have responded well.

LHRH medications, such as goserelin, provide long-term benefits in treating prostate cancer by lowering testosterone levels, which can slow cancer growth. However, if the treatment is no longer necessary, discontinuing it might not be risky, especially with regular check-ups.

Overall, current research indicates that for patients who have responded well, stopping LHRH therapy could be safe. It is important to maintain close contact with healthcare providers during this time. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for prostate cancer, which typically involves the continuous use of LHRH agonist therapy to manage the disease, this approach explores the potential benefits of discontinuing LHRH agonist therapy in elderly patients. Researchers are excited about this because it could lead to fewer side effects and improved quality of life without compromising the effectiveness of the treatment. This trial aims to find out if periodic cessation of therapy can maintain cancer control while reducing exposure to medication, which could be a game-changer for many patients.

What evidence suggests that discontinuing LHRH agonist therapy might be effective for prostate cancer?

This trial will investigate the discontinuation of LHRH agonist therapy in elderly prostate cancer patients. Studies have shown that stopping LHRH agonist therapy after a complete response is possible and safe for these patients. Research indicates that LHRH agonists effectively lower testosterone levels, which can help slow cancer growth. Specifically, one study found that even after stopping the treatment, 53% of men who had been on it for four or more years continued to have low testosterone levels for up to 2.5 years. This finding suggests that the therapy's effects might last, reducing the need for ongoing treatment in some older patients. ^{1 2 3 6 7}

Who Is on the Research Team?

Nabiel Mir, MD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/jco.2005.23.16_suppl.4763

Withdrawal of LHRH therapy in selected prostate cancer ... Conclusions: We concluded that LHRH agonists therapy withdrawal in prostate cancer patients in complete response is possible and safe.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11667785/

Luteinizing hormone-releasing hormone receptor agonists ... LHRH-R agonists and antagonists, particularly goserelin, have demonstrated long-term survival benefits in patients with localized and locally advanced prostate ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0090429507022017

Serum Testosterone Recovery After Cessation of Long ... Of the men who had received 4 or more years of LHRH agonist therapy for prostate cancer, 53% remained castrated up to 2.5 years after therapy cessation.

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa2004325

Oral Relugolix for Androgen-Deprivation Therapy in ... In this trial involving men with advanced prostate cancer, relugolix achieved rapid, sustained suppression of testosterone levels that was superior to that with ...

5. withpower.com withpower.com/trial/phase-prostate-cancer-5-2025-00a00

LHRH Agonist Therapy Discontinuation 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.

6. nature.com nature.com/articles/s41391-022-00533-6

LHRH sparing therapy in patients with chemotherapy-naïve ... Recent results indicated that treatment with abiraterone acetate (AA) plus prednisone (P) further suppresses serum testosterone levels over ADT alone.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2588931125002834

The EORTC GUCG-1414 Phase 3 Randomized Trial Median age was 72 yr. A PSA nadir of <0.1 ng/ml was achieved by 60% of patients in the agonist arm and 52% in the degarelix arm (odds ratio ...