How effective is Erleada (apalutamide)?

Medically reviewed by Melisa Puckey, BPharm. Last updated on May 1, 2024.

Official answer

by Drugs.com

Erleada (apalutamide) is used for nonmetastatic castration-resistant prostate cancer (nmCRPC) and for metastatic, castration-sensitive prostate cancer (mCSPC).

Nonmetastatic Castration-Resistant Prostate Cancer (nmCRPC)

The SPARTAN clinical trial (NCT01946204) for nmCRPC studied how effective Erleada was at increasing the time before prostate cancer had spread to other parts of the body, or time before death occurred. Patients who were in the apalutamide group had a median metastasis-free survival 24.3 months longer before cancer spread to other parts of the body or before death occurred, when compared to the placebo group.

The median metastasis-free survival for nmCRPC was:

40.5 months in the apalutamide group
16.2 months in the placebo group
This means the apalutamide group of patients lived a median of 24.3 months longer without progressing to metastasis or death (40.5 -16.2= 24.3 months).

Metastatic, Castration-Sensitive Prostate Cancer (mCSPC).

The TITAN clinical trial (NCT02489318) for mCSPC looked at whether the addition of apalutamide to androgen-deprivation therapy (ADT) would increase radiographic progression–free survival and also increase overall survival, when compared with placebo plus ADT. Radiographic progression–free survival is the length of time before imaging shows cancer has progressed or death occurs.

Radiographic progression–free survival

The results of the TITAN trial show that at 24 months the percentage of mCSPC patients with radiographic progression–free survival was:

68.2% in the apalutamide + ADT group
47.5% in the placebo + ADT group
Meaning the apalutamide + ADT group had 20.7% more patients who reached 24 months without radiographic progression of their cancer. (68.2%-47.5%=20.7%)

Overall survival

Effectiveness of apalutamide on mCSPC was also measured by overall survival in each group after 24 months:

82.4% in the apalutamide + ADT group were still alive
73.5% in the placebo + ADT group were still alive
This means that after 24 months there were more patients surviving in the apalutamide + ADT group compared to the placebo + ADT group.

Bottom line:

Nonmetastatic castration-resistant prostate cancer (nmCRPC) patients on apalutamide lived a median of 24.3 months longer without progressing to metastasis or death (40.5 - 16.2 = 24.3 months) when compared to the placebo group.
A larger percentage of metastatic, castration-sensitive prostate cancer (mCSPC) patients on apalutamide + ADT reached 24 months without radiographic progression of their cancer, compared to the placebo + ADT group.
More of the metastatic, castration-sensitive prostate cancer (mCSPC) patients in the apalutamide + ADT treatment group were still alive after 24 months, compared to placebo + ADT group.

Why has Xtandi stopped working and what do I take next?

Prostate cancer cells, like bacteria, can evolve over time and become resistant to treatments, including the hormone therapy and androgen receptor inhibitor Xtandi (enzalutamide). The cancer cells work to reprogram their environment and develop strategies that enable them to transform and survive.

If treatment with Xtandi stops working then other treatments may be offered, such as:

Chemotherapy
Immunotherapy
Targeted therapy
Radiotherapy

Stopping treatment with Xtandi may also result in an antiandrogen withdrawal response (AAWR), which can cause the cancer to stop growing or shrink for the period of time. Continue reading

How long does Xtandi work?

Xtandi is typically taken until prostate cancer starts to progress or spread (metastasize), or until the patient can no longer tolerate therapy because of the side effects or adverse events it causes.

In clinical trials, Xtandi was effective at delaying the time to disease progression in men with advanced prostate cancer. In men who had not received prior treatment with chemotherapy, Xtandi was also effective at delaying the need for treatment with a cytotoxic chemotherapy agent.

In the AFFIRM trial, treatment with Xtandi extended life by almost 5 months in men with metastatic castration-resistant prostate cancer. Continue reading

Why is prednisone prescribed with Zytiga?

Zytiga is taken with prednisone to help manage side effects that might occur with this prostate cancer treatment. Zytiga blocks the production of cortisol from your adrenal glands. Prednisone helps to replace the lost cortisol that can cause side effects such as low blood potassium levels, fluid build up (edema), or high blood pressure. Continue reading

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