Phase 4
N=206
Study on Enzalutamide and Flutamide in Patients With Castration Resistant Prostate Cancer
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02918968 ↗Enrolled (actual)
206
Serious AEs
19.5%
Results posted
May 2021
Primary outcome: Primary: Time to PSA Progression With 1st Line AAT (TTPP1) — 21.39; 5.78 Months — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Enzalutamide (Drug); Flutamide (Drug); Androgen deprivation therapy (Other)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- Male
- Sponsor
- Astellas Pharma Inc
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to PSA Progression With 1st Line AAT (TTPP1) |
21.39; 5.78 | <0.001 sig |
| SECONDARY Time to PSA Progression With 2nd Line AAT (TTPP2) |
NA; 21.22 | — |
| SECONDARY Percentage of Participants Achieving at Least 50 or 90 Percent (%) Reduction From Baseline and Up To Week 38 in Prostate Specific Antigen (PSA) Response at 1st Line AAT |
75.0; 48.0; 66.7; 0.0; 72.0; 32.0 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving at Least 50 or 90 Percent (%) Reduction From Baseline to Week 13 in Prostate Specific Antigen (PSA) Response at 1st Line AAT |
83.3; 40.0; 66.7; 0.0; 72.0; 33.3 | <0.001 sig |
| SECONDARY Time to PSA Decrease by 50% From Baseline With 1st Line AAT |
2.79; 3.94; 2.79; NA; 2.79; 7.49 | <0.001 sig |
| SECONDARY Time to Treatment Failure of 1st Line AAT (TTF1) |
17.58; 7.72; 5.55; 4.73; 12.02; 3.94 | <0.001 sig |
| SECONDARY Time to Treatment Failure of 2nd Line AAT (TTF2) |
23.03; 16.59 | — |
| SECONDARY Radiographic Progression-free Survival (rPFS) |
NA; NA | 0.669 |
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).
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02918968). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.