Phase 2
Completed N=67
A Study to Test if Enzalutamide is Effective and Safe in Prostate Cancer Patients Who Have Never Had Hormone Therapy
Source: ClinicalTrials.gov NCT01302041 ↗Enrolled (actual)
67
Serious AEs
35.8%
Results posted
Apr 2016
Primary outcomePrimary: Percentage of Participants With a Prostate-Specific Antigen (PSA) Response at Week 25 — 92.5 Percentage of Participants
Summary
To evaluate the effect of enzalutamide on prostate specific antigen (PSA) level in men with prostate cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Prostate-Specific Antigen (PSA) Response at Week 25 |
92.5 | — |
| SECONDARY Number of Participants With Adverse Events |
67; 65; 5; 24; 5; 14 | — |
| SECONDARY Percent Change From Baseline in PSA |
-97.82; -98.96; -99.44; -91.74; -0.70 | — |
| SECONDARY Percent Change From Baseline in Sex Hormone-Binding Globulin (SHBG) |
100.60; 88.45 | — |
| SECONDARY Percent Change From Baseline in Androstenedione |
51.06; 49.94 | — |
| SECONDARY Percent Change From Baseline in Dehydroepiandrosterone (DHEA) |
9.59; 10.54 | — |
| SECONDARY Percent Change From Baseline in Dihydrotestosterone (DHT) |
51.72; 74.35 | — |
| SECONDARY Percent Change From Baseline in Estradiol |
71.69; 81.00 | — |
| SECONDARY Percent Change From Baseline in Follicle-Stimulating Hormone (FSH) |
46.99; 62.18 | — |
| SECONDARY Percent Change From Baseline in Luteinizing Hormone (LH) |
184.66; 215.18 | — |
| SECONDARY Percent Change From Baseline in Prolactin |
16.79; 9.64 | — |
| SECONDARY Percent Change From Baseline in Total Testosterone |
114.29; 101.73 | — |
| SECONDARY Percent Change From Baseline in Free Testosterone |
46.39; 43.74 | — |
| SECONDARY Plasma Concentration of Enzalutamide at Pre-dose (Ctrough) |
7.225; 10.559; 11.838; 12.161; 11.606; 11.868 | — |
| SECONDARY Plasma Concentration of Enzalutamide Metabolite M2 at Pre-dose (Ctrough) |
2.527; 5.344; 8.182; 9.962; 12.128; 12.780 | — |
| SECONDARY Percentage of Participants With a PSA Response at Weeks 49, 97 and 169 |
80.6; 67.2; 56.7 | — |
| SECONDARY Percentage of Participants With a 90% or Greater Reduction From Baseline in PSA Level |
91.0; 98.1; 100.0; 88.1 | — |
| SECONDARY Percentage of Participants With PSA ≤ 4 ng/ml |
92.5; 94.4; 100.0; 95.2 | — |
| SECONDARY Percentage of Participants With PSA ≤ 0.1 ng/ml |
44.8; 63.0; 73.3; 61.9 | — |
| SECONDARY Maximum Decline From Baseline in PSA |
-98.32; -99.10 | — |
| SECONDARY Time to PSA Response |
29 | — |
| SECONDARY Time to PSA Decline ≥ 90% |
55 | — |
| SECONDARY Time to PSA ≤ 4 ng/ml |
29 | — |
| SECONDARY Time to PSA ≤ 0.1 ng/ml |
168 | — |
| SECONDARY Time to PSA Progression |
NA | — |
| SECONDARY PSA Doubling Time |
— | — |
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed prostate cancer (all stages) for whom androgen deprivation therapy is indicated (except when indicated in a neoadjuvant/adjuvant therapy)
- Asymptomatic from prostate cancer
- Non-castrate level of testosterone (≥ 8 nmol/L (230 ng/dL)) at screening
- PSA ≥ 2 ng/mL at screening
Exclusion Criteria
Has previously or is currently receiving:
- Hormonal therapy with intent to treat prostate cancer
- Systemic glucocorticoids
- Chemotherapy with the intent to treat prostate cancer
- Opiate analgesics for pain from prostate cancer
- Radiation therapy for treatment of the primary tumor or metastases
- Has history of known or suspected brain or skull metastases or leptomeningeal disease
- Has history of seizure including febrile seizure or any condition that may predispose to seizure or history of loss of consciousness or transient ischemic attack
- Clinically significant cardiovascular disease
Data sourced from ClinicalTrials.gov (NCT01302041). 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.