Hormonal Therapy for Post-Surgery Prostate Cancer Recurrence

Recruiting at 2 trial locations

Overseen By Rodney Breau, Dr.

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: Ottawa Hospital Research Institute

Must be taking: Androgen deprivation therapy

Disqualifiers: Lymph node metastases, others

Stay on Your Current Meds You can continue your current medications while participating

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 12 months

72 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing whether using treatment right after surgery can help prevent prostate cancer from coming back in men who are at high risk. The treatment works by lowering or blocking male hormones that help cancer cells grow. Treatment has been used to block male hormones required for cancer growth, and early treatment has shown to delay worsening in prostate cancer patients with intermediate or poor outlook.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Lupron Depot (leuprolide acetate) for treating prostate cancer recurrence after surgery?

Research shows that leuprolide acetate, a key component of Lupron Depot, is effective in treating advanced prostate cancer. In studies, it helped reduce prostate-specific antigens (markers of cancer activity) and suppressed testosterone levels, which can slow cancer growth. ^{1 2 3 4 5}

Is hormonal therapy for post-surgery prostate cancer recurrence safe?

Leuprolide acetate, known by names like Lupron Depot, Eligard, and Viadur, has been studied for safety in patients with advanced prostate cancer. Research shows it is generally safe and well tolerated, with formulations providing consistent drug delivery and long-term treatment options. ^{1 2 3 6 7}

How does the drug used in hormonal therapy for post-surgery prostate cancer recurrence differ from other treatments?

The drug used in this hormonal therapy is a long-acting leuprolide acetate implant, which provides a continuous release of medication over 12 months, ensuring consistent testosterone suppression without the need for frequent dosing. This makes it unique compared to other treatments that may require more frequent administration and helps improve patient compliance. ^{1 5 7 8 9}

Eligibility Criteria

Men who've had prostate cancer surgery and are at high risk of the cancer coming back can join this trial. They must have a very low PSA level after surgery and a prediction tool must show they're likely to have their cancer return within 5 years.

Inclusion Criteria

My risk of prostate cancer returning within 5 years after surgery is 25% or higher.

My PSA levels were undetectable after surgery.

Exclusion Criteria

I am allergic to some forms of hormone therapy for cancer.

I do not want to receive hormone therapy for cancer.

I have previously undergone androgen deprivation therapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive adjuvant androgen deprivation therapy (ADT) with Lupron Depot injections every 3 months for 12 months

12 months

4 visits (in-person for injections)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• Lupron Depot

Trial Overview The study is testing if giving hormonal therapy (Lupron Depot) for one year after prostate surgery can prevent the cancer from coming back. This approach is compared with usual care in men who are at high risk of recurrence.

Participant Groups

Group I: Standard of Care plus Androgen Deprivation Therapy (Lupron Depot) Experimental Treatment 1 Intervention

22.5 mg intra-muscular injection of Lupron Depot every 3 months for 12 months (4 injections total)

Group II: Standard of Care Active Control 1 Intervention

Standard of Care

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

Tolmar Pharmaceuticals

Collaborator

Trials

1

Recruited

180+

Findings from Research

In a study involving 1,906 patients with advanced prostate cancer, both 3-month and 6-month leuprorelin acetate depot formulations significantly reduced prostate-specific antigen (PSA) levels from an average of 12.0 ng/mL to 0.5 ng/mL after 12 months, indicating effective treatment.

The treatment was well-tolerated, with only 8.8% of patients experiencing adverse events, suggesting that leuprorelin acetate is a safe option for managing advanced prostate cancer in routine clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Tolerability of Leuprorelin Acetate (Eligard®) in Daily Practice in Germany: Pooled Data from 2 Prospective, Non-Interventional Studies with 3- or 6-Month Depot Formulations in Patients with Advanced Prostate Cancer. Ohlmann, CH., Gross-Langenhoff, M.[2018]

The Viadur++ leuprolide delivery system effectively suppressed testosterone levels to the castrate range in 100% of patients over a 12-month period, demonstrating its efficacy in treating advanced prostate cancer.

The treatment was well tolerated, with no serious adverse events linked to the implant, indicating a favorable safety profile for patients receiving this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of an implantable leuprolide delivery system in patients with advanced prostate cancer. Fowler, JE., Gottesman, JE., Reid, CF., et al.[2019]

In a 6-month study involving 117 patients with prostate cancer, the 3-month subcutaneous depot of leuprolide acetate (LA-2550) effectively suppressed serum testosterone levels to below 50 ng/dl in 98% of patients by day 28, and all patients achieved this level by day 35.

The treatment was well-tolerated, with no flare reactions and minimal adverse effects, primarily mild to moderate hot flashes, indicating a favorable safety profile while achieving significant reductions in testosterone and prostate-specific antigen levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinical study of 22.5 mg. La-2550: A new subcutaneous depot delivery system for leuprolide acetate for the treatment of prostate cancer. Chu, FM., Jayson, M., Dineen, MK., et al.[2023]

In a study of 90 patients with prostate cancer, a new 4-month subcutaneous depot of leuprolide acetate effectively reduced serum testosterone levels to below the medical castrate level in 98% of participants by the end of the 8-month study.

The treatment was generally safe, with the most common side effect being mild hot flashes, and no significant flare reactions were reported, indicating a favorable safety profile for this new formulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An eight-month clinical study of LA-2575 30.0 mg: a new 4-month, subcutaneous delivery system for leuprolide acetate in the treatment of prostate cancer. Sartor, O., Dineen, MK., Perez-Marreno, R., et al.[2022]

In a study of 40 patients with stages A2 to C prostatic cancer, leuprorelin acetate depot treatment resulted in 72% of patients showing major responses and 84% achieving normal prostate-specific antigen levels after 2 months.

The treatment effectively suppressed testosterone to castration levels, and while there were three deaths related to the disease, the protocol was well tolerated and showed effectiveness in managing advanced prostatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical experience with leuprorelin acetate before radiotherapy for prostatic cancer. Bourdin, S., Karam, G., Clemain, P., et al.[2017]

The new formulation of leuprorelin acetate (Eligard) effectively suppresses testosterone levels in 98% of patients to levels comparable to surgical orchidectomy, achieving levels as low as 20 ng/dL.

This formulation offers a sustained release system that minimizes breakthrough testosterone levels and has a safety profile similar to other LHRH agonists, with mild side effects like hot flushes being the most common.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a new leuprorelin formulation on testosterone levels in patients with advanced prostate cancer. Berges, R., Bello, U.[2013]

Viadur, a leuprolide acetate implant, effectively lowers serum testosterone levels in advanced prostate cancer patients over a sustained 12-month period, providing long-term palliative hormonal therapy.

The implant is designed for maintenance-free use, enhancing patient compliance and allowing healthcare professionals to focus on other important aspects of patient care, while being generally safe and well tolerated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing advanced prostate cancer with Viadur (leuprolide acetate implant). Moul, JW., Civitelli, K.[2013]

In a clinical trial involving 18 patients with metastatic prostate cancer, the subcutaneous administration of 3.75 mg leuprorelin acetate every 4 weeks effectively suppressed testosterone levels to castration levels, indicating its efficacy in hormone therapy.

The treatment resulted in a low incidence of disease progression and partial responses in five patients, with no side effects reported during the initial flare-up period, suggesting that leuprorelin acetate is a safe option for managing this type of cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary clinical evaluation of leuprorelin acetate depot injection in France, in the management of prostatic cancer. Navratil, H.[2017]

Hormone therapy, particularly with long-acting synthetic LHRH agonists like leuprorelin, is a key treatment for metastatic and locally advanced prostate cancer, providing an alternative to surgical castration.

The 6-month formulation of leuprorelin offers significant advantages over shorter-acting options, potentially establishing it as the standard of care for patients undergoing androgen deprivation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leuprorelin depot injection: patient considerations in the management of prostatic cancer. Abouelfadel, Z., Crawford, ED.[2021]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy and Tolerability of Leuprorelin Acetate (Eligard®) in Daily Practice in Germany: Pooled Data from 2 Prospective, Non-Interventional Studies with 3- or 6-Month Depot Formulations in Patients with Advanced Prostate Cancer. [2018]

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

Safety and efficacy of an implantable leuprolide delivery system in patients with advanced prostate cancer. [2019]

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

A clinical study of 22.5 mg. La-2550: A new subcutaneous depot delivery system for leuprolide acetate for the treatment of prostate cancer. [2023]

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

An eight-month clinical study of LA-2575 30.0 mg: a new 4-month, subcutaneous delivery system for leuprolide acetate in the treatment of prostate cancer. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Clinical experience with leuprorelin acetate before radiotherapy for prostatic cancer. [2017]

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

Effect of a new leuprorelin formulation on testosterone levels in patients with advanced prostate cancer. [2013]

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

Managing advanced prostate cancer with Viadur (leuprolide acetate implant). [2013]

8. England pubmed.ncbi.nlm.nih.gov

Preliminary clinical evaluation of leuprorelin acetate depot injection in France, in the management of prostatic cancer. [2017]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Leuprorelin depot injection: patient considerations in the management of prostatic cancer. [2021]