Trial Outcomes & Findings for Enzalutamide in Patients With High-risk Prostate Cancer (NCT NCT01927627)
NCT ID: NCT01927627
Last Updated: 2019-03-20
Results Overview
Clinical efficacy is measured as time to disease progression defined by biochemical recurrence (BCR). BCR was defined as PSA ≥0.2ng/mL on 2 consecutive lab results or any PSA rise that resulted in subsequent therapy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
2 years
Results posted on
2019-03-20
Participant Flow
Participant milestones
| Measure |
Enzalutamide
Oral therapy with enzalutamide at 160mg (4 capsules) orally once daily (QD).
enzalutamide: oral therapy with enzalutamide at 160mg (4 capsules) orally once daily (QD).
|
|---|---|
|
Overall Study
STARTED
|
42
|
|
Overall Study
COMPLETED
|
37
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Enzalutamide
Oral therapy with enzalutamide at 160mg (4 capsules) orally once daily (QD).
enzalutamide: oral therapy with enzalutamide at 160mg (4 capsules) orally once daily (QD).
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Financial Concerns
|
1
|
Baseline Characteristics
Enzalutamide in Patients With High-risk Prostate Cancer
Baseline characteristics by cohort
| Measure |
Enzalutamide
n=42 Participants
Oral therapy with enzalutamide at 160mg (4 capsules) orally once daily (QD).
enzalutamide: oral therapy with enzalutamide at 160mg (4 capsules) orally once daily (QD).
|
|---|---|
|
Age, Continuous
|
59 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: All participants who received treatment and had biochemical recurrence.
Clinical efficacy is measured as time to disease progression defined by biochemical recurrence (BCR). BCR was defined as PSA ≥0.2ng/mL on 2 consecutive lab results or any PSA rise that resulted in subsequent therapy.
Outcome measures
| Measure |
Enzalutamide
n=5 Participants
Oral therapy with enzalutamide at 160mg (4 capsules) orally once daily (QD).
enzalutamide: oral therapy with enzalutamide at 160mg (4 capsules) orally once daily (QD).
|
|---|---|
|
To Evaluate the Clinical Efficacy of Enzalutamide
|
31 months
Interval 13.0 to 40.0
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: All participants that received treatment
The number of patients that experience adverse events related to the study drug. NCI Cancer Clinical Trials Common Toxicity Criteria (version 4.0) will be utilized.
Outcome measures
| Measure |
Enzalutamide
n=42 Participants
Oral therapy with enzalutamide at 160mg (4 capsules) orally once daily (QD).
enzalutamide: oral therapy with enzalutamide at 160mg (4 capsules) orally once daily (QD).
|
|---|---|
|
Safety of Enzalutamide
|
41 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 yearsQuantify mRNA levels of Survivin in CTCs obtained from patients pre- and post-treatment with enzalutamide using the Veridex Cell Search Profile kit.
Outcome measures
Outcome data not reported
Adverse Events
Enzalutamide
Serious events: 2 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Enzalutamide
n=42 participants at risk
Oral therapy with enzalutamide at 160mg (4 capsules) orally once daily (QD).
enzalutamide: oral therapy with enzalutamide at 160mg (4 capsules) orally once daily (QD).
|
|---|---|
|
Nervous system disorders
Abducens nerve disorder
|
2.4%
1/42 • Number of events 1 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Infections and infestations
Bone infection
|
2.4%
1/42 • Number of events 1 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Vascular disorders
Thromboembolic event
|
2.4%
1/42 • Number of events 1 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
Other adverse events
| Measure |
Enzalutamide
n=42 participants at risk
Oral therapy with enzalutamide at 160mg (4 capsules) orally once daily (QD).
enzalutamide: oral therapy with enzalutamide at 160mg (4 capsules) orally once daily (QD).
|
|---|---|
|
Investigations
Alanine aminotransferase increased
|
7.1%
3/42 • Number of events 4 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Investigations
Alkaline phosphatase increased
|
4.8%
2/42 • Number of events 2 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
7.1%
3/42 • Number of events 3 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
35.7%
15/42 • Number of events 15 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Blood and lymphatic system disorders
Anemia
|
21.4%
9/42 • Number of events 10 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
23.8%
10/42 • Number of events 18 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Investigations
Aspartate aminotransferase increased
|
9.5%
4/42 • Number of events 4 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
7/42 • Number of events 9 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Investigations
Blood bilirubin increased
|
4.8%
2/42 • Number of events 3 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Reproductive system and breast disorders
Breast pain
|
38.1%
16/42 • Number of events 18 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Nervous system disorders
Cognitive disturbance
|
9.5%
4/42 • Number of events 4 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Nervous system disorders
Concentration impairment
|
4.8%
2/42 • Number of events 2 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Gastrointestinal disorders
Constipation
|
9.5%
4/42 • Number of events 4 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
3/42 • Number of events 4 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Investigations
Creatinine increased
|
4.8%
2/42 • Number of events 2 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Gastrointestinal disorders
Diarrhea
|
26.2%
11/42 • Number of events 14 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Nervous system disorders
Dizziness
|
14.3%
6/42 • Number of events 7 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Gastrointestinal disorders
Dry mouth
|
7.1%
3/42 • Number of events 3 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.3%
6/42 • Number of events 6 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Nervous system disorders
Dysgeusia
|
7.1%
3/42 • Number of events 3 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Gastrointestinal disorders
Dyspepsia
|
4.8%
2/42 • Number of events 2 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
General disorders
Edema limbs
|
4.8%
2/42 • Number of events 2 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.8%
2/42 • Number of events 3 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Injury, poisoning and procedural complications
Fall
|
4.8%
2/42 • Number of events 2 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
General disorders
Fatigue
|
88.1%
37/42 • Number of events 49 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Gastrointestinal disorders
Flatulence
|
4.8%
2/42 • Number of events 2 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Vascular disorders
Flushing
|
4.8%
2/42 • Number of events 2 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
4.8%
2/42 • Number of events 3 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
14.3%
6/42 • Number of events 6 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Reproductive system and breast disorders
Gynecomastia
|
73.8%
31/42 • Number of events 33 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Nervous system disorders
Headache
|
16.7%
7/42 • Number of events 10 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Vascular disorders
Hot flashes
|
23.8%
10/42 • Number of events 12 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
40.5%
17/42 • Number of events 24 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
23.8%
10/42 • Number of events 18 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Vascular disorders
Hypertension
|
9.5%
4/42 • Number of events 8 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
4.8%
2/42 • Number of events 2 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.1%
3/42 • Number of events 3 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
9.5%
4/42 • Number of events 4 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Psychiatric disorders
Insomnia
|
16.7%
7/42 • Number of events 10 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Investigations
Lymphocyte count decreased
|
21.4%
9/42 • Number of events 15 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Nervous system disorders
Memory impairment
|
9.5%
4/42 • Number of events 5 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.3%
6/42 • Number of events 9 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Gastrointestinal disorders
Nausea
|
19.0%
8/42 • Number of events 14 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
16.7%
7/42 • Number of events 11 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
General disorders
Pain
|
64.3%
27/42 • Number of events 37 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Nervous system disorders
Paresthesia
|
9.5%
4/42 • Number of events 4 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
3/42 • Number of events 3 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
4.8%
2/42 • Number of events 2 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.8%
2/42 • Number of events 2 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Infections and infestations
Rhinitis infective
|
4.8%
2/42 • Number of events 3 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Infections and infestations
Sinusitis
|
4.8%
2/42 • Number of events 2 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Infections and infestations
Skin infection
|
7.1%
3/42 • Number of events 3 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
4.8%
2/42 • Number of events 2 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
7.1%
3/42 • Number of events 4 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Renal and urinary disorders
Urinary frequency
|
4.8%
2/42 • Number of events 3 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Infections and infestations
Urinary tract infection
|
4.8%
2/42 • Number of events 2 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Investigations
Weight gain
|
47.6%
20/42 • Number of events 30 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Investigations
Weight loss
|
26.2%
11/42 • Number of events 13 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
|
Investigations
White blood cell decreased
|
14.3%
6/42 • Number of events 8 • Adverse events were collected while participants were on treatment up to 2 years (24 cycles).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place