Trial Outcomes & Findings for Enzalutamide & Dutasteride/Finasteride as 1st Line Treatment for Patients =/> 65 Years Old With Prostate Cancer. (NCT NCT02213107)

NCT ID: NCT02213107

Last Updated: 2024-11-13

Results Overview

Percentage of participants with progression-free survival at 3 years. PSA disease progression is defined as an increase in the PSA that is \>=25% and \>=2 ng/ml above the nadir PSA value.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 43 participants
• Primary outcome timeframe: 3 years.
• Results posted on: 2024-11-13

Participant Flow

This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on considering subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as a single treatment group. As a result, all analyses for study outcome were performed by including subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.

Participant milestones

Measure	Enzalutamide and Dutasteride or Finasteride Use of either 1. Enzalutamide and dutasteride or 2. Enzalutamide and finasteride. Enzalutamide and Dutasteride or finasteride: Use of either two oral drugs together 1. Enzalutamide by mouth daily and dutasteride by mouth daily or 2. Enzalutamide by mouth daily and finasteride by mouth daily
Overall Study STARTED	43
Overall Study COMPLETED	43
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Enzalutamide & Dutasteride/Finasteride as 1st Line Treatment for Patients =/> 65 Years Old With Prostate Cancer.

Baseline characteristics by cohort

Measure	Enzalutamide and Dutasteride or Finasteride n=43 Participants Use of either 1. Enzalutamide and dutasteride or 2. Enzalutamide and finasteride. Enzalutamide and Dutasteride or finasteride: Use of either two oral drugs together 1. Enzalutamide by mouth daily and dutasteride by mouth daily or 2. Enzalutamide by mouth daily and finasteride by mouth daily
Age, Continuous	78 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	41 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	43 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 years.

Population: This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on considering subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as a single treatment group. As a result, primary study outcome analyses were performed by including subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.

Percentage of participants with progression-free survival at 3 years. PSA disease progression is defined as an increase in the PSA that is >=25% and >=2 ng/ml above the nadir PSA value.

Outcome measures

Measure	Enzalutamide and Dutasteride or Finasteride n=43 Participants Use of either 1. Enzalutamide and dutasteride or 2. Enzalutamide and finasteride. Enzalutamide and Dutasteride or finasteride: Use of either two oral drugs together 1. Enzalutamide by mouth daily and dutasteride by mouth daily or 2. Enzalutamide by mouth daily and finasteride by mouth daily
Prostate Specific Antigen (PSA) Progression Free Survival	85.3 percentage of participants Interval 70.0 to 93.1

SECONDARY outcome

Timeframe: up to approximately 8 years

Population: This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for this outcome included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group. One patient has missing data at 8 years

Lowest PSA value achieved.

Outcome measures

Measure	Enzalutamide and Dutasteride or Finasteride n=42 Participants Use of either 1. Enzalutamide and dutasteride or 2. Enzalutamide and finasteride. Enzalutamide and Dutasteride or finasteride: Use of either two oral drugs together 1. Enzalutamide by mouth daily and dutasteride by mouth daily or 2. Enzalutamide by mouth daily and finasteride by mouth daily
Absolute PSA Response	0.02 ng/dl Interval 0.0 to 2.75

SECONDARY outcome

Timeframe: up to approximately 8 years

Population: This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for this outcome included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group. One subject has missing data at 8 years

Time (months) to achieve the lowest PSA value compared to baseline PSA level

Outcome measures

Measure	Enzalutamide and Dutasteride or Finasteride n=42 Participants Use of either 1. Enzalutamide and dutasteride or 2. Enzalutamide and finasteride. Enzalutamide and Dutasteride or finasteride: Use of either two oral drugs together 1. Enzalutamide by mouth daily and dutasteride by mouth daily or 2. Enzalutamide by mouth daily and finasteride by mouth daily
Time to PSA Nadir	8.05 months Interval 1.38 to 78.3

SECONDARY outcome

Timeframe: up to approximately 8 years

Population: This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for this outcome included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.

Adverse events will be defined according to CTCAE version 4.0.

Outcome measures

Measure	Enzalutamide and Dutasteride or Finasteride n=43 Participants Use of either 1. Enzalutamide and dutasteride or 2. Enzalutamide and finasteride. Enzalutamide and Dutasteride or finasteride: Use of either two oral drugs together 1. Enzalutamide by mouth daily and dutasteride by mouth daily or 2. Enzalutamide by mouth daily and finasteride by mouth daily
Number of Participants Who Experience a Treatment-related Adverse Events.	43 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline to week 103

Change in bone density at week 103 compared to baseline bone density, measured using DEXA study.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline to week 61

Change in quality of life score at follow up compared to baseline score, using FACT-P survey. The FACT-P survey is a 39 item questionnaire with a score that ranges from 0-156 with higher scores indicating better quality of life.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 1 to approximately 36 months

Change in comprehensive geriatric assessment domains at follow up compared to baseline evaluation.

Outcome measures

Outcome data not reported

Adverse Events

Use of Enzalutamide and Dutasteride or Finasteride

Serious events: 26 serious events

Other events: 43 other events

Deaths: 5 deaths

Serious adverse events

Measure	Use of Enzalutamide and Dutasteride or Finasteride n=43 participants at risk Use of either 1. Enzalutamide and dutasteride or 2. Enzalutamide and finasteride.
Gastrointestinal disorders Abdominal pain	2.3% 1/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Blood and lymphatic system disorders Anemia	2.3% 1/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Cardiac disorders Aortic valve disease	2.3% 1/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Cardiac disorders Chest pain, cardiac	2.3% 1/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Injury, poisoning and procedural complications Fall	2.3% 1/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Infections and infestations Infection and Infestation, Other	2.3% 1/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Gastrointestinal disorders gastroesophageal reflux disease	2.3% 1/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Renal and urinary disorders Acute kidney injury	2.3% 1/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Cardiac disorders Atrial fibrilation	2.3% 1/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Gastrointestinal disorders Colitis	2.3% 1/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Gastrointestinal disorders Colonic obstruction	2.3% 1/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Nervous system disorders Dysphasia	2.3% 1/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Nervous system disorders Facial muscle weakness	2.3% 1/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Respiratory, thoracic and mediastinal disorders Dyspnea	2.3% 1/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Renal and urinary disorders Hematuria	2.3% 1/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Blood and lymphatic system disorders Hemorrhage	2.3% 1/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Infections and infestations Lung infection	2.3% 1/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Infections and infestations Lyme disease	2.3% 1/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Cardiac disorders Myocardial infarction	4.7% 2/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Gastrointestinal disorders Obstruction	2.3% 1/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Nervous system disorders Presyncope	2.3% 1/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Infections and infestations Sepsis	4.7% 2/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Urothelial carcinoma in-situ	2.3% 1/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Infections and infestations Covid 19	2.3% 1/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Gastrointestinal disorders constipation	2.3% 1/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.

Other adverse events

Measure	Use of Enzalutamide and Dutasteride or Finasteride n=43 participants at risk Use of either 1. Enzalutamide and dutasteride or 2. Enzalutamide and finasteride.
Nervous system disorders Akathisia	7.0% 3/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Skin and subcutaneous tissue disorders Alopecia	14.0% 6/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Blood and lymphatic system disorders Anemia	23.3% 10/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Metabolism and nutrition disorders Anorexia	25.6% 11/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Immune system disorders Athralgia	27.9% 12/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Reproductive system and breast disorders Breast pain	11.6% 5/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Gastrointestinal disorders Constipation	34.9% 15/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Gastrointestinal disorders Diarrhea	32.6% 14/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Nervous system disorders Dizziness	34.9% 15/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Nervous system disorders Dysgeusia	20.9% 9/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Injury, poisoning and procedural complications Fall	34.9% 15/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
General disorders Fatigue	88.4% 38/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	14.0% 6/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Reproductive system and breast disorders Gynecomastia	72.1% 31/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Vascular disorders Hot flashes	41.9% 18/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Vascular disorders Hypertension	39.5% 17/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Nervous system disorders Memory impairment	18.6% 8/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Musculoskeletal and connective tissue disorders Myalgia	14.0% 6/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Gastrointestinal disorders Nausea	25.6% 11/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Musculoskeletal and connective tissue disorders Osteoporosis	18.6% 8/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Nervous system disorders Paresthesia	20.9% 9/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Investigations Weight loss	11.6% 5/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Gastrointestinal disorders Abdominal Pain	14.0% 6/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Musculoskeletal and connective tissue disorders Arthritis	25.6% 11/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Investigations AST increased	9.3% 4/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Musculoskeletal and connective tissue disorders Back pain	20.9% 9/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Blood and lymphatic system disorders Blood and Lymphatic Disorders, Other	9.3% 4/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Eye disorders Blurred Vision	9.3% 4/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Cardiac disorders Cardiac disorder, other	7.0% 3/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Eye disorders Cataract	9.3% 4/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Cardiac disorders Chest pain, cardiac	4.7% 2/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Respiratory, thoracic and mediastinal disorders Cough	30.2% 13/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Investigations Creatinine increase	18.6% 8/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Renal and urinary disorders Cystitis noninfective	7.0% 3/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Skin and subcutaneous tissue disorders Dry Skin	7.0% 3/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Gastrointestinal disorders Dyspepsia	11.6% 5/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Gastrointestinal disorders Dysphagia	9.3% 4/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Respiratory, thoracic and mediastinal disorders Dyspnea	37.2% 16/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
General disorders Edema of limbs	30.2% 13/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Respiratory, thoracic and mediastinal disorders Epistaxis	7.0% 3/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Reproductive system and breast disorders Erectile dysfunction	7.0% 3/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Eye disorders Eye disorders, Other	16.3% 7/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Eye disorders Floaters	7.0% 3/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Injury, poisoning and procedural complications Fracture	7.0% 3/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Gastrointestinal disorders Gastroesophageal reflux disease	4.7% 2/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Gastrointestinal disorders Gastrointestinal disorders, other	14.0% 6/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
General disorders General disorders	14.0% 6/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Nervous system disorders Headache	16.3% 7/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Ear and labyrinth disorders Hearing impaired	7.0% 3/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Renal and urinary disorders Hematuria	18.6% 8/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Metabolism and nutrition disorders Hyperglycemia	7.0% 3/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Metabolism and nutrition disorders Hyperkalemia	14.0% 6/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Metabolism and nutrition disorders Hypoglycemia	7.0% 3/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Vascular disorders Hypotension	14.0% 6/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Infections and infestations Infection and Infestation, Other	9.3% 4/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Injury, poisoning and procedural complications Injury, poisoning, or procedural complications, other	9.3% 4/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Psychiatric disorders Insomnia	14.0% 6/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Investigations Lymphocyte Count Decreased	11.6% 5/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder, other	14.0% 6/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Respiratory, thoracic and mediastinal disorders Nasal congestion	11.6% 5/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant, and unspecified	14.0% 6/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Investigations Neutrophil count decreased	7.0% 3/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
General disorders Non-cardiac chest pain	20.9% 9/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
General disorders Pain	20.9% 9/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Musculoskeletal and connective tissue disorders Pain in extremity	25.6% 11/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Nervous system disorders Peripheral sensory neuropathy	9.3% 4/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Psychiatric disorders Psychiatric disorder, other	7.0% 3/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Skin and subcutaneous tissue disorders Rash, maculo-papular	16.3% 7/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Renal and urinary disorders Renal and urinary disorder	11.6% 5/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Reproductive system and breast disorders Reproductive system and breast disorders, others	9.3% 4/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic, and mediastinal disorders, other	14.0% 6/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Skin and subcutaneous tissue disorders Other Skin and Subcutaneous Tissue Disorders	20.9% 9/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Infections and infestations Upper respiratory infection	14.0% 6/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Renal and urinary disorders Urinary frequency	14.0% 6/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Renal and urinary disorders Urinary incontinence	18.6% 8/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Infections and infestations Urinary tract infection	9.3% 4/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Renal and urinary disorders Urinary urgency	9.3% 4/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Investigations Weight gain	11.6% 5/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Investigations White blood cell decreased	9.3% 4/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.
Cardiac disorders Aortic valve disease	4.7% 2/43 • up to approximately 8 years This is a single arm study that evaluates the effect of enzalutamide and a 5-alpha reductase inhibitor, with either dutasteride or finasteride. The sample size and power calculations were based on including subjects using enzalutamide and a 5-alpha reductase inhibitor with either dutasteride or finasteride as one treatment group. The analyses for adverse events included subjects using enzalutamide and a 5-alpha reductase inhibitor as one treatment group.

Additional Information

Chunkit Fung, MD

University of Rochester

Phone: 585 - 275 - 5823

Email: chunkit_fung@urmc.rochester.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place