CLINICAL TRIALS PROFILE FOR XTANDI

All Clinical Trials for XTANDI

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00268476 ↗	Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy	Recruiting	Medical Research Council	Phase 2/Phase 3	2005-07-08	The overall aim of this trial, which is called STAMPEDE, is to assess novel approaches for the treatment of men with prostate cancer who are starting long-term ADT for the first time, termed hormone-naïve prostate cancer. This trial aims to see if we can improve the way in which prostate cancer is currently managed, either by adding new treatments to the standard approach or by modifying the type of hormone therapy aiming to improve quality-of-life by reducing the side effects of treatment. Each new treatment approach is compared against a control arm receiving the current standard treatments. We aim to identify treatment strategies that enable men to live longer, or as long but with an improved quality-of-life, as well as offering value for money for the health service. Since opening to accrual in Oct-2005, the trial has tested many ways of treating prostate cancer and some results are now already known. More than 10,000 men will join the trial with answers becoming available throughout the trial. New patients joining the trial from Protocol version 17.0 onwards (activated in December 2018) may be eligible to join one of two treatment comparisons, metformin (treatment group K; the "metformin comparison") and transdermal oestradiol (treatment group L; the "transdermal oestradiol comparison"). A computer program will be used to allocate which treatment each participant receives, using a chance process. Summary of the research arms in STAMPEDE trial platform Summary of research treatment groups currently open to recruitment (June 2017) 1. Metformin (Arm K): This anti-diabetic medication is proposed to have both anti-cancer effects and may help prevent the adverse metabolic effects of long-term ADT. STAMPEDE will investigate whether adding metformin to the current standard-of-care for non-diabetic men can improve all-cause survival. 2. Transdermal oestradiol (Arm L): This is an alternative form of hormone treatment which has been shown to suppress testosterone as effectively as standard ADT and avoid some of the side-effects. It may also help to avoid the adverse metabolic effects and fatigue and therefore improve overall quality of life compared with standard forms of ADT. STAMPEDE will investigate whether transdermal oestradiol can treat the cancer as well as current standard forms of ADT. 3. Control group (Arm A): Patients allocated to this group receive the current standard-of-care ADT +/- RT +/- docetaxel.
NCT00510718 ↗	A Phase 1 Study of MDV3100 in Patients With Castration-Resistant (Hormone-Refractory) Prostate Cancer	Completed	Astellas Pharma Inc	Phase 1	2007-07-23	This is a multi-center open-label dose-escalation study of a novel compound (MDV3100) to treat patients with castration-resistant (hormone-refractory) prostate cancer. Additional patients will be enrolled in expanded cohorts at doses determined to be tolerable. Patients who tolerate the drug and do not progress will be allowed to continue to look for PSA response.
NCT00510718 ↗	A Phase 1 Study of MDV3100 in Patients With Castration-Resistant (Hormone-Refractory) Prostate Cancer	Completed	Medivation LLC, a wholly owned subsidiary of Pfizer Inc.	Phase 1	2007-07-23	This is a multi-center open-label dose-escalation study of a novel compound (MDV3100) to treat patients with castration-resistant (hormone-refractory) prostate cancer. Additional patients will be enrolled in expanded cohorts at doses determined to be tolerable. Patients who tolerate the drug and do not progress will be allowed to continue to look for PSA response.
NCT00510718 ↗	A Phase 1 Study of MDV3100 in Patients With Castration-Resistant (Hormone-Refractory) Prostate Cancer	Completed	Medivation, Inc.	Phase 1	2007-07-23	This is a multi-center open-label dose-escalation study of a novel compound (MDV3100) to treat patients with castration-resistant (hormone-refractory) prostate cancer. Additional patients will be enrolled in expanded cohorts at doses determined to be tolerable. Patients who tolerate the drug and do not progress will be allowed to continue to look for PSA response.

Clinical Trial Conditions for XTANDI

Condition Name

Condition Name for XTANDI
Intervention	Trials
Prostate Cancer	47
Castration-Resistant Prostate Carcinoma	13
Stage IV Prostate Cancer	13
Metastatic Castration-Resistant Prostate Cancer	11

Condition MeSH

Condition MeSH for XTANDI
Intervention	Trials
Prostatic Neoplasms	135
Carcinoma	20
Adenocarcinoma	18
Prostatic Neoplasms, Castration-Resistant	11

Clinical Trial Locations for XTANDI

Trials by Country

Trials by Country for XTANDI
Location	Trials
United States	643
United Kingdom	122
Canada	89
France	82
Spain	75

Trials by US State

Trials by US State for XTANDI
Location	Trials
California	41
New York	35
Texas	32
Maryland	29
Illinois	28

Clinical Trial Progress for XTANDI

Clinical Trial Phase

Clinical Trial Phase for XTANDI
Clinical Trial Phase	Trials
Phase 4	10
Phase 3	17
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for XTANDI
Clinical Trial Phase	Trials
Completed	46
Recruiting	45
Active, not recruiting	31

Clinical Trial Sponsors for XTANDI

Sponsor Name

Sponsor Name for XTANDI
Sponsor	Trials
Medivation, Inc.	47
Astellas Pharma Inc	31
National Cancer Institute (NCI)	25

Sponsor Type

Sponsor Type for XTANDI
Sponsor	Trials
Industry	197
Other	144
NIH	25

Clinical Trials Update, Market Analysis, and Projection for XTANDI

Last updated: October 15, 2025

Introduction

XTANDI (apalutamide) remains a pivotal therapy in the management of metastatic castration-resistant prostate cancer (mCRPC). Approved by the U.S. Food and Drug Administration (FDA) in 2018, XTANDI has established itself as a key player amid evolving prostate cancer treatment regimens. This report delivers a comprehensive overview of recent clinical trial developments, market dynamics, and future forecasts for XTANDI, assisting stakeholders in strategic planning and investment decisions.

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Clinical Trials Update

Current and Ongoing Trials

As of early 2023, numerous clinical trials investigate XTANDI’s broader therapeutic potential. Notably, the SPARTAN (NCT01946204) and PROSPER (NCT02003924) trials established the efficacy of apalutamide (marketed as Erleada) in non-metastatic castration-resistant prostate cancer (nmCRPC), prompting comparative and combination studies involving XTANDI.

Recently, attention has shifted to trials assessing XTANDI in earlier disease stages and in combination with other agents:

• Precision Oncology Trials: Multiple phase 2 and 3 trials evaluate the combination of XTANDI with immunotherapies such as PD-1 inhibitors, targeting potential synergistic effects in prostate cancer.

• Trial NCT04868634: A phase 3 trial assessing XTANDI plus radiotherapy vs. radiotherapy alone in non-metastatic high-risk prostate cancer, aiming to expand XTANDI’s indications.

• NCT04540896: Investigates XTANDI with chemotherapy agents like docetaxel in metastatic hormone-sensitive prostate cancer (mHSPC), an explorative indication that could broaden its use.

Recent Data Highlights

Recent data from the SPARTAN and PROSPER trials demonstrate significant survival benefits:

• SPARTAN: Showed a hazard ratio (HR) of 0.28 for metastasis-free survival versus placebo, reinforcing apalutamide’s role in delaying metastasis [2].

• PROSPER: Demonstrated a median metastasis-free survival of 36.6 months with apalutamide versus 14.7 months with placebo (HR 0.28), emphasizing its efficacy in non-metastatic settings.

While these trials pertain to apalutamide, comparisons underscore the importance of ongoing studies evaluating XTANDI’s specific benefits across different stages and combinations.

Regulatory Advancements

In 2022, the FDA approved XTANDI for the treatment of high-risk non-metastatic castration-resistant prostate cancer following the results from the SPARTAN trial. This approval marked a significant expansion, positioning XTANDI as a frontline agent in earlier disease stages and reflecting positive clinical trial outcomes.

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Market Analysis

Historical Market Performance

Since its initial launch in 2018, XTANDI has rapidly gained market share in prostate cancer therapeutics, outperforming traditional androgen deprivation therapies (ADTs) and competing with agents like enzalutamide and darolutamide.

• Market Size (2022): The global prostate cancer drug market was valued at approximately $4.3 billion, with XTANDI accounting for about 40% of the market share, translating roughly to $1.7 billion in revenue [3].

• Sales Trends: The drug has seen continuous growth driven by expanding indications, increased adoption in clinical guidelines, and heightened awareness among physicians.

Competitive Landscape

XTANDI faces competition primarily from:

• Enzalutamide (Xtandi): Marketed by Pfizer and Astellas, with a similar mechanism but slightly different side effect profile.

• Darolutamide (Zejula): Recently gaining traction for non-metastatic settings.

• Novel Agents & Biosimilars: As patent protections evolve, biosimilar development poses potential price and market share compression.

Market Drivers

• Expanded Indications: Recent label expansions to include high-risk nmCRPC and potential combinations in mHSPC.

• Guideline Endorsements: Adoption by NCCN and ESMO guidelines continues to endorse XTANDI as standard care.

• Patient Preference: Oral administration and tolerability favor patient adherence.

Market Challenges

• Pricing & Reimbursement: High drug costs remain barriers in certain healthcare systems.

• Competition: Evolving therapies and biosimilars could restrain growth.

• Clinical Trial Outcomes: Pending results from ongoing studies will influence future prescribing patterns.

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Market Projection

Forecast Period (2023-2030)

Based on current trends and pending clinical trial results, the market for XTANDI is projected to grow at a compound annual growth rate (CAGR) of 8-10% over the next decade.

Key Growth Factors

• Increased Penetration in Early-Stage Prostate Cancer: As evidence solidifies, XTANDI’s use in nmCRPC and mHSPC is expected to expand, contributing to revenue gains.

• Geographical Expansion: Markets in Asia-Pacific, Latin America, and the Middle East are projected to see increased adoption due to rising prostate cancer incidence and improving healthcare infrastructure.

• Pipeline Success: Positive outcomes from trials in combination therapies and new indications could substantially boost sales.

Potential Market Limitations

• Price sensitivities and reimbursement challenges in certain regions may temper growth.

• Competition from upcoming agents and biosimilars may erode market share.

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Strategic Implications for Stakeholders

• Pharmaceutical Companies: Investment in clinical trials focusing on earlier disease stages and combination regimens could offer competitive advantage.

• Investors: Monitoring trial outcomes and regulatory approvals is crucial for valuation adjustments.

• Healthcare Providers: Incorporating emerging evidence into treatment planning will optimize patient outcomes.

• Policy Makers: Facilitating access and reimbursement will be vital as indications expand.

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Key Takeaways

• Ongoing trials are investigating XTANDI in earlier prostate cancer stages and in combination with immunotherapies, with positive preliminary data.

• Regulatory approvals are increasingly favoring expanded indications, particularly for high-risk non-metastatic settings.

• Market growth is expected to sustain at an 8-10% CAGR through 2030, driven by indication expansion, geographic rollout, and evolving treatment paradigms.

• Competitive pressures from enzalutamide, darolutamide, and biosimilars necessitate strategic positioning and innovation efforts.

• Stakeholders should closely monitor clinical trial outcomes, regulatory landscapes, and market access policies to optimize decision-making.

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FAQs

1. What are the recent clinical trial highlights for XTANDI?
Recent trials focus on assessing XTANDI in earlier prostate cancer stages and in combination with other therapies. The positive results from the SPARTAN and PROSPER trials have facilitated expanded indications, especially in non-metastatic castration-resistant settings.

2. How does XTANDI compare to its competitors?
While all three main agents — XTANDI, enzalutamide, and darolutamide — target androgen receptor signaling, XTANDI has demonstrated strong efficacy and favorable safety in expanding indications. Its competitive edge lies in its tolerability profile and emerging evidence supporting early-stage use.

3. What factors are driving XTANDI’s market growth?
Market growth is primarily driven by regulatory approvals for new indications, incorporation into clinical guidelines, increasing diagnosis rates, and wider geographic adoption, especially in emerging markets.

4. What are the potential challenges facing XTANDI’s market expansion?
Main challenges include high drug costs, reimbursement hurdles, intense competition, and uncertainties from ongoing clinical trial results influencing future approvals and prescribing practices.

5. What is the long-term market outlook for XTANDI?
The outlook remains optimistic, with projected growth fueled by continued indication expansion, combination therapy trials, and geographic penetration. However, emerging competitors and pricing pressures could influence market dynamics.

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References

[1] Smith MR, et al. “Apalutamide and Clinical Outcomes in Nonmetastatic Castration-Resistant Prostate Cancer,” The New England Journal of Medicine, 2018.

[2] Zhao H, et al. “Metastasis-Free Survival as a Surrogate for Overall Survival in Prostate Cancer Trials,” The Lancet Oncology, 2020.

[3] MarketWatch. “Prostate Cancer Drugs Market Size, Shares, Growth, Trends.” 2022.