CLINICAL TRIALS PROFILE FOR CASODEX

505(b)(2) Clinical Trials for CASODEX

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT01416870 ↗	Bioequivalence of Bicalutamide New Formulation in Japan	Terminated	AstraZeneca	Phase 1	2010-07-01	The purpose of this study is to investigate the bioequivalence of Bicalutamide new formation with Casodex commercial tablet (80mg) in Japanese healthy male subjects

All Clinical Trials for CASODEX

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002855 ↗	Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer	Completed	National Cancer Institute (NCI)	Phase 3	1996-08-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy and androgen suppression may kill more tumor cells. It is not yet known which treatment regimen is more effective for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy plus hormone therapy versus androgen suppression alone as initial therapy in patients with prostate cancer that is metastatic or that cannot be removed surgically.
NCT00002855 ↗	Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer	Completed	M.D. Anderson Cancer Center	Phase 3	1996-08-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy and androgen suppression may kill more tumor cells. It is not yet known which treatment regimen is more effective for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy plus hormone therapy versus androgen suppression alone as initial therapy in patients with prostate cancer that is metastatic or that cannot be removed surgically.
NCT00002874 ↗	Radiation Therapy With or Without Bicalutamide for Recurrent pT3N0 Prostate Cancer After Radical Prostatectomy	Unknown status	National Cancer Institute (NCI)	Phase 3	1998-02-01	RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using bicalutamide may fight prostate cancer by reducing the production of androgens. It is not yet known if radiation therapy is more effective with or without bicalutamide for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without bicalutamide in treating patients who have stage II or stage III prostate cancer and elevated prostate-specific antigen (PSA) levels following radical prostatectomy.
NCT00002874 ↗	Radiation Therapy With or Without Bicalutamide for Recurrent pT3N0 Prostate Cancer After Radical Prostatectomy	Unknown status	NRG Oncology	Phase 3	1998-02-01	RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using bicalutamide may fight prostate cancer by reducing the production of androgens. It is not yet known if radiation therapy is more effective with or without bicalutamide for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without bicalutamide in treating patients who have stage II or stage III prostate cancer and elevated prostate-specific antigen (PSA) levels following radical prostatectomy.
NCT00002874 ↗	Radiation Therapy With or Without Bicalutamide for Recurrent pT3N0 Prostate Cancer After Radical Prostatectomy	Unknown status	Southwest Oncology Group	Phase 3	1998-02-01	RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using bicalutamide may fight prostate cancer by reducing the production of androgens. It is not yet known if radiation therapy is more effective with or without bicalutamide for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without bicalutamide in treating patients who have stage II or stage III prostate cancer and elevated prostate-specific antigen (PSA) levels following radical prostatectomy.
NCT00002874 ↗	Radiation Therapy With or Without Bicalutamide for Recurrent pT3N0 Prostate Cancer After Radical Prostatectomy	Unknown status	Radiation Therapy Oncology Group	Phase 3	1998-02-01	RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using bicalutamide may fight prostate cancer by reducing the production of androgens. It is not yet known if radiation therapy is more effective with or without bicalutamide for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without bicalutamide in treating patients who have stage II or stage III prostate cancer and elevated prostate-specific antigen (PSA) levels following radical prostatectomy.
NCT00003026 ↗	Hormone Therapy in Treating Patients With Advanced Prostate Cancer	Completed	European Organisation for Research and Treatment of Cancer - EORTC	Phase 3	1997-04-01	RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using triptorelin may fight prostate cancer by reducing the production of androgens. PURPOSE: Randomized phase III trial to compare the effectiveness of long-term hormone therapy and triptorelin with no further treatment in treating patients who have advanced prostate cancer previously treated with radiation therapy and 6 months of androgen suppression.

Clinical Trial Conditions for CASODEX

Condition Name

Condition Name for CASODEX
Intervention	Trials
Prostate Cancer	60
Adenocarcinoma of the Prostate	9
Stage IV Prostate Cancer	6
Recurrent Prostate Carcinoma	6

Condition MeSH

Condition MeSH for CASODEX
Intervention	Trials
Prostatic Neoplasms	84
Adenocarcinoma	17
Breast Neoplasms	6
Carcinoma	3

Clinical Trial Locations for CASODEX

Trials by Country

Trials by Country for CASODEX
Location	Trials
United States	588
Canada	44
Italy	27
United Kingdom	19
China	13

Trials by US State

Trials by US State for CASODEX
Location	Trials
California	25
Texas	25
New York	22
Illinois	21
Michigan	19

Clinical Trial Progress for CASODEX

Clinical Trial Phase

Clinical Trial Phase for CASODEX
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	23
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for CASODEX
Clinical Trial Phase	Trials
Completed	54
Active, not recruiting	16
Terminated	12

Clinical Trial Sponsors for CASODEX

Sponsor Name

Sponsor Name for CASODEX
Sponsor	Trials
National Cancer Institute (NCI)	26
AstraZeneca	16
M.D. Anderson Cancer Center	7

Sponsor Type

Sponsor Type for CASODEX
Sponsor	Trials
Other	99
Industry	54
NIH	27

CASODEX Market Analysis and Financial Projection

Last updated: April 28, 2026

Clinical Trials Update, Market Analysis, and Projections for Casodex (bicalutamide)

Casodex (bicalutamide) is an orally administered non-steroidal androgen receptor inhibitor used in advanced prostate cancer. Most late-stage development activity is historical, and the near-term commercial outlook is shaped mainly by ongoing generics, line-extensions in combination settings, and regional reimbursement and survivorship patterns rather than new pivotal filings.

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What clinical trials data and updates exist for Casodex (bicalutamide)?

Trial activity snapshot (public registry and literature record)

A sustained pattern exists of post-approval studies in prostate cancer that are primarily confirmatory, translational, or comparative in combination regimens. The most consistently used clinical endpoints are PSA response, time to progression, overall survival in advanced disease, and tolerability, especially gynecomastia and breast pain. The clinical base is anchored by Casodex’s established role in advanced prostate cancer and in combination strategies that reduce androgen stimulation while maintaining quality-of-life considerations.

Key clinical-knowledge points that continue to drive study design

• Core mechanism: androgen receptor blockade through competitive antagonism.
• Common regimen contexts:
  • Advanced prostate cancer (monotherapy in specific settings historically, and in combination in others)
  • Combination approaches with surgical or medical castration to improve disease control
• Typical safety focus: endocrine adverse events (gynecomastia, breast tenderness), liver enzyme elevations monitored in clinical protocols.

Evidence base underpinning current clinical positioning

• Prostate cancer androgen-deprivation strategy: bicalutamide is widely studied as part of androgen pathway inhibition. The drug label and regulatory review history establish it for advanced prostate cancer based on randomized clinical outcomes such as time to progression and survival endpoints in the advanced setting. (See Casodex product labeling and FDA/EMA materials.) [1–3]

Current-state implication for “clinical trials update”

Because Casodex is not a modern pipeline asset and pivotal development is largely complete, “updates” in the commercial sense usually come from:

• Updated comparative analyses versus other anti-androgens (steroidal and non-steroidal classes).
• Subgroup analyses that refine tolerability expectations in older populations.
• Translational studies (biomarkers, resistance mechanisms) that inform sequencing choices rather than new regulatory approvals.

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How is Casodex positioned in the current prostate cancer treatment landscape?

Positioning versus newer anti-androgens

Casodex’s market share is influenced by newer androgen receptor inhibitors (ARIs) used across metastatic and non-metastatic pathways. Casodex remains relevant where:

• formularies favor older, lower-cost therapies
• payers prioritize budget control and proven outcomes
• prescribers aim to manage cost while maintaining acceptable tolerability

The market impact is typically highest in settings where the health system has strong generic uptake and where clinical practice still uses earlier-generation ARIs for selected patient groups.

Use cases that still generate prescriptions

• Locally advanced and advanced prostate cancer treated with androgen pathway suppression.
• Combination with androgen deprivation therapy (ADT) in older protocols and in cost-sensitive systems.
• Patients for whom newer ARIs are less accessible due to reimbursement or patient-specific tolerability.

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What does the market look like and what are the drivers for demand?

Demand drivers

1. Generic pricing and availability

   • Once a drug passes patent exclusivity, market economics typically shift toward lowest net cost.
   • Casodex faces sustained generic competition, which supports volume but compresses value.

2. Payer formularies and substitution

   • In prostate cancer, ARIs are often grouped by clinical class and selected based on net price.
   • Casodex is commonly used when price is a primary decision variable.

3. Chronic treatment pattern

   • Advanced prostate cancer remains a long-duration indication; patients may stay on therapy across many months, supporting baseline demand even as the total addressable population is impacted by treatment migrations to newer agents.

4. Geographic variance

   • Countries with slower switching or entrenched ADT protocols can show more persistent use of bicalutamide-based regimens.

Value drivers

• Net price after rebates and generic competition
• Reimbursement rules for ARIs in advanced disease
• Switching behavior from older ARIs to newer ARIs

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How should market projections be modeled for Casodex (bicalutamide)?

Projection logic for a mature, generics-dominated asset

For Casodex, projections are best modeled using:

• Volume stability with value compression
• Indication shift effects (movement toward newer ARIs in metastatic/non-metastatic settings)
• Regional generic penetration rates

Because the drug is established and off-patent in most markets, the projection typically shows:

• modest volume changes (dependent on prostate cancer incidence and treatment uptake)
• sustained decline in value per unit
• episodic volatility tied to formulary updates or guideline changes in regions

Market outlook framework (directional)

• Base case: continued volume supported by generics and established protocols; pricing pressure limits revenue growth.
• Downside case: additional formulary displacement by newer ARIs in more regions and line settings.
• Upside case: continued cost-sensitive uptake and stable advanced disease management patterns.

Practical business takeaways for projections

• Model unit sales as linked to advanced prostate cancer prevalence and ADT/ARI treatment adoption.
• Model revenue as unit sales times net price, where net price trends downward under generic substitution.
• Track regional net price and formulary inclusion as leading indicators.

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What competitive and regulatory factors could change the trajectory?

Competition

• Newer anti-androgens with broader label coverage and strong guideline placement in metastatic settings pressure Casodex substitution, especially where health systems move aggressively to newer ARIs.
• Generic competition also creates a “multiple low-price offers” market that can sustain scripts but not premium revenue.

Regulatory and labeling

Casodex labeling defines its approved use in advanced prostate cancer contexts. Ongoing regulatory upkeep is usually administrative (safety updates, labeling revisions), not major new clinical expansions. [1–3]

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What are the key endpoints and safety themes that still shape clinical use?

Safety profile themes that matter for prescribing and payer restrictions

• Gynecomastia and breast pain: class-consistent and managed via monitoring and patient selection.
• Hepatic monitoring: protocols often include liver function checks, especially in long-duration therapy.

Clinical endpoint themes that still appear in practice

• PSA response rates
• Time to progression
• Overall survival in advanced disease
• Quality-of-life considerations driven by endocrine side effects

These themes drive both clinician decision-making and payer policies for prior authorization and step therapy, even in mature markets. [1–3]

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Key Takeaways

• Casodex (bicalutamide) is a mature, generics-led prostate cancer ARI with clinical activity centered on long-established outcomes in advanced disease rather than new pivotal development.
• Market demand is supported by chronic treatment patterns and cost-sensitive use, while revenue is constrained by generic competition and substitution to newer ARIs in metastatic and guideline-driven settings.
• Projections should be built on unit-stable, price-down dynamics, with scenario outcomes driven mainly by formulary migration and regional net price trends rather than new clinical efficacy filings.
• Clinical practice updates tend to reflect comparative positioning and tolerability monitoring rather than fundamental label changes.

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FAQs

1) Is Casodex still used for prostate cancer today?

Yes. Casodex continues to be used in advanced prostate cancer regimens, especially where generic cost and established protocols favor bicalutamide-based androgen pathway inhibition. [1–3]

2) What limits Casodex revenue growth versus newer ARIs?

Net price compression from generics and increasing displacement by newer, higher-evidence ARIs in metastatic and non-metastatic settings reduce value per patient. [1–3]

3) What safety issues most often affect patient selection?

Gynecomastia and breast pain are the most consistent endocrine adverse events; hepatic monitoring is also a routine consideration in long-duration therapy protocols. [1–3]

4) What clinical endpoints define Casodex’s historical evidence?

PSA response, time to progression, and survival-related endpoints in advanced prostate cancer, alongside tolerability and quality-of-life measures. [1–3]

5) Do new pivotal trials drive the Casodex market today?

No. The drug’s pivotal phase is historical; market evolution is driven mainly by competitive displacement, generic penetration, and regional payer behavior rather than new regulatory-defining trials. [1–3]

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References

[1] U.S. Food and Drug Administration. Casodex (bicalutamide) prescribing information / label. FDA label documents.
[2] European Medicines Agency. Casodex (bicalutamide) product information. EMA assessment and EPAR materials.
[3] National Library of Medicine. Casodex (bicalutamide) clinical information and study records (PubMed / clinical trial listings).