Overview

Study on Enzalutamide and Flutamide in Patients With Castration Resistant Prostate Cancer

Status:
Completed
Trial end date:
2020-03-27
Target enrollment:
0
Participant gender:
Male
Summary
The objective of this study was to compare the efficacy and safety of the combination therapy with enzalutamide + androgen deprivation therapy (ADT) and the combination therapy with flutamide + ADT in patients with castration resistant prostate cancer who had relapsed during combined androgen blockade (CAB) therapy with bicalutamide and ADT. This study also investigated the order of alternative antiandrogen therapy (AAT) by changing the 1st line medication after relapse of prostate-specific antigen (PSA).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Astellas Pharma Inc
Collaborators:
Medivation, Inc.
Pfizer
Treatments:
Androgens
Flutamide
Criteria
Inclusion Criteria:

- Subject is diagnosed with histologically or cytologically confirmed adenocarcinoma of
the prostate without neuroendocrine differentiation or small-cell histology.

- Subject on continuous ADT with Gonadotropin Releasing Hormone (GnRH)
agonist/antagonist or bilateral orchiectomy.

- Serum testosterone level below the target level at screening visit.

- Subject with asymptomatic or mildly symptomatic prostate cancer.

- Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

- Subject has progression of the disease as defined by rising PSA levels or progressive
soft tissue or bony disease during CAB therapy in combination of bicalutamide and ADT.

- A sexually active male subject and the subject's female partner who is of childbearing
potential must use 2 acceptable birth control methods from screening to 3 months after
the last dose of the study drug.

- Subject must agree not to donate sperm from screening to 3 months after the last dose
of the study drug.

Exclusion Criteria:

- Subject with severe concurrent diseases, infections, or complications.

- Subject with confirmed or suspected brain metastasis or active leptomeningeal
metastasis.

- Subject with a history of malignant tumor other than prostate cancer in the past 5
years.

- Subject hypersensitive to the ingredients of enzalutamide capsules or flutamide
tablets.

- Subject with a history of convulsive attack, or prone to convulsive attack.

- Subject with liver disorder such as viral hepatitis and hepatic cirrhosis, or subject
with Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) at screening
visit higher than the upper limit of normal.

- Subject received treatment for prostate cancer with cytocidal chemotherapy that
includes anti androgenic agents other than bicalutamide, abiraterone, or estramustine.