CLINICAL TRIALS PROFILE FOR LUTRATE DEPOT KIT

All Clinical Trials for Lutrate Depot Kit

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01786265 ↗	Finite Androgen Ablation With or Without Abiraterone Acetate and Prednisone in Treating Patients With Recurrent Prostate Cancer	Active, not recruiting	Janssen Services, LLC	Phase 2	2013-02-05	This phase II trial studies how well finite androgen ablation with or without abiraterone acetate and prednisone work in treating patients with prostate cancer that has come back. Androgen can cause the growth of prostate cancer cells. Hormone therapy, such as finite androgen ablation, using leuprolide acetate, goserelin acetate, degarelix, bicalutamide, flutamide, and nilutamide may fight prostate cancer by lowering the amount of androgen the body makes. Abiraterone acetate may help to decrease the production of testosterone, and prednisone may help lower or prevent some side effects. It is not yet known whether giving acetate, goserelin acetate, degarelix, bicalutamide, flutamide, and nilutamide with or without abiraterone acetate and prednisone may work better in treating patients with prostate cancer.
NCT01786265 ↗	Finite Androgen Ablation With or Without Abiraterone Acetate and Prednisone in Treating Patients With Recurrent Prostate Cancer	Active, not recruiting	M.D. Anderson Cancer Center	Phase 2	2013-02-05	This phase II trial studies how well finite androgen ablation with or without abiraterone acetate and prednisone work in treating patients with prostate cancer that has come back. Androgen can cause the growth of prostate cancer cells. Hormone therapy, such as finite androgen ablation, using leuprolide acetate, goserelin acetate, degarelix, bicalutamide, flutamide, and nilutamide may fight prostate cancer by lowering the amount of androgen the body makes. Abiraterone acetate may help to decrease the production of testosterone, and prednisone may help lower or prevent some side effects. It is not yet known whether giving acetate, goserelin acetate, degarelix, bicalutamide, flutamide, and nilutamide with or without abiraterone acetate and prednisone may work better in treating patients with prostate cancer.
NCT04423211 ↗	Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Using PET/CT Imaging	Recruiting	National Cancer Institute (NCI)	Phase 3	2020-10-08	This phase III trial compares the addition of apalutamide, with or without targeted radiation therapy, to standard of care treatment versus standard of care treatment alone in patients with prostate cancer biochemical recurrence (a rise in the blood level of prostate-specific antigen [PSA] after treatment with surgery or radiation). Diagnostic procedures, such as positron emission tomography/computed tomography (PET/CT), may help doctors look for cancer that has spread to the pelvis. Androgens can cause the growth of prostate cancer cells. Apalutamide may help fight prostate cancer by blocking the use of androgens by the tumor cells. Targeted radiation therapy uses high energy rays to kill tumor cells and shrink tumors that have spread. This trial may help doctors determine if using PET/CT results to deliver more tailored treatment (i.e., adding apalutamide, with or without targeted radiation therapy, to standard of care treatment) works better than standard of care treatment alone in patients with biochemical recurrence of prostate cancer.
NCT04423211 ↗	Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Using PET/CT Imaging	Recruiting	ECOG-ACRIN Cancer Research Group	Phase 3	2020-10-08	This phase III trial compares the addition of apalutamide, with or without targeted radiation therapy, to standard of care treatment versus standard of care treatment alone in patients with prostate cancer biochemical recurrence (a rise in the blood level of prostate-specific antigen [PSA] after treatment with surgery or radiation). Diagnostic procedures, such as positron emission tomography/computed tomography (PET/CT), may help doctors look for cancer that has spread to the pelvis. Androgens can cause the growth of prostate cancer cells. Apalutamide may help fight prostate cancer by blocking the use of androgens by the tumor cells. Targeted radiation therapy uses high energy rays to kill tumor cells and shrink tumors that have spread. This trial may help doctors determine if using PET/CT results to deliver more tailored treatment (i.e., adding apalutamide, with or without targeted radiation therapy, to standard of care treatment) works better than standard of care treatment alone in patients with biochemical recurrence of prostate cancer.
NCT04484818 ↗	Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [ADT]) After Surgery for Men With High-Risk Prostate Cancer, The ERADICATE Study	Recruiting	National Cancer Institute (NCI)	Phase 3	2020-12-09	This phase III trial compares the effect of adding darolutamide to ADT versus ADT alone after surgery for the treatment of high-risk prostate cancer. ADT reduces testosterone levels in the blood. Testosterone is a hormone made mainly in the testes and is needed to develop and maintain male sex characteristics, such as facial hair, deep voice, and muscle growth. It also plays role in prostate cancer development. Darolutamide blocks the actions of the androgens (e.g. testosterone) in the tumor cells and in the body. Giving darolutamide with ADT may work better in eliminating or reducing the size of the cancer and/or prevent it from returning compared to ADT alone in patients with prostate cancer.

Clinical Trial Conditions for Lutrate Depot Kit

Condition Name

Condition Name for Lutrate Depot Kit
Intervention	Trials
Prostate Adenocarcinoma	2
Biochemically Recurrent Prostate Carcinoma	2
Stage IV Prostate Cancer AJCC v8	2
Stage IVA Prostate Cancer AJCC v8	2

Condition MeSH

Condition MeSH for Lutrate Depot Kit
Intervention	Trials
Prostatic Neoplasms	5
Carcinoma	2
Adenocarcinoma	2
Granulosa Cell Tumor	1

Clinical Trial Locations for Lutrate Depot Kit

Trials by Country

Trials by Country for Lutrate Depot Kit
Location	Trials
United States	44

Trials by US State

Trials by US State for Lutrate Depot Kit
Location	Trials
California	4
Illinois	3
Texas	3
Wisconsin	2
Pennsylvania	2

Clinical Trial Progress for Lutrate Depot Kit

Clinical Trial Phase

Clinical Trial Phase for Lutrate Depot Kit
Clinical Trial Phase	Trials
Phase 3	2
Phase 2	5

Clinical Trial Status

Clinical Trial Status for Lutrate Depot Kit
Clinical Trial Phase	Trials
Recruiting	3
Suspended	1
Active, not recruiting	1

Clinical Trial Sponsors for Lutrate Depot Kit

Sponsor Name

Sponsor Name for Lutrate Depot Kit
Sponsor	Trials
National Cancer Institute (NCI)	6
ECOG-ACRIN Cancer Research Group	2
M.D. Anderson Cancer Center	2

Sponsor Type

Sponsor Type for Lutrate Depot Kit
Sponsor	Trials
Other	6
NIH	6
Industry	1

Lutrate Depot Kit: Clinical Trials, Market Analysis, and Projections

Introduction to Lutrate Depot Kit

Lutrate Depot Kit, a formulation of leuprolide acetate, is a gonadotropin-releasing hormone (GnRH) agonist used in the treatment of various medical conditions, including prostate cancer, endometriosis, uterine fibroids, and precocious puberty. This article provides an update on the clinical trials, market analysis, and projections for Lutrate Depot Kit.

Clinical Trials and Efficacy

Clinical Trial Overview

The efficacy of Lutrate Depot 22.5 mg was evaluated in an open-label, multicenter, non-controlled, multiple-dose clinical trial. This trial enrolled 162 evaluable patients who were treated for 24 weeks, with 157 out of 163 patients receiving two injections[1].

Adverse Reactions and Safety

During the trial, common adverse reactions reported in 5% or more of the patients included hot flushes, upper respiratory infections, fatigue, diarrhea, pollakiuria, arthralgia, injection site pain, and constipation. Grade 3-4 adverse reactions were reported in 13% of patients, with 4% considered treatment-related[1].

Laboratory Abnormalities

The trial also noted significant changes in laboratory values, including anemia, increased triglyceride, hyperglycemia, increased cholesterol, increased creatine kinase, leukopenia, increased AST, increased creatinine, and increased ALT in more than 10% of the patients[1].

Comparative Studies

A phase III study comparing the depot formulation of leuprolide to daily subcutaneous injections showed that the depot formulation was safe and effective in treating advanced prostatic cancer. The study found that serum testosterone levels decreased to within the castrate range by week 3 of treatment, with no significant difference in safety and efficacy compared to the daily formulation[3].

Market Analysis

Market Size and Growth Projections

The leuprolide acetate market, which includes Lutrate Depot Kit, is anticipated to experience significant growth. As of 2022, the market size was valued at over USD 2 billion and is projected to reach approximately USD 3.5 billion by 2032 at a Compound Annual Growth Rate (CAGR) of 6%[2][5].

Growth Drivers

Several factors are driving the growth of the leuprolide acetate market:

Increasing Prevalence of Cancer

The rising incidence of cancers, particularly prostate cancer and breast cancer, is a significant driver. In Europe, these cancers account for a substantial portion of all cancer diagnoses[2].

Endometriosis Treatment

The growing female population suffering from endometriosis is another key factor. Endometriosis affects approximately 176 million women worldwide and 11% of American women between the ages of 15 to 44[2].

Veterinary Use

The demand for leuprolide acetate in veterinary treatments also contributes to the market's growth[2].

Product Forms and Distribution Channels

Lutrate Depot Kit is available in various forms, each with its own market dynamics:

Prefilled Syringes

Prefilled syringes are expected to gain a robust revenue share due to their convenience, accuracy, and safety. These syringes are disposable and maintain the drug's potency throughout its shelf life[2].

Intramuscular Kits and Powders

The drug is also available as intramuscular kits and powders for injection, extended release. These forms are popular due to their ease of administration and effectiveness[2][5].

Distribution Channels

The distribution channels include retail pharmacies, hospital pharmacies, and online pharmacies, each with its own market share and growth potential[2].

Pricing Dynamics

The pricing of Lutrate Depot Kit varies based on the dosage and form of the medication. For example, a 7.5 mg/month intramuscular kit can cost around $2,161.94, highlighting the significant costs associated with each kit or powder for injection[2].

Challenges and Regulatory Updates

Drug Price Control Policies

Strict drug price-control policies can hinder market expansion by standardizing medication costs, which can reduce R&D funding and impact business growth[2].

Regulatory Changes

InvaGen Pharmaceuticals was informed that it could remove the word “palliative” from the already approved use of its gonadotropin-releasing hormone agonist for the treatment of advanced prostate cancer, mirroring a similar change approved for Lupron Depot by AbbVie[4].

Market Projections and Future Outlook

Market Growth

The leuprolide acetate market is expected to grow significantly, driven by the increasing prevalence of cancer, the growing need for endometriosis treatment, and the demand for veterinary use. The market is projected to reach USD 3.5 billion by 2032 at a CAGR of 6% or USD 2,400 million by 2030 at a CAGR of 10.50%[2][5].

Increasing Use in Puberty Suppression Therapy

The significant demand for intramuscular injections for therapeutic use, including puberty suppression therapy in transgender and gender-diverse youth, is forecasted to boost the intramuscular segment growth. A study found that 69% of biochemical suppression occurred in intramuscular Lupron with no hormonal progression[5].

Key Takeaways

• The leuprolide acetate market, including Lutrate Depot Kit, is expected to grow significantly due to increasing cancer prevalence and the growing need for endometriosis treatment.
• The market is projected to reach USD 3.5 billion by 2032 at a CAGR of 6% or USD 2,400 million by 2030 at a CAGR of 10.50%.
• Prefilled syringes and intramuscular kits are dominant forms due to their convenience, accuracy, and safety.
• Pricing varies widely based on dosage and form, with significant costs associated with each kit or powder for injection.
• Drug price-control policies pose a challenge to market growth.

FAQs

1. What is Lutrate Depot Kit used for? Lutrate Depot Kit is used for the treatment of prostate cancer, endometriosis, uterine fibroids, and precocious puberty[2].

2. What is the projected market size of leuprolide acetate by 2032? The market is projected to reach approximately USD 3.5 billion by 2032[2][5].

3. What are the main growth drivers for the leuprolide acetate market? The main growth drivers include the increasing prevalence of cancer, the growing need for endometriosis treatment, and the demand for veterinary use[2].

4. How much does a typical dose of Lutrate Depot Kit cost? The cost varies, but for example, a 7.5 mg/month intramuscular kit can cost around $2,161.94[2].

5. Are there any challenges facing the leuprolide acetate market? Yes, strict drug price-control policies can hinder market expansion by reducing R&D funding and impacting business growth[2].

Sources

1. RxList: Lutrate Depot (Leuprolide Acetate for Depot Suspension) - RxList.
2. Drug Patent Watch: Pharmaceutical drug prices and trends for LUPRON DEPOT.
3. PubMed: Clinical study of leuprolide depot formulation in the treatment of advanced prostatic cancer.
4. ACCC-Cancer.org: New Molecular Entities None Changes in Labeled Indications.
5. GlobeNewswire: Leuprolide Acetate Market to hit USD 3.5 Billion by 2032, says Global Market Insights Inc.