Winald Gerritsen, MD, PhD, professor and medical oncologist, Radboud Medical Center, discusses a phase II study that examined the efficacy and safety of alisertib monotherapy in patients with neuroendocrine prostate cancer, an aggressive, androgen-independent subtype of castration-resistant prostate cancer.

Gerritsen explains that the researchers in this study took biopsies from patients who were progressing on different therapies and discovered that, for several of them, their disease was more accurately characterized as neuroendocrine prostate cancer, rather than prostate adenocarcinoma.

The results of the study demonstrated that single-agent alisertib yielded a 6-month progression-free survival rate of 16.3% in patients with pathologically confirmed neuroendocrine prostate cancer. Moreover, 2 patients achieved complete response for liver metastases.

Twenty-three patients experienced grade 3/4 toxicities, the most common of which were neutropenia, gastrointestinal side effects, fatigue, and febrile neutropenia, anemia, and elevated bilirubin.

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Winald Gerritsen, MD, PhD, professor and medical oncologist, Radboud Medical Center, discusses a phase II study that examined the activity of alisertib monotherapy in patients with neuroendocrine prostate cancer.

Dr. Gerritsen on a Study of Alisertib in Neuroendocrine Prostate Cancer

Winald Gerritsen, MD, PhD, professor and medical oncologist, Radboud Medical Center, discusses some of the recent shortcomings seen with immunotherapy agents in the treatment of patients with castration-resistant prostate cancer (CRPC).

For example, ipilimumab (Yervoy), which is approved for the treatment of patients with metastatic melanoma, has been evaluated in multiple phase III studies as a treatment for patients with prostate cancer. Although one such study did not meet its primary endpoint of improved overall survival, prespecified subset analyses have suggested that ipilimumab may be more efficacious in men with lower disease burden. These findings suggest that immunotherapy should be tested early in men with CRPC.

One ongoing phase II study is evaluating how well PROSTVAC-V/F works in stopping prostate cancer from coming back or relapsing. This study will also look at the safety of PROSTVAC-V/F. The trial is currently enrolling patients who have recently undergone radical prostatectomy and are at high risk for relapse.

However, oncologists have seen more positive results with sipuleucel-T (Provenge), which is the first therapeutic cancer vaccine to be approved by the FDA as a treatment for men with metastatic CRPC and little to no symptoms. Sipuleucel-T is designed to elicit an immune response to prostatic acid phosphatase by using the patient’s own immune system to recognize and combat the cancer. The agent has been demonstrated to prolong median survival in these patients by 4.1 months compared with placebo.

Winald Gerritsen, MD, PhD, professor and medical oncologist, Radboud Medical Center, discusses some of the recent shortcomings seen with immunotherapy agents in the treatment of patients with castration-resistant prostate cancer.

Winald Gerritsen, MD, PhD

Articles

Dr. Gerritsen on a Study of Alisertib in Neuroendocrine Prostate Cancer

Dr. Gerritsen on Shortcomings of Immunotherapy in Prostate Cancer