Semantic Coherence: XTANDI (Astellas Pharma Inc.) – Signal Evidence & AI Readability

[H1] XTANDI is approved to treat 4 types* of advanced prostate cancer

Learn about these 4 types

*metastatic castration sensitive prostate cancer (mCSPC); non-metastatic castration sensitive prostate cancer with high risk of cancer spreading (nmCSPC high-risk BCR); metastatic castration resistant prostate cancer (mCRPC); non-metastatic castration resistant prostate cancer (nmCRPC)

[IMG: Patient with family member]

[H2] Real patients. Real XTANDI Xperiences.

Gain perspectives into the lives of men living with prostate cancer and their family.

[IMG: Jim Confronts Returning Prostate Cancer video.]

[H2] Jim Confronts Returning Prostate Cancer

Watch his story

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[H2] Euvon & Janet: The Power of Support

Watch their story

[IMG: Mahlon’s Journey to Accessing XTANDI® Video]

[H2] Mahlon's Journey to Accessing XTANDI

Watch his story

[IMG: One piece at a time: Henry’s journey living with mCSPC video]

[H2] Henry's Journey— One Piece at a Time

Watch his story

[IMG: Janet]

[H2] Janet's Guide to Caring For Your Loved One—and Yourself

Watch her story

DOCTOR DISCUSSION GUIDE
[H2] Bring this guide to your next doctor's appointment

Take charge of your care. This guide is full of questions to ask your doctor about prostate cancer and XTANDI.

Get the guide

[IMG: Icon: Prostate cancer patient discussing XTANDI® with his doctor]

[H2] Select Safety Information

XTANDI may cause serious side effects including seizure.
If you take XTANDI, you may be at risk of having a seizure.
Avoid activities where a sudden loss of consciousness could seriously harm you or someone else.
Tell your doctor right away if you lose consciousness or have a seizure.
Learn more

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[H2] Sign up for support

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For more information on Financial Support, please call 1-855-898-2634

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Clinical Results
[H1] XTANDI is FDA-approved to treat 4 types of advanced prostate cancer

Looking for study results? Start by selecting a prostate cancer type below.

[IMG: XTANDI patient Mark.]

Mark, an XTANDI patientand clean water advocate

[H2] In multiple clinical studies, XTANDI was proven to delay cancer progression and helped men live longer.

[H3] Metastatic castration-sensitive prostate cancer (mCSPC)

Prostate cancer that has spread to other parts of the body and responds to hormone therapy or surgical treatment to lower testosterone.
[IMG: Icon: Alert]
Five-year overall survival outcomes data available

XTANDI was studied among 1,150 men with prostate cancer that had spread to other parts of the body and was still responding to hormone therapy or surgery to lower testosterone.

These men were divided into two groups:
574 received XTANDI + ADT (androgen deprivation therapy)
576 received ADT alone

During the study, all men continued ADT, either hormone therapy or surgery to lower testosterone.

[IMG: 61% less risk of cancer progression]

[H4] XTANDI slowed disease progression

[H5] Men who took XTANDI + ADT had 61% less risk of their cancer progressing compared to those who took ADT alone.

[IMG: Lightbulb icon]

This means the study found the XTANDI + ADT group had 61% less risk of cancer progressing.*

At the time of analysis, progression was seen in 89 out of 576 (16%) men in the XTANDI group, compared to 198 out of 574 (34%) men in the ADT-alone group.

Patients whose cancer progressed

[H6] XTANDI + ADT

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16 %

[H6] ADT ALONE

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34 %

*Progression was defined as the cancer getting worse, as measured by scans, or if the patient died for any reason.
The median length of time until the cancer got worse was not reached for patients taking XTANDI + ADT because more than half of the men were still alive. As opposed, the median length of time until the cancer got worse was 19 months with ADT alone. The median is not the average, but the middle of a set of numbers.

[IMG: 34% reduction in the risk of death]

[H4] In the same study, XTANDI helped men live longer (Overall Survival)

[H5] Men taking XTANDI had a 34% reduction in the risk of death compared with men not taking XTANDI.

[IMG: Lightbulb icon]

This means the study found the XTANDI + ADT group had a 34% reduction in the risk of death compared with men not taking XTANDI.

At the time of analysis, there were 154 out of 574 (27%) deaths in the XTANDI group, compared with 202 out of 576 (35%) deaths in the ADT-alone group.

Patients who experienced a fatal event

[H6] XTANDI + ADT

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27 %

[H6] ADT ALONE

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35 %

The median length of time patients lived after starting treatment was not reached for either treatment arm. The median is not the average, but the middle of a set of numbers.

[IMG: 72% improvement in delaying next-treatment]

[H5] In addition, patients receiving XTANDI had a 72% improvement in delaying the time before receiving the next cancer treatment, including chemo, compared with ADT alone.

[IMG: Icon: Alert]
Five-year follow-up on overall survival data
Investigators observed the number of patients who were alive around 5 years after patients started their treatment in the study. The study above was not designed to show a difference between the two treatment groups at 5 years. This means that these observations cannot tell us if there are differences in the results because of the treatment patients in each group received. Conclusions cannot be reached on this data, including which treatment is better or worse.

Unlike the main analysis shown above, the data did not undergo an additional independent review, and it was not used to support the FDA approval of XTANDI. Please speak with your doctor to better understand what this means for you.
[H5] Number of patients alive at 5 years

XTANDI + ADT
191 deaths out of 574 men

ADT ALONE223 deaths out of 576 men

Results may vary. Always talk with your doctor to best understand clinical data.
[H4] Select Safety Information

XTANDI may cause serious side effects including: seizure, a brain condition called PRES, allergic reactions, heart disease that can lead to death, falls and bone fractures, swallowing problems or choking that can lead to death. Learn more about possible side effects

[H3] Metastatic castration-resistant prostate cancer (mCRPC)

Prostate cancer that has spread to other parts of the body and no longer responds to a hormone therapy or surgical treatment to lower testosterone.

XTANDI was studied in 1,717 men with prostate cancer that had spread to other parts of the body and no longer responded to hormone therapy or surgical treatment to lower testosterone.

These men were divided into two groups:
872 received XTANDI + ADT (androgen deprivation therapy)
845 received ADT alone

During the study, all men continued ADT, either hormone therapy or surgery to lower testosterone.

[IMG: 83% less risk of cancer progression]

[H4] XTANDI slowed disease progression

[H5] Men taking XTANDI had an 83% lower chance of their cancer progressing compared with men not taking XTANDI.

[IMG: Lightbulb icon]

This means the study found the XTANDI + ADT group had 83% less risk of cancer progressing.*
At the time of analysis, progression was seen in 118 out of 832 (14%) men in the XTANDI group, compared with 320 out of 801 (40%) men in the ADT-alone group.

Patients whose cancer progressed

[H6] XTANDI + ADT

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14 %

[H6] ADT ALONE

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40 %

*Progression was defined as the cancer getting worse, as measured by scans, or if the patient died for any reason.
The median length of time until the cancer got worse was not reached for XTANDI + ADT vs. 4 months for ADT alone. The median is not the average, but the middle of a set of numbers.

[IMG: 23% reduction in risk of death]

[H4] In the same study, XTANDI helped men live longer (Overall Survival)

[H5] Men taking XTANDI had a 23% reduction in the risk of death compared with men not taking XTANDI.

[IMG: Lightbulb icon]

This means the study found the XTANDI + ADT group had a 23% reduction in the risk of death compared with men not taking XTANDI.
At the time of analysis, there were 368 out of 872 (42%) deaths in the XTANDI group, compared with 416 out of 845 (49%) deaths in the ADT-alone group.

Patients who experienced a fatal event

[H6] XTANDI + ADT

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42 %

[H6] ADT ALONE

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49 %

The median overall survival was 35 months for men taking XTANDI + ADT vs. 31 months for ADT alone. The median is not the average, but the middle of a set of numbers.

[IMG: 65% reduction in starting new chemotherapy]

[H4]

[H5] In addition, men taking XTANDI had a 65% reduction in risk of starting new chemotherapy and also delayed the median time before beginning chemotherapy.

The median time before beginning chemotherapy was 28 months for men taking XTANDI + ADT vs. 11 months for ADT alone. The median is not the average, but the middle of a set of numbers.

Results may vary. Always talk with your doctor to best understand clinical data.
[H4] Select Safety Information

XTANDI may cause serious side effects including: seizure, a brain condition called PRES, allergic reactions, heart disease that can lead to death, falls and bone fractures, swallowing problems or choking that can lead to death. Learn more about possible side effects

[H3] Non-metastatic castration-resistant prostate cancer (nmCRPC)

Prostate cancer that has not spread to other parts of the body and no longer responds to a hormone therapy or surgical treatment to lower testosterone.

XTANDI was studied in 1,401 men with prostate cancer that had not spread to other parts of the body and no longer responded to hormone therapy or surgical treatment to lower testosterone.

These men were divided into two groups:
933 received XTANDI + ADT (androgen deprivation therapy)
468 received ADT alone

During the study, all men continued ADT, either hormone therapy or surgery to lower testosterone.

[IMG: 71% less risk of cancer spreading]

[H4] XTANDI slowed disease spread

[H5] Men taking XTANDI had 71% less risk of their cancer spreading compared with men not taking XTANDI.

[IMG: Lightbulb icon]

This means the study found the XTANDI + ADT group had 71% less risk of cancer spreading.*
At the time of analysis, cancer spreading was seen in 219 out of 933 (24%) men in the XTANDI group, compared with 228 out of 468 (49%) men in the ADT-alone group.

PATIENTS WHOSE CANCER SPREAD

[H6] XTANDI + ADT

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24 %

[H6] ADT ALONE

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49 %

*Cancer was considered to be spreading if shown by scans or if the patient died for any reason.
The median length of time until the cancer spread was 37 months for XTANDI + ADT vs. 15 months for ADT alone. The median is not the average, but the middle of a set of numbers.

[IMG: 27% reduction in risk of death]

[H4] In the same study, XTANDI helped men live longer (Overall Survival)

[H5] Men taking XTANDI had a 27% reduction in the risk of death compared with men not taking XTANDI.

[IMG: Lightbulb icon]

This means the study found the XTANDI + ADT group had a 27% reduction in the risk of death compared with men not taking XTANDI.
At the time of analysis, there were 288 out of 933 (31%) deaths in the XTANDI group, compared to 178 out of 468 (38%) deaths in the ADT-alone group.

Patients who experienced a fatal event

[H6] XTANDI + ADT

[IMG: Red arrow]

31 %

[H6] ADT ALONE

[IMG: Outline arrow]

38 %

The median overall survival was 67 months for men taking XTANDI + ADT vs. 56 months for ADT alone. The median is not the average, but the middle of a set of numbers.

[IMG: 79% reduction in risk of starting next treatment]

[H4]

[H5] In addition, men taking XTANDI had a 79% reduction in risk of starting their next cancer treatment, including chemo. XTANDI also delayed the median time before men began chemotherapy.

The median time before beginning chemotherapy was 40 months for men taking XTANDI + ADT vs. 18 months for ADT alone. The median is not the average, but the middle of a set of numbers.

Results may vary. Always talk with your doctor to best understand clinical data.
[H4] Select Safety Information

XTANDI may cause serious side effects including: seizure, a brain condition called PRES, allergic reactions, heart disease that can lead to death, falls and bone fractures, swallowing problems or choking that can lead to death. Learn more about possible side effects

[H3] Non-metastatic castration-sensitive prostate cancer (nmCSPC) with high risk of cancer spreading

Prostate cancer in men that has not spread to other parts of the body and responds to a hormone therapy or surgical treatment to lower testosterone, and who are at a high risk of cancer spreading to other parts of the body.

XTANDI was studied in 1,068 men with prostate cancer:
That had not spread to other parts of the body and responds to a hormone therapy to lower testosterone
Who are at high risk of cancer spreading to other parts of the body
Who had not received chemotherapy and who all had prior surgery or radiation as definitive treatment

These men were divided into three groups:
355 received XTANDI + ADT (androgen deprivation therapy)
355 received XTANDI alone
358 received ADT alone

The median length of time until the cancer spread was not reached for any treatment arm. Cancer was considered to be spreading if shown by scans or if the patient died for any reason. The median is not the average, but the middle of a set of numbers.

[IMG: 58% less risk of cancer spreading with XTANDI® + ADT]

[H4] XTANDI + ADT slowed disease progression

[H5] Men taking XTANDI + ADT had a 58% lower chance of their cancer spreading compared with men taking ADT alone.

[IMG: Lightbulb icon]

This means the study found the XTANDI + ADT group had 58% less risk of cancer spreading.*
At the time of analysis, cancer spreading was seen in 45 out of 355 (13%) men in the XTANDI + ADT group, compared with 92 out of 358 (26%) men in the ADT-alone group.

PATIENTS WHOSE CANCER SPREAD

[H6] XTANDI + ADT

[IMG: Red arrow]

13 %

[H6] ADT ALONE

[IMG: Outline arrow]

26 %

[IMG: 37% less risk of cancer spreading with XTANDI alone]

[H4] XTANDI alone slowed disease progression

[H5] Men taking XTANDI alone had a 37% lower chance of their cancer spreading compared with men taking ADT alone.

[IMG: Lightbulb icon]

This means the study found the XTANDI group had 37% less risk of cancer spreading.
At the time of analysis, cancer spreading was seen in 63 out of 355 (18%) men in the XTANDI + ADT group, compared with 92 out of 358 (26%) men in the ADT-alone group.

PATIENTS WHOSE CANCER SPREAD

[H6] XTANDI

[IMG: Red arrow]

18 %

[H6] ADT ALONE

[IMG: Outline arrow]

26 %

This trial is ongoing to determine the effect on overall survival.
A medication holiday may be recommended by your doctor. This means you may take a break from your treatment. The length of your break will be determined by your doctor.
*Cancer was considered to be spreading if shown by scans or if the patient died for any reason.
The median length of time until the cancer spread was not reached for any treatment arm. The median is not the average, but the middle of a set of numbers.

Results may vary. Always talk with your doctor to best understand clinical data.
[H4] Select Safety Information

XTANDI may cause serious side effects including: seizure, a brain condition called PRES, allergic reactions, heart disease that can lead to death, falls and bone fractures, swallowing problems or choking that can lead to death. Learn more about possible side effects

[H2] Discover more XTANDI resources

[H3] Real people, real stories

Hear firsthand from men who

Doctor Discussion Guide
[H1] Questions for your next appointment

[IMG: Doctor discussing XTANDI® with patient.]

Your health is a team effort, and you can be a key player. We’ve created this guide full of questions to ask your doctor about advanced prostate cancer and XTANDI® (enzalutimide).

Download this guide (PDF)

XTANDI possible side effects

[H2] Self-assessment

[IMG: Icon: Notepad]

In addition to living longer, what are your treatment goals? For many people with advanced prostate cancer, these can include:

Delaying cancer progression
Understanding test results, including PSA
Delaying the start of chemotherapy
Medication that only has to be taken once a day
Understanding treatment options
Understanding the side effects
Other: ___________________

[H2] Start a conversation about XTANDI

[IMG: Icon: Communicate with your doctor]

Can XTANDI help patients:

Live longer?
Delay the progression or spread of cancer?
Lower the chances of having to start a new chemotherapy regimen?

When is the right time to start XTANDI?

Are there benefits of starting XTANDI now?

What are the potential side effects?

Will my insurance cover XTANDI?

Can I get assistance paying for XTANDI?

How do I take XTANDI? How often do I need to take XTANDI?

Do I need to take XTANDI with food?

How extensively has XTANDI been studied, tested, and used in patients?

[H2] Discover more XTANDI resources

[H3] Patient resources

Helpful XTANDI resources for patients and caregivers

Explore resources

[H3] Real people, real stories

Hear firsthand from men who are taking XTANDI

Watch their stories

[H3] Sign up for support emails and resources

We’re here for you with tools, tips, information, and support

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[H1] Want to learn more about XTANDI? We’re here to help

For education resources about XTANDI® (enzalutamide), along with helpful information, including patient stories, questions to ask your doctor, and more sent directly to your inbox, fill out the form below.

[H2] Discover more XTANDI resources

[H3] Frequently asked questions

You may have more questions. We have answers!

Review FAQs

[H3] Real people, real stories

Hear firsthand from men who are taking XTANDI

Watch their stories

[H3] Patient resources

Helpful XTANDI resources for patients and caregivers

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