CLINICAL TRIALS PROFILE FOR ZOLADEX

All Clinical Trials for zoladex

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002597 ↗	Radiation Therapy With or Without Antiandrogen Therapy in Treating Patients With Stage I or Stage II Prostate Cancer	Completed	National Cancer Institute (NCI)	Phase 3	1994-10-01	RATIONALE: Radiation therapy (RT) uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using flutamide, goserelin, and leuprolide may fight prostate cancer by reducing the production of androgens. It is not yet known which regimen of antiandrogen therapy is most effective for prostate cancer. PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy with or without antiandrogen therapy in treating patients who have stage I or stage II prostate cancer.
NCT00002597 ↗	Radiation Therapy With or Without Antiandrogen Therapy in Treating Patients With Stage I or Stage II Prostate Cancer	Completed	Radiation Therapy Oncology Group	Phase 3	1994-10-01	RATIONALE: Radiation therapy (RT) uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using flutamide, goserelin, and leuprolide may fight prostate cancer by reducing the production of androgens. It is not yet known which regimen of antiandrogen therapy is most effective for prostate cancer. PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy with or without antiandrogen therapy in treating patients who have stage I or stage II prostate cancer.
NCT00003645 ↗	Randomized Trial of Adjuvant Hormonal Therapy in Surgically Treated Prostate Cancer Patients at High Risk for Recurrence	Terminated	AstraZeneca	Phase 3	1999-06-14	RATIONALE: Testosterone can stimulate the growth of prostate cancer cells. Hormone therapy using leuprolide and flutamide may fight prostate cancer by reducing the production of testosterone. It is not yet known whether receiving leuprolide and flutamide is more effective than receiving no further therapy. PURPOSE: Randomized phase III trial to determine the effectiveness of hormone therapy in treating patients who have stage I or stage II prostate cancer that is at high risk of recurrence and who have already undergone surgery.
NCT00003645 ↗	Randomized Trial of Adjuvant Hormonal Therapy in Surgically Treated Prostate Cancer Patients at High Risk for Recurrence	Terminated	Eastern Cooperative Oncology Group	Phase 3	1999-06-14	RATIONALE: Testosterone can stimulate the growth of prostate cancer cells. Hormone therapy using leuprolide and flutamide may fight prostate cancer by reducing the production of testosterone. It is not yet known whether receiving leuprolide and flutamide is more effective than receiving no further therapy. PURPOSE: Randomized phase III trial to determine the effectiveness of hormone therapy in treating patients who have stage I or stage II prostate cancer that is at high risk of recurrence and who have already undergone surgery.

Clinical Trial Conditions for zoladex

Condition Name

Condition Name for zoladex
Intervention	Trials
Prostate Cancer	56
Breast Cancer	28
Prostate Adenocarcinoma	11
Stage III Prostate Cancer	8

Condition MeSH

Condition MeSH for zoladex
Intervention	Trials
Prostatic Neoplasms	85
Breast Neoplasms	47
Adenocarcinoma	21
Carcinoma	5

Clinical Trial Locations for zoladex

Trials by Country

Trials by Country for zoladex
Location	Trials
United States	622
Canada	39
China	24
United Kingdom	15
Japan	12

Trials by US State

Trials by US State for zoladex
Location	Trials
California	31
Texas	28
Massachusetts	23
Maryland	22
Florida	19

Clinical Trial Progress for zoladex

Clinical Trial Phase

Clinical Trial Phase for zoladex
Clinical Trial Phase	Trials
Phase 4	11
Phase 3	42
Phase 2/Phase 3	4

Clinical Trial Status

Clinical Trial Status for zoladex
Clinical Trial Phase	Trials
Completed	63
Recruiting	22
Active, not recruiting	20

Clinical Trial Sponsors for zoladex

Sponsor Name

Sponsor Name for zoladex
Sponsor	Trials
National Cancer Institute (NCI)	35
AstraZeneca	17
M.D. Anderson Cancer Center	9

Sponsor Type

Sponsor Type for zoladex
Sponsor	Trials
Other	169
Industry	76
NIH	39

Zoladex Market Analysis and Financial Projection

Zoladex: Clinical Trials, Market Analysis, and Projections

Introduction to Zoladex

Zoladex, also known as goserelin, is a luteinizing hormone-releasing hormone (LHRH) agonist used in the treatment of various hormone-sensitive cancers, including prostate cancer, breast cancer, and endometriosis. Here, we will delve into the recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials Overview

Comparison with Orchiectomy and Diethylstilbestrol (DES)

In a significant clinical trial, Zoladex was compared with orchiectomy and diethylstilbestrol (DES) in the treatment of advanced prostate cancer. The study found no significant difference between Zoladex and orchiectomy in terms of subjective and objective responses, endocrine responses, clinical effects, side effects, time to treatment failure, and survival. However, Zoladex was superior to DES in achieving an early objective response and had fewer side effects, making it a viable medical alternative to orchiectomy and DES[1].

Breast Cancer Trials

A Phase 3 clinical trial compared the efficacy and safety of Zoladex 10.8 mg administered every 12 weeks with Zoladex 3.6 mg administered every 4 weeks in pre-menopausal women with estrogen receptor-positive advanced breast cancer. This open-label, randomized study aimed to evaluate the female hormone and study medication characteristics. Patients in both groups also received oral tamoxifen. The study highlighted the efficacy and safety profiles of both dosages, with the 10.8 mg dose offering a more convenient administration schedule[3].

Another study, a Phase 4 real-world study, compared the effectiveness of Zoladex 10.8 mg and 3.6 mg in the treatment of premenopausal and perimenopausal hormone receptor-positive breast cancer. This observational study aimed to analyze the effectiveness over a maximum observation time window of 28 weeks[4].

Market Analysis

Global Market Size and Growth

The global Zoladex market has shown steady growth, driven by the increasing prevalence of hormone-related cancers such as breast and prostate cancer, as well as the rising elderly population. As of 2023, the global Zoladex market size was estimated to be USD 1.05 billion. It is projected to reach USD 1.28 billion by 2032, growing at a compound annual growth rate (CAGR) of 2.3% during the forecast period[5].

Market Segmentation

The Zoladex market is segmented based on type and application. The types include 3.6 mg and 10.8 mg formulations, while the applications include prostate cancer, breast cancer, endometriosis, and other conditions. The market analysis helps in understanding the key industry segments and their global, regional, and country-level insights. The report also identifies the most lucrative segments and their expected growth rates and future market opportunities[2].

Regional Analysis

The global Zoladex market is segmented into five major regions: North America, Europe, Asia-Pacific, Middle East & Africa, and Latin America. Each region's market dynamics, trends, drivers, restraints, and opportunities are analyzed to provide a comprehensive understanding of the market's geographical trends[2].

Key Players

AstraZeneca and TerSera are among the top companies dominating the Zoladex market. Other competitors include Pfizer Inc, Meditrina Pharmaceuticals Inc, Neurocrine Biosciences Inc, Abbott Laboratories, Bayer HealthCare Pharmaceuticals Inc, AEterna Zentaris Inc, Dr. Reddy's Laboratories, and Glaxo Smith Kline[2].

Market Drivers and Restraints

Drivers

• Increasing Prevalence of Hormone-Related Cancers: The rising incidence of breast and prostate cancer is a significant driver for the Zoladex market.
• Rising Elderly Population: The elderly population is more prone to hormone-related cancers, contributing to the market growth[5].

Restraints

• Side Effects: Although Zoladex has a favorable side effect profile compared to some other treatments, it can still cause flare symptoms during the initial stages of treatment.
• Competition: The presence of other LHRH agonists and alternative treatments can pose a competitive challenge to Zoladex[1][2].

Future Projections

Market Growth

The Zoladex market is expected to continue growing, driven by the increasing demand for effective treatments for hormone-sensitive cancers. The forecasted CAGR of 2.3% from 2024 to 2032 indicates a steady and stable growth trajectory[5].

Technological and Regulatory Trends

Advancements in drug delivery systems and ongoing clinical trials to expand the indications for Zoladex are expected to influence the market positively. Regulatory approvals and changes in healthcare policies will also play a crucial role in shaping the market's future[2].

Key Takeaways

• Clinical Trials: Zoladex has been shown to be effective and safe in various clinical trials, including comparisons with orchiectomy and DES, and in the treatment of breast cancer.
• Market Size and Growth: The global Zoladex market is projected to grow from USD 1.05 billion in 2023 to USD 1.28 billion by 2032 at a CAGR of 2.3%.
• Market Segmentation: The market is segmented by type (3.6 mg and 10.8 mg) and application (prostate cancer, breast cancer, endometriosis, etc.).
• Key Players: AstraZeneca and TerSera are among the leading companies in the Zoladex market.
• Drivers and Restraints: The market is driven by the increasing prevalence of hormone-related cancers and the rising elderly population, but faces restraints such as side effects and competition.

FAQs

What is the expected market size of Zoladex by 2032?

The Zoladex market is expected to reach USD 1.28 billion by 2032[5].

What is the CAGR of the Zoladex market from 2024 to 2032?

The Zoladex market is expected to exhibit a CAGR of 2.3% from 2024 to 2032[5].

What are the primary applications of Zoladex?

The primary applications of Zoladex include prostate cancer, breast cancer, and endometriosis[2].

Who are the key players in the Zoladex market?

AstraZeneca and TerSera are among the top companies in the Zoladex market[2].

What are the main drivers of the Zoladex market growth?

The main drivers include the increasing prevalence of hormone-related cancers and the rising elderly population[5].

Sources

1. Phase III studies to compare goserelin (Zoladex) with orchiectomy ... - PubMed
2. Zoladex Market Report 2024 (Global Edition) - Cognitive Market Research
3. Study to Compare Zoladex™ 10.8 mg with Zoladex 3.6 mg in Pre ... - AstraZeneca Clinical Trials
4. Zoladex® 10.8 BC RWS - AstraZeneca Clinical Trials - AstraZeneca Clinical Trials
5. Zoladex Market Size, Share, Growth, Trends Statistics Report, 2032 - Business Research Insights