Trial Outcomes & Findings for A Study of VEGF Tyrosine Kinase Inhibitor (Pazopanib) in Men With High-Risk Prostate Cancer Followed by Radical Prostatectomy and Pelvic Lymph Node Dissection (NCT NCT01832259)

Last Updated: 2018-12-12

Results Overview

Patients with high-risk, localized prostate cancer were treated with 28 days of Pazopanib or placebo, after which they underwent radical prostatectomy. During prostatectomy, benign pelvic lymph node tissue was collected and subsequently analyzed for the average number of VEGFR1-positive clusters in 8 distinct 40x microscopic fields as an indicator of pre-metastatic niche formation.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

1 month

Results posted on

2018-12-12

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Arm Participants receiving placebo Placebo: Placebo tablet orally, daily for 28 days prior to radical prostatectomy.	Pazopanib Arm Participants receiving Pazopanib Pazopanib: Pazopanib, 800 mg, orally daily for 28 days prior to radical prostatectomy.
Overall Study STARTED	15	15
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of VEGF Tyrosine Kinase Inhibitor (Pazopanib) in Men With High-Risk Prostate Cancer Followed by Radical Prostatectomy and Pelvic Lymph Node Dissection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Arm n=15 Participants Participants receiving placebo Placebo: Placebo tablet orally, daily for 28 days prior to radical prostatectomy.	Pazopanib Arm n=15 Participants Participants receiving Pazopanib Pazopanib: Pazopanib, 800 mg, orally daily for 28 days prior to radical prostatectomy.	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Age, Continuous	63.33 years STANDARD_DEVIATION 4.71 • n=5 Participants	64.13 years STANDARD_DEVIATION 6.26 • n=7 Participants	63.73 years STANDARD_DEVIATION 5.56 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month

Population: The tissue of one patient on the Pazopanib arm and two patients on the Placebo arm was not able to be analyzed. Another patient on the Pazopanib arm had surgery delayed by a few weeks following stopping study medication and was determined to be unevaluable, resulting in 13 patients analyzed on each arm.

Outcome measures

Outcome measures
Measure	Placebo Arm n=13 Participants Participants receiving placebo Placebo: Placebo tablet orally, daily for 28 days prior to radical prostatectomy.	Pazopanib Arm n=13 Participants Participants receiving Pazopanib Pazopanib: Pazopanib, 800 mg, orally daily for 28 days prior to radical prostatectomy.
Number of Vascular Endothelial Growth Factor Receptor 1 (VEGFR1)-Positive Clusters	0.251560 VEGFR1+ clusters per hpf Standard Deviation 0.093458902	0.269518 VEGFR1+ clusters per hpf Standard Deviation 0.120773334

SECONDARY outcome

Timeframe: From first dose of study treatment to one month post-prostatectomy (approximately 2 months)

Adverse events were assessed using the Common Terminology for Adverse Events (CTCAE) version 4. Each event was assigned a grade (1-5), with lower grades indicating milder events. All adverse events were recorded, regardless of attribution to study treatment. For a full listing of Adverse Events, please see the Adverse Events section of the Results for this study.

Outcome measures

Outcome measures
Measure	Placebo Arm n=15 Participants Participants receiving placebo Placebo: Placebo tablet orally, daily for 28 days prior to radical prostatectomy.	Pazopanib Arm n=15 Participants Participants receiving Pazopanib Pazopanib: Pazopanib, 800 mg, orally daily for 28 days prior to radical prostatectomy.
Participants Experiencing Adverse Events Participants experiencing Grade 1-2 Adverse Events	15 Participants	15 Participants
Participants Experiencing Adverse Events Participants experiencing Grade 3-4 Adverse Events	0 Participants	4 Participants

SECONDARY outcome

Timeframe: 2 years

Population: Two patients on the Pazopanib arm were not evaluable, one due to prostatectomy not being completed, and one due to prostatectomy being delayed outside of protocol windows.

Following prostatectomy, patients' Prostate Specific Antigen (PSA) lab values were collected for up to two years. Biochemical recurrence was defined as the first PSA lab value of greater than or equal to 0.2 ng/mL following prostatectomy. Biochemical recurrence progression free survival rate was defined as the percent chance of 1 year survival with no biochemical recurrence.

Outcome measures

Outcome measures
Measure	Placebo Arm n=15 Participants Participants receiving placebo Placebo: Placebo tablet orally, daily for 28 days prior to radical prostatectomy.	Pazopanib Arm n=13 Participants Participants receiving Pazopanib Pazopanib: Pazopanib, 800 mg, orally daily for 28 days prior to radical prostatectomy.
Biochemical Recurrence Progression Free Survival Rate	73.3 percent chance of survival Interval 54.0 to 99.5	92.3 percent chance of survival Interval 78.9 to 100.0

Adverse Events

Placebo Arm

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Pazopanib Arm

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Josiah Lyn Hawks

Huntsman Cancer Institute / University of Utah

Phone: 801-585-0601

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	Placebo Arm n=15 participants at risk Participants receiving placebo Placebo: Placebo tablet orally, daily for 28 days prior to radical prostatectomy.	Pazopanib Arm n=15 participants at risk Participants receiving Pazopanib Pazopanib: Pazopanib, 800 mg, orally daily for 28 days prior to radical prostatectomy.
Gastrointestinal disorders Abdominal pain	26.7% 4/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.	13.3% 2/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
Psychiatric disorders Agitation	6.7% 1/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.	0.00% 0/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
Investigations Alanine aminotransferase increased	0.00% 0/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.	26.7% 4/15 • Number of events 5 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.	6.7% 1/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
Blood and lymphatic system disorders Anemia	13.3% 2/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.	0.00% 0/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
Metabolism and nutrition disorders Anorexia	6.7% 1/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.	13.3% 2/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
Psychiatric disorders Anxiety	6.7% 1/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.	0.00% 0/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.	13.3% 2/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
Investigations Aspartate aminotransferase increased	0.00% 0/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.	26.7% 4/15 • Number of events 5 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
Musculoskeletal and connective tissue disorders Back pain	6.7% 1/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.	6.7% 1/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
Renal and urinary disorders Bladder spasm	13.3% 2/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.	0.00% 0/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
Gastrointestinal disorders Bloating	6.7% 1/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.	0.00% 0/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
Investigations Blood bilirubin increased	6.7% 1/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.	6.7% 1/15 • Number of events 2 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
Injury, poisoning and procedural complications Bruising	6.7% 1/15 • Number of events 2 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.	6.7% 1/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
Injury, poisoning and procedural complications Burn	6.7% 1/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.	0.00% 0/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
Cardiac disorders Irregular heartbeat	6.7% 1/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.	0.00% 0/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
General disorders Chills	6.7% 1/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.	0.00% 0/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
Gastrointestinal disorders Constipation	20.0% 3/15 • Number of events 4 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.	0.00% 0/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
Respiratory, thoracic and mediastinal disorders Cough	6.7% 1/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.	6.7% 1/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
Investigations Creatinine increased	6.7% 1/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.	0.00% 0/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
Metabolism and nutrition disorders Dehydration	0.00% 0/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.	6.7% 1/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
Psychiatric disorders Depression	6.7% 1/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.	6.7% 1/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
Gastrointestinal disorders Diarrhea	33.3% 5/15 • Number of events 6 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.	40.0% 6/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
Nervous system disorders Dizziness	13.3% 2/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.	20.0% 3/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
Gastrointestinal disorders Dry mouth	6.7% 1/15 • Number of events 2 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.	6.7% 1/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.	6.7% 1/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
Nervous system disorders Dysgeusia	13.3% 2/15 • Number of events 3 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.	13.3% 2/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
Gastrointestinal disorders Dyspepsia	13.3% 2/15 • Number of events 3 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.	6.7% 1/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
Respiratory, thoracic and mediastinal disorders Dyspnea	6.7% 1/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.	0.00% 0/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.	13.3% 2/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
Reproductive system and breast disorders Erectile dysfunction	13.3% 2/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.	0.00% 0/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
Eye disorders Eye disorders - Other	0.00% 0/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.	20.0% 3/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
General disorders Fatigue	40.0% 6/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.	60.0% 9/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
General disorders Fever	6.7% 1/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.	0.00% 0/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
Musculoskeletal and connective tissue disorders Flank pain	6.7% 1/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.	6.7% 1/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
Gastrointestinal disorders Flatulence	6.7% 1/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.	0.00% 0/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
General disorders Flu like symptoms	20.0% 3/15 • Number of events 4 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.	6.7% 1/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
Vascular disorders Flushing	0.00% 0/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.	6.7% 1/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.	13.3% 2/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
Gastrointestinal disorders Loose stool	6.7% 1/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.	0.00% 0/15 • Adverse events were collected for approximately 2 months (from first dose of study medication to 1 month post-prostatectomy). The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.