Phase 4
Completed N=509
Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients
Source: ClinicalTrials.gov NCT01995513 ↗Enrolled (actual)
509
Serious AEs
32.6%
Results posted
Nov 2017
Primary outcomePrimary: Progression Free Survival (PFS) — 5.7; 5.6 months — p=0.2176
◆ Published Evidence
Highly cited
171citations · ~21 / year
Abiraterone Alone or in Combination With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer With Rising Prostate-Specific Antigen During Enzalutamide Treatment.
Summary
The purpose of this study is to determine if continued treatment with Enzalutamide is effective in patients with metastatic prostate cancer.
Linked Publications
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Abiraterone Alone or in Combination With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer With Rising Prostate-Specific Antigen During Enzalutamide Treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) |
5.7; 5.6 | 0.2176 |
| SECONDARY Time to Prostate Specific Antigen (PSA) Progression |
2.8; 2.8 | 0.4500 |
| SECONDARY Prostate Specific Antigen (PSA) Response Rate |
0.8; 2.5; 2.4; 2.5 | 0.3101 |
| SECONDARY Objective Response Rate (ORR) |
0.0; 5.0; 68.4; 57.5 | 0.1653 |
| SECONDARY Rate of Pain Progression |
36.2; 27.1 | 0.2963 |
| SECONDARY Time to First Use of New Antineoplastic Therapy for Prostate Cancer |
10.3; 8.6 | 0.3818 |
| SECONDARY Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score |
116.4; 119.0; -3.3; -2.2; -4.4; -0.5 | — |
| SECONDARY Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores |
22.1; 22.4; -0.5; -0.8; -0.4; -0.4 | — |
| SECONDARY Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores |
18.1; 18.5; -0.1; 0.1; -0.1; 0.2 | — |
| SECONDARY Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores |
20.2; 20.3; -1.0; -0.7; -1.2; -0.4 | — |
| SECONDARY Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores |
33.2; 34.2; -0.7; -0.9; -1.9; -0.1 | — |
| SECONDARY Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores |
22.9; 23.6; -0.8; 0.1; -1.0; 0.0 | — |
| SECONDARY Time to Degradation of the Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score |
4.6; 6.4 | 0.0739 |
Eligibility Criteria
Inclusion Criteria
- Men with metastatic castration-resistant prostate cancer
- Progressive disease on androgen deprivation therapy
- Patients must agree to continue androgen deprivation therapy with a GnRH agonist/antagonist throughout the study or have had a prior bilateral orchiectomy
- ECOG performance score ≤ 1
- Estimated life expectancy of ≥ 12 months
Exclusion Criteria
- Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone, or enzalutamide for the treatment of prostate cancer
- Prior participation in a clinical trial of an investigational agent that inhibits the androgen receptor or androgen synthesis (unless the treatment was placebo)
- History of brain metastasis, active leptomeningeal disease or seizure
- Severe cardiovascular or hepatic disease
- Pituitary or adrenal dysfunction
Data sourced from ClinicalTrials.gov (NCT01995513) and the linked publication. 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. Informational only — not medical advice.