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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding hormonal therapy, specifically androgen deprivation therapy (ADT), immediately after surgery can prevent prostate cancer from returning. Prostate cancer often recurs in men post-surgery, and this study tests if Lupron Depot, a form of hormonal therapy administered every three months for a year, can improve outcomes. Participants will receive either standard care or standard care plus Lupron Depot. Men who have undergone prostate cancer surgery, have a low PSA level (a protein that can indicate cancer), and are at high risk of recurrence might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Lupron Depot, a treatment used in hormone therapy, is generally well-tolerated. In studies, about 38% of patients experienced some side effects. Common issues included reactions at the injection site, hot flashes, and a temporary increase in cancer symptoms known as tumor flare. One study found that Lupron Depot effectively lowered testosterone levels, its main purpose in treating prostate cancer, and patients managed well with it over a year.

However, some risks require consideration. Lupron Depot may increase the chance of heart problems, such as heart attacks or strokes. Discussing these risks with a doctor before starting treatment is important. Overall, past research suggests that while some side effects exist, Lupron Depot is mostly safe for use in prostate cancer care. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for prostate cancer?

Unlike the standard of care for recurring prostate cancer, which typically involves monitoring or radiation, Lupron Depot offers a proactive approach with androgen deprivation therapy. Researchers are excited about Lupron Depot because it works by reducing testosterone levels, which can help slow the growth of prostate cancer cells. This treatment is delivered via an injection every three months, providing a convenient option with fewer frequent doses. By directly targeting hormone levels, Lupron Depot may offer a more effective way to manage cancer recurrence compared to traditional methods that don't involve hormonal intervention.

What evidence suggests that Lupron Depot might be an effective treatment for prostate cancer recurrence?

Research has shown that Lupron Depot, a type of hormone therapy, effectively treats prostate cancer. One study found that 72% of patients with certain stages of prostate cancer responded positively to the treatment. Another study reported that 83% of patients experienced a partial or complete response after using leuprorelin, the main ingredient in Lupron Depot. This trial will compare the standard of care alone with the standard of care plus Androgen Deprivation Therapy using Lupron Depot. This treatment lowers testosterone levels, which can help slow or stop the growth of prostate cancer cells. These findings suggest that Lupron Depot may help prevent prostate cancer from returning after surgery. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

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]

Citations

1. withpower.com withpower.com/trial/phase-3-recurrence-2-2022-8bc9d

Hormonal Therapy for Post-Surgery Prostate Cancer ... 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% ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1477616/

The Effective Management of Biochemical Recurrence in ... Treatment of postoperative or postradiation PSA recurrence involves several modalities, including luteinizing hormone-releasing hormone agonists.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4107255/

Efficacy and tolerability of 1- and 3-month leuprorelin ... Partial or complete treatment response was observed in 83% of patients at the final visit (according to the physician's assessment). Ninety-two patients (37.86 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04423211

NCT04423211 | Treating Prostate Cancer That Has Come ... After completion of study treatment, patients are followed up every 3 months for the first 2 years, every 6 months for years 3-5, and then annually for years 6- ...

5. openurologyandnephrologyjournal.com openurologyandnephrologyjournal.com/VOLUME/17/ELOCATOR/e1874303X237036/FULLTEXT/

6-month Formulations of Androgen Deprivation Therapy for ... Effectiveness of subcutaneously administered leuprolide acetate to achieve low nadir testosterone in prostate cancer patients. Rev Urol 2018; 20 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05169112

Impact of Hormonal Therapy on Prostate Cancer ... ... cancer recurrence, 1 year of ADT immediately after surgery will be safe and will significantly improve cancer outcomes. Official Title. The Impact of ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3278745/

Efficacy and safety of leuprolide acetate 6-month depot for ... Leuprolide acetate 45 mg 6-month depot demonstrated rapid and sustained testosterone suppression through 12 months and was well tolerated.

8. lupronprostatecancer.com lupronprostatecancer.com/about-advanced-prostate-cancer

About Advanced Prostate Cancer Increased risk of heart attack, sudden death, and stroke can occur in men using LUPRON DEPOT. Discuss this increased risk with your doctor before starting ...