Trial Outcomes & Findings for Sorafenib Tosylate and Gene Expression Analysis in Patients Undergoing Surgery For High-Risk Localized Prostate Cancer (NCT NCT00466752)

Last Updated: 2017-11-22

Results Overview

Determined by changes across transcript profiles, by microarray analysis, in pre- versus post-treatment prostate cancer specimens (minimum 50 day time frame between these). Proportion of patients with complete pathologic response.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

Pre- versus post-treatment

Results posted on

2017-11-22

Participant Flow

Subjects were screened and enrolled at a single site in Seattle, Washington, United States.

Five subjects were screened for this study, deemed eligible and enrolled.

Participant milestones

Participant milestones
Measure	48 Hour Drug Stop Point Sorafenib 400mg taken orally twice per day for 41 days prior to radical prostatectomy. Last dose of study drug is the morning dose 2 days prior to surgery.	24 Hour Drug Stop Point Sorafenib 400mg taken orally twice per day for 42 days prior to radical prostatectomy. Last dose of study drug is the morning dose the day prior to surgery.
Overall Study STARTED	5	0
Overall Study COMPLETED	5	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sorafenib Tosylate and Gene Expression Analysis in Patients Undergoing Surgery For High-Risk Localized Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	48 Hour Drug Stop Point n=5 Participants Sorafenib 400mg taken orally twice per day for 41 days prior to radical prostatectomy. Last dose of study drug is the morning dose 2 days prior to surgery.	24 Hour Drug Stop Point Sorafenib 400mg taken orally twice per day for 42 days prior to radical prostatectomy. Last dose of study drug is the morning dose the day prior to surgery.	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=93 Participants	0 Participants n=4 Participants	4 Participants n=27 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Male	5 Participants n=93 Participants	0 Participants n=4 Participants	5 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=93 Participants	0 Participants n=4 Participants	4 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	5 Participants n=93 Participants	0 Participants n=4 Participants	5 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	5 Participants n=93 Participants	—	5 Participants n=27 Participants
Baseline PSA	14.76 ng/mL n=93 Participants	—	14.76 ng/mL n=27 Participants
Gleason Score at Diagnosis	7 units on a scale n=93 Participants	—	7 units on a scale n=27 Participants

PRIMARY outcome

Timeframe: Pre- versus post-treatment

Population: Data not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 of cycles 2 and 3, and day of radical prostatectomy. Each cycle is 2 weeks.

Population: One patient did not have lab samples collected on day of radical prostatectomy.

Proportion of Patients with at least 50% decline in PSA on Day 1 of Cycle 2, Day 1 of Cycle 3, and on day of radical prostatectomy.

Outcome measures

Outcome measures
Measure	48 Hour Drug Stop Point n=5 Participants Sorafenib 400mg taken orally twice per day for 41 days prior to radical prostatectomy. Last dose of study drug is the morning dose 2 days prior to surgery.	24 Hour Drug Stop Point Sorafenib 400mg taken orally twice per day for 42 days prior to radical prostatectomy. Last dose of study drug is the morning dose the day prior to surgery.
Number of Participants With Complete Pathologic Response Day 1 of Cycle 2	0 Participants	—
Number of Participants With Complete Pathologic Response Day 1 of Cycle 3	0 Participants	—
Number of Participants With Complete Pathologic Response Day of Radical Prostatectomy	0 Participants	—

SECONDARY outcome

Timeframe: Day 1 of cycles 2 and 3 and on the day of radical prostatectomy. Each cycle is 2 weeks.

Population: One patient did not have lab samples collected on day of radical prostatectomy.

Proportion of Patients with at least 25% decline in PSA on Day 1 of Cycle 2, Day 1 of Cycle 3, and on day of radical prostatectomy.

Outcome measures

Outcome measures
Measure	48 Hour Drug Stop Point n=5 Participants Sorafenib 400mg taken orally twice per day for 41 days prior to radical prostatectomy. Last dose of study drug is the morning dose 2 days prior to surgery.	24 Hour Drug Stop Point Sorafenib 400mg taken orally twice per day for 42 days prior to radical prostatectomy. Last dose of study drug is the morning dose the day prior to surgery.
Number of Participants With at Least 25% Reduction in PSA Day 1 of Cycle 2	0 Participants	—
Number of Participants With at Least 25% Reduction in PSA Day 1 of Cycle 3	0 Participants	—
Number of Participants With at Least 25% Reduction in PSA Day of Radical Prostatectomy	1 Participants	—

Adverse Events

48 Hour Drug Stop Point

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

24 Hour Drug Stop Point

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Evan Yu

University of Washington / Seattle Cancer Care Alliance

Phone: 206-288-1152

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	48 Hour Drug Stop Point n=5 participants at risk Sorafenib 400mg taken orally twice per day for 41 days prior to radical prostatectomy. Last dose of study drug is the morning dose 2 days prior to surgery.	24 Hour Drug Stop Point Sorafenib 400mg taken orally twice per day for 42 days prior to radical prostatectomy. Last dose of study drug is the morning dose the day prior to surgery.
Ear and labyrinth disorders Tinnitus	20.0% 1/5 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 113 If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.	— 0/0 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 113 If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
Gastrointestinal disorders Constipation	20.0% 1/5 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 113 If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.	— 0/0 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 113 If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
Gastrointestinal disorders Diarrhea	40.0% 2/5 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 113 If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.	— 0/0 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 113 If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
General disorders pain, gastrointestinal, oral cavity, esophagus	20.0% 1/5 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 113 If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.	— 0/0 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 113 If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
General disorders pain, renal/genitourinary	20.0% 1/5 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 113 If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.	— 0/0 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 113 If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
General disorders Fatigue	60.0% 3/5 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 113 If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.	— 0/0 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 113 If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
General disorders Weight loss	20.0% 1/5 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 113 If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.	— 0/0 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 113 If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
Hepatobiliary disorders Pancreatitis	20.0% 1/5 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 113 If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.	— 0/0 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 113 If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
Metabolism and nutrition disorders Transaminitis	20.0% 1/5 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 113 If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.	— 0/0 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 113 If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
Musculoskeletal and connective tissue disorders pain, musculoskeletal, extremity-limb	20.0% 1/5 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 113 If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.	— 0/0 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 113 If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
Nervous system disorders Tingling feet and scalp	20.0% 1/5 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 113 If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.	— 0/0 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 113 If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
Renal and urinary disorders Urinary retention	20.0% 1/5 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 113 If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.	— 0/0 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 113 If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
Renal and urinary disorders urination frequency and urgency	20.0% 1/5 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 113 If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.	— 0/0 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 113 If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
Reproductive system and breast disorders Gynecomastia	20.0% 1/5 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 113 If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.	— 0/0 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 113 If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
Respiratory, thoracic and mediastinal disorders voice changes/dysarthria	80.0% 4/5 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 113 If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.	— 0/0 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 113 If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
Skin and subcutaneous tissue disorders Alopecia	40.0% 2/5 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 113 If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.	— 0/0 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 113 If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
Skin and subcutaneous tissue disorders Dry skin	20.0% 1/5 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 113 If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.	— 0/0 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 113 If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
Skin and subcutaneous tissue disorders Hand-foot syndrome	40.0% 2/5 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 113 If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.	— 0/0 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 113 If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
Skin and subcutaneous tissue disorders Pruritis	40.0% 2/5 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 113 If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.	— 0/0 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 113 If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
Skin and subcutaneous tissue disorders Rash	40.0% 2/5 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 113 If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.	— 0/0 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 113 If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
Vascular disorders Hypertension	80.0% 4/5 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 113 If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.	— 0/0 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 113 If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.