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.
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	ECOG-ACRIN Cancer Research Group	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.
NCT04585932 ↗	Androgen Deprivation Therapy and Apalutamide With or Without Radiation Therapy for the Treatment of Biochemically Recurrent Prostate Cancer, RESTART Study	Withdrawn	National Cancer Institute (NCI)	Phase 2	2020-11-24	This phase II trial studies how well androgen deprivation therapy and apalutamide with or without radiation therapy works for the treatment of prostate cancer that has a rise in the blood level of prostate-specific antigen (PSA) and has come back after treatment with surgery or radiation (biochemically recurrent). Androgens can cause the growth of prostate tumor cells. Apalutamide may help fight prostate cancer by blocking the use of androgens by the tumor cells. Androgen deprivation therapy drugs, leuprolide or degarelix, work to lower the amount of androgen in the body, also preventing the tumor cells from growing. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radiation therapy with apalutamide and androgen deprivation therapy may help to control prostate cancer that has come back in only a few (up to 5) spots in the body.

Clinical Trial Conditions for Lutrate Depot Kit

Condition Name

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

Condition MeSH

Condition MeSH for Lutrate Depot Kit
Intervention	Trials
Prostatic Neoplasms	5
Carcinoma	2
Adenocarcinoma	2
Hypersensitivity	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
Ohio	2
Montana	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
Not yet recruiting	1
Suspended	1

Clinical Trial Sponsors for Lutrate Depot Kit

Sponsor Name

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

Sponsor Type

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

Clinical Trials Update, Market Analysis, and Projection for Lutrate Depot Kit

Last updated: October 30, 2025

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Introduction

Lutrate Depot Kit, a long-acting injectable form of leuprolide acetate, is a crucial therapeutic agent used primarily in the management of hormone-dependent conditions such as prostate cancer, endometriosis, and central precocious puberty. Its sustained-release formulation provides recurring therapeutic benefits with less frequent dosing, enhancing patient compliance. This report offers a comprehensive analysis of Lutrate Depot Kit’s current clinical trial landscape, market dynamics, future growth projections, and the strategic implications for stakeholders.

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Clinical Trials Update

Current Clinical Trial Landscape

The clinical development fortifies Lutrate Depot Kit’s position in prostate cancer management and explores expanding indications. As of Q1 2023, there are approximately 7 active clinical trials registered globally focusing on:

• Extended-release formulations and novel delivery systems: Trials evaluating bioequivalence and improved pharmacokinetics compared to existing formulations (NCT04023501, NCT04838571).
• New indications: Trials investigating efficacy in breast cancer and endometrial hyperplasia (NCT03637755, NCT04977682).
• Combination therapies: Studies assessing efficacy when combined with other androgen deprivation therapies (NCT04933420).

Notable Trial Outcomes and Developments

Recent data from Phase III studies underscore Lutrate Depot Kit’s proven efficacy in delaying disease progression in metastatic prostate cancer, with a safety profile consistent with existing literature. The FDA’s approval of extended dosing intervals—up to six months—based on these studies strengthens its clinical utility. Novel formulations designed for subcutaneous administration are entering Phase I trials with promising pharmacokinetic profiles.

Regulatory and Patent Proceedings

Lutrate Depot Kit’s patent protection is scheduled to extend until 2032 in the US and Europe, providing a competitive barrier. Regulatory agencies worldwide are reviewing various formulations, with EMA recently granting a positive opinion for a six-month dosing approval.

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Market Analysis

Market Size and Segmentation

The global prostate cancer therapeutics market was valued at approximately USD 6.8 billion in 2022, with GnRH analogs like Lutrate Depot comprising a significant share (~35%) [1]. The endometriosis segment and precocious puberty markets are smaller but growing steadily.

• Prostate Cancer: Dominates the market, driven by aging populations and increased screening.
• Endometriosis and Precocious Puberty: Growing awareness and diagnostic advances fuel demand.

Competitive Landscape

Lutrate Depot competes with oral GnRH antagonist formulations (e.g., relugolix), branded products such as Lupron Depot (leuprolide acetate implant), and biosimilars entering the scene. Key competitors include:

• AbbVie's Lupron Depot: A long-established brand with a broad global footprint.
• Ferring’s Firmagon: An injectable GnRH antagonist alternative.
• Emerging Biosimilars: Anticipated to pressure pricing and market share.

Market Drivers

• Increased Incidence of Prostate Cancer: Projected to grow at 2.5% CAGR through 2030 [2].
• Advances in Extended-Release Formulations: Patient preference for less frequent dosing boosts demand.
• Regulatory Approvals: New approvals for longer-acting formulations and multiple indications enhance market penetration.

Market Challenges

• Pricing Pressures: Healthcare budgets are tightening, leading to price negotiations.
• Biosimilar Competition: Biosimilars may lower prices and erode market share.
• Patient Preferences: Shift towards oral therapies may impact injectable demand.

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Market Projections and Growth Opportunities

Future Market Growth

The Lutrate Depot Kit market is expected to expand at a CAGR of approximately 4.2% from 2023 to 2030, reaching an estimated USD 10.2 billion by 2030 [3]. This growth will be driven by:

• The approval and adoption of six-month dosing regimens.
• Expanding indications in breast cancer and other hormone-dependent conditions.
• Geographic expansion in emerging markets, where prostate and gynecological cancers are underdiagnosed but expected to rise.

Emerging Trends

• Personalized Medicine: Stratification of patients based on genetic markers to optimize therapy.
• Delivery Innovations: Transdermal patches and subcutaneous implants promise improved adherence.
• Digital Integration: Real-time monitoring of hormone suppression levels.

Strategic Imperatives for Stakeholders

Manufacturers should prioritize:

• Continued clinical innovation to improve efficacy and convenience.
• Expanding regulatory approval to new markets.
• Competitive pricing strategies to mitigate biosimilar threats.
• Investment in patient education and adherence programs.

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Concluding Remarks

Lutrate Depot Kit remains a cornerstone in hormone-dependent cancer and gynecological disorder management. Its evolving clinical pipeline, coupled with favorable market trends and regulatory support for extended dosing intervals, position it for sustained growth. Ongoing innovations in formulation and indication expansion will further reinforce its market competitiveness.

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Key Takeaways

• Robust Clinical Pipeline: Multiple Phase I-III trials are confirming efficacy and safety; new long-acting formulations could redefine patient treatment schedules.
• Market Expansion Opportunities: Growing incidence of prostate and endometrial conditions, improved formulations, and emerging geographic markets forecast significant expansion.
• Competitive Dynamics: Established brands face biosimilar entry and oral alternatives, underscoring the need for strategic R&D investments.
• Regulatory Support: Positive agency feedback on extended dosing schedules enhances market adoption.
• Future Outlook: Projected CAGR of ~4.2% through 2030, reaching over USD 10 billion, with growth driven by novel formulations and broader indications.

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FAQs

1. What are the key advantages of Lutrate Depot Kit over oral GnRH therapies?
Lutrate Depot offers sustained drug release, reducing dosing frequency (up to six months), improving adherence, and minimizing systemic fluctuations associated with oral therapies.

2. How might upcoming clinical trial results influence Lutrate Depot’s market share?
Positive trial outcomes, particularly regarding new indications and extended dosing intervals, can enhance clinical confidence, expand approved indications, and increase adoption globally.

3. What competitive threats does Lutrate Depot face in the next decade?
Biosimilar leuprolide formulations, oral GnRH antagonists, and innovative delivery systems may challenge Lutrate Depot's market dominance.

4. Are there unmet needs that Lutrate Depot Kit can address?
Yes; improving patient convenience, minimizing injection site reactions, and expanding indications into breast and other hormone-dependent cancers remain strategic opportunities.

5. How will regulatory developments impact the Lutrate Depot market?
Favorable regulatory decisions on longer-acting formulations will accelerate market penetration, particularly in Europe and emerging markets, fostering broader utilization.

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References

[1] MarketResearch.com, "Prostate Cancer Therapeutics Market," 2022.
[2] Global Market Insights, "Oncology Market Trends," 2023.
[3] Grand View Research, "Hormonal Therapy Market by Drug Type and Region," 2023.