Hormonal Therapy for Post-Surgery Prostate Cancer Recurrence
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Ottawa Hospital Research Institute
Must be taking: Androgen deprivation therapy
Disqualifiers: Lymph node metastases, others
Stay on Your Current Meds
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 4 Jurisdictions
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?
Is hormonal therapy for post-surgery prostate cancer recurrence safe?
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.15789
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.
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Trial 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 (Hormone Therapy)
Trial OverviewThe 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
2Treatment groups
Experimental Treatment
Active Control
Group I: Standard of Care plus Androgen Deprivation Therapy (Lupron Depot)Experimental Treatment1 Intervention
22.5 mg intra-muscular injection of Lupron Depot every 3 months for 12 months (4 injections total)
Group II: Standard of CareActive Control1 Intervention
Standard of Care
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The Ottawa HospitalOttawa, Canada
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Who Is Running the Clinical Trial?
Ottawa Hospital Research InstituteLead Sponsor
References
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]We evaluated the efficacy and tolerability of 3- and 6-month leuprorelin acetate (LA) depot formulations (Eligard®, Astellas Pharma GmbH) in patients with advanced prostate cancer treated in routine clinical practice in Germany.
Safety and efficacy of an implantable leuprolide delivery system in patients with advanced prostate cancer. [2019]We evaluated the pharmacokinetics, safety and efficacy of the implantable Viadur++ leuprolide delivery system during 12 months in patients with advanced prostate cancer.
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]The safety, efficacy and pharmacokinetics of a unique 3-month subcutaneous depot of leuprolide acetate were investigated in patients with prostate cancer.
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]To investigate the safety, efficacy, and pharmacokinetics of a new 4-month subcutaneous depot of leuprolide acetate in patients with prostate cancer.
Clinical experience with leuprorelin acetate before radiotherapy for prostatic cancer. [2017]A total of 40 patients with stages A2 to C prostatic cancer were treated with leuprorelin acetate depot once a month for 2 months before being treated by pelvic irradiation or radical prostatectomy. In the 32 patients who were evaluable, seven (22%) were classified as minor responders after leuprorelin treatment and 23 (72%) as major responders when assessed by rectal examination. Prostate-specific antigens also returned to normal concentrations (5 ng/ml) in 26/31 (84%) patients. Leuprorelin acetate depot suppressed plasma testosterone concentrations to castration values during treatment, but concentrations returned to normal 2 months after completion of treatment. Following radical treatment, there were three deaths--one postoperative and two due to recurrent disease--but there was no isolated local relapse. It is concluded that the protocol was locally well tolerated and was effective in the treatment of stages B2 and C prostatic cancer patients.
Effect of a new leuprorelin formulation on testosterone levels in patients with advanced prostate cancer. [2013]Leuprorelin is a well known luteinising hormone releasing hormone (LHRH) agonist. The drug is effective in the treatment of advanced prostate cancer and is well tolerated. This article reviews published literature (based on a search of PubMed, EMBASE and Biosis databases to the end of 2005) and other sources of data on a new formulation of leuprorelin acetate (Eligard) for use in the treatment of hormone-dependent advanced prostate cancer. This product takes advantage of a novel delivery system (Atrigel) which forms an implant in situ that is capable of delivering double doses of leuprorelin consistently to provide better, more sustained testosterone suppression compared with a microsphere leuprolide acetate formulation. Two formulations, 7.5 mg and 22.5 mg, are currently available with duration of action of 1 and 3 months, respectively. The 2-week stability at room temperature prior to mixing facilitates its use and reduces the potential for waste.
Managing advanced prostate cancer with Viadur (leuprolide acetate implant). [2013]Viadur (leuprolide acetate implant), providing a sustained release of drug over a 12-month duration, decreases serum testosterone in advanced prostate cancer patients, providing long-term, palliative medical hormonal therapy. Clinical experience suggests Viadur implants are safe, effective, and generally well tolerated. The continuous drug delivery provided by Viadur ensures compliance. The Viadur implants was designed to be maintenance-free, thereby allowing nurses and other health professionals to focus on other patient needs, such as followup visits and diagnostic tests. Viadur is one aspect of a comprehensive approach to patient management, which also includes regular followup for prostate-specific antigen testing, digital rectal examination, and other tests throughout the 1-year therapy.
Preliminary clinical evaluation of leuprorelin acetate depot injection in France, in the management of prostatic cancer. [2017]In a preliminary multicentre clinical trial of 3.75 mg leuprorelin acetate depot 18 previously untreated patients with metastatic prostatic cancer were treated with the depot given subcutaneously once every 4 weeks for 28 weeks. Patients also received 100 mg nilutamide taken orally three times a day for the first 14 days of treatment to prevent flare-up. Leuprorelin acetate suppressed the serum testosterone concentration to castration levels; luteinizing hormone levels were also suppressed. The incidence of progressive disease was low and partial response occurred in five patients after treatment. No side-effects were assigned to the flare-up period. It is concluded that leuprorelin acetate depot is a safe and efficacious treatment for metastatic prostatic cancer.
Leuprorelin depot injection: patient considerations in the management of prostatic cancer. [2021]Hormone therapy is well established for treating patients with prostate cancer and remains the mainstay of the treatment of metastatic and locally advanced disease, this article reviews the rationale for its use, its different forms, and complications and controversies still surrounding some of its modalities. Availability of long-acting synthetic luteinizing hormone-releasing hormone (LHRH) agonists revolutionized the hormonal treatment of prostate cancer, and helped to avoid the emotional and psychological effects related to surgical castration. The depot formula has gained wide acceptance from both patients and physicians. This review emphasizes the newer, long-acting formula, leuprorelin (leuprolide acetate), especially the 6-month formula, its advantage over over shorter-acting depot products, and its potential to become a standard of care for patients eligible for androgen deprivation therapy.