Clinical Results

XTANDI is FDA-approved to treat 4 types of advanced prostate cancer

XTANDI patient Ken.

Ken, an XTANDI patient and woodworking enthusiast

In multiple clinical studies, XTANDI® (enzalutamide) was proven to delay cancer progression and helped men live longer

XTANDI slowed disease progression

XTANDI was studied in 1,150 men with advanced prostate cancer that:

  • Was still responsive to hormone therapy or surgical treatment to lower testosterone
  • Had spread to other parts of the body

These men were given either XTANDI + ADT (Androgen Deprivation Therapy) (574 men) or ADT alone (576 men).

All men either had surgery to lower testosterone or continued to take hormone therapy during the study.

Men taking XTANDI had a 61% lower chance of their cancer progressing compared with men not taking XTANDI during the study. Progression was seen in 89 men (15.5%) in XTANDI + ADT, and 198 men (34.4%) in ADT alone.

The median* length of time until the cancer got worse was not reached for XTANDI + ADT vs. 19 months for ADT alone.

Progression was defined as the cancer getting worse, as measured by scans, or if the patient died for any reason.

*The median is not the average, but the middle of a set of numbers.

In the same study, XTANDI helped men live longer (Overall Survival).

Men taking XTANDI had a 34% reduction in the risk of death compared with men not taking XTANDI during the study. 154 deaths (26.8%) in XTANDI + ADT vs. 202 deaths (35.1%) in ADT alone.

The median length of time patients lived after starting treatment was not reached for either treatment arm.

In addition, patients receiving XTANDI had a 72% improvement in delaying the time before receiving the next treatment, including chemo.

Results may vary. Talk with your doctor about what this may mean for you.

Select safety information

XTANDI may cause serious side effects including falls and bone fractures. XTANDI treatment may increase your risk for falls and bone fractures. Falls were not caused by loss of consciousness or seizures. Your doctor will monitor your risks for falls and bone fractures during treatment with XTANDI. Learn more

XTANDI slowed disease progression

XTANDI was studied in 1,717 men with advanced prostate cancer that:

  • No longer responded to hormone therapy or surgical treatment to lower testosterone
  • Had spread to other parts of the body

These men were given either XTANDI + ADT (Androgen Deprivation Therapy) (872 men) or ADT alone (845 men).

These men had not received chemotherapy. All men either had surgery to lower testosterone or continued to take hormone therapy during the study.

Men taking XTANDI had an 83% lower chance of their cancer progressing compared with men not taking XTANDI during the study. Progression was seen in 118 men (14%) in XTANDI + ADT and 320 men (40%) in ADT alone.

The median* length of time until the cancer got worse was not reached for XTANDI + ADT vs. 4 months for ADT alone.

Progression was defined as the cancer getting worse, as measured by scans, or if the patient died for any reason.

*The median is not the average, but the middle of a set of numbers.

In the same study, XTANDI helped men live longer (Overall Survival).

Men taking XTANDI had a 23% reduction in the risk of death compared with men not taking XTANDI during the study. 368 deaths (42%) in XTANDI + ADT vs. 416 deaths (49%) in ADT alone.

The median overall survival was 35 months for men taking XTANDI + ADT vs. 31 months for ADT alone.

The following numbers are the median.*

*The median is not the average, but the middle of a set of numbers.

Taking xtandi (months)

35

Not Taking xtandi (months)

31

In addition, XTANDI delayed the median time before men began chemotherapy.

During the study, men taking XTANDI had a 65% reduction in risk of starting a new chemotherapy and also delayed the median time before men began chemotherapy: 28 months for men taking XTANDI compared with 11 months for men not taking XTANDI.

The following numbers are the median.*

*The median is not the average, but the middle of a set of numbers.

Taking xtandi (months)

28

Not Taking xtandi (months)

11

Results may vary. Talk with your doctor about what this may mean for you.

Select safety information

XTANDI may cause serious side effects including falls and bone fractures. XTANDI treatment may increase your risk for falls and bone fractures. Falls were not caused by loss of consciousness or seizures. Your doctor will monitor your risks for falls and bone fractures during treatment with XTANDI. Learn more

XTANDI slowed disease spread

XTANDI was studied in 1,401 men with advanced prostate cancer that:

  • No longer responded to hormone therapy or surgical treatment to lower testosterone
  • Had not spread to other parts of the body

These men were given either XTANDI + ADT (Androgen Deprivation Therapy) (933 men) or ADT alone (468 men).

These men had not received chemotherapy. All men either had surgery to lower testosterone or continued to take hormone therapy during the study.

Men taking XTANDI had a 71% lower chance of their cancer spreading compared with men not taking XTANDI during the study. Cancer spreading was seen in 219 men (23.5%) in XTANDI + ADT, and 228 men (48.7%) in ADT alone.

The median* length of time until the cancer spread was 37 months for XTANDI + ADT vs. 15 months for ADT alone.

Cancer was considered to be spreading if shown by scans or if the patient died for any reason.

In the same study, XTANDI helped men live longer (Overall Survival).

Men taking XTANDI had a 27% reduction in the risk of death compared with men not taking XTANDI during the study. There were 288 deaths (30.9%) in XTANDI + ADT vs. 178 deaths (38%) in ADT alone.

The median overall survival was 67 months for men taking XTANDI vs. 56 months for ADT alone.

The following numbers are the median.*

*The median is not the average, but the middle of a set of numbers.

Taking xtandi (months)

67

Not Taking xtandi (months)

56

In addition, XTANDI delayed the median time before men began their next cancer treatment, including chemo.

During the study, men taking XTANDI had a 79% reduction in risk of starting their next cancer treatment, including chemo. The delay in the median time was 39 months for men taking XTANDI compared with 17 months for men not taking XTANDI.

The following numbers are the median.*

*The median is not the average, but the middle of a set of numbers.

Taking xtandi (months)

39

Not Taking xtandi (months)

17

Results may vary. Talk with your doctor about what this may mean for you.

Select safety information

XTANDI may cause serious side effects including falls and bone fractures. XTANDI treatment may increase your risk for falls and bone fractures. Falls were not caused by loss of consciousness or seizures. Your doctor will monitor your risks for falls and bone fractures during treatment with XTANDI. Learn more

XTANDI slowed disease spread

XTANDI + ADT
XTANDI ALONE

XTANDI was studied in 1,068 men with advanced prostate cancer:

  • That had not spread to other parts of the body
  • That responds to a hormone therapy to lower testosterone
  • Who are at high risk of cancer spreading to other parts of the body

These men were given either XTANDI + ADT (Androgen Deprivation Therapy) (355 men), XTANDI alone (355 men), or ADT* alone (358 men).

Men taking XTANDI + ADT had a 58% lower chance of their cancer spreading compared with men taking ADT alone during the study. Cancer spreading was seen in 45 men (13%) in XTANDI + ADT, and 92 men (26%) in ADT alone.

In the same study, men taking XTANDI alone had a 37% lower chance of their cancer spreading compared with men taking ADT alone. Cancer spreading was seen in 63 men (18%) in XTANDI alone, and 92 men (26%) in 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.

This trial is ongoing to determine the effect on overall survival.

*ADT=Androgen deprivation therapy, leuprolide.

The median is not the average, but the middle of a set of numbers.

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.

Results may vary. Talk with your doctor about what this may mean for you.

Select Safety Information

XTANDI may cause serious side effects including falls and bone fractures. XTANDI treatment may increase your risk for falls and bone fractures. Falls were not caused by loss of consciousness or seizures. Your doctor will monitor your risks for falls and bone fractures during treatment with XTANDI. Learn more

Learn more about XTANDI

Real people, real stories

Hear firsthand from men who are taking XTANDI

Doctor discussion guide

Need to prepare for your next doctor’s visit?

Clinical glossary

Explore our glossary of prostate cancer terms