Trial Outcomes & Findings for EXTEND Exercise Trial (NCT NCT02256111)

NCT ID: NCT02256111

Last Updated: 2019-04-18

Results Overview

Mean change in peak oxygen uptake (VO2peak) from week 1 to week 17 in the usual care and exercise training groups

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

26 participants

Primary outcome timeframe

From week 1 to week 17

Results posted on

2019-04-18

Participant Flow

Participant milestones

Participant milestones
Measure	ENZ+ADT+Usual Care The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training. Enzalutamide Androgen deprivation therapy	ENZ+ADT+Exercise The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training. Enzalutamide Androgen deprivation therapy Supervised exercise training
Overall Study STARTED	13	13
Overall Study COMPLETED	13	13
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

EXTEND Exercise Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ENZ+ADT+Usual Care n=13 Participants The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training. Enzalutamide Androgen deprivation therapy	ENZ+ADT+Exercise n=13 Participants The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training. Enzalutamide Androgen deprivation therapy Supervised exercise training	Total n=26 Participants Total of all reporting groups
Age, Continuous	64.37 years STANDARD_DEVIATION 8.31 • n=5 Participants	65.66 years STANDARD_DEVIATION 8.11 • n=7 Participants	65.01 years STANDARD_DEVIATION 8.07 • 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	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants	13 Participants n=7 Participants	26 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	1 Participants n=5 Participants	0 Participants n=7 Participants	1 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	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	10 Participants n=7 Participants	20 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	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: From week 1 to week 17

Mean change in peak oxygen uptake (VO2peak) from week 1 to week 17 in the usual care and exercise training groups

Outcome measures

Outcome measures
Measure	ENZ+ADT+Exercise n=13 Participants The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training. Enzalutamide Androgen deprivation therapy Supervised exercise training	ENZ+ADT+Usual Care n=13 Participants The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training. Enzalutamide Androgen deprivation therapy
Change in VO2peak in Usual Care Versus Exercise Training Arms	-0.92 mL/kg/min Standard Deviation 2.4	-3.23 mL/kg/min Standard Deviation 5.02

SECONDARY outcome

Timeframe: Baseline to 17 weeks

Population: One patient in the usual care arm did not complete the test at week 17

Mean change in number of seconds to perform the chair-stand test between baseline and week 17. This test measures the time taken to complete 5 repetitions of the sit-to-stand maneuver from a chair without an arm rest at 43 cm in height and 47.5 cm in depth. This test provides an indicator of functional performance of lower body strength; quicker times indicate greater strength

Outcome measures

Outcome measures
Measure	ENZ+ADT+Exercise n=13 Participants The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training. Enzalutamide Androgen deprivation therapy Supervised exercise training	ENZ+ADT+Usual Care n=12 Participants The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training. Enzalutamide Androgen deprivation therapy
17-week Change in Functional Capacity as Measured by Chair-stand Test	-0.78 seconds Standard Deviation 1.7	-1.08 seconds Standard Deviation 2.29

SECONDARY outcome

Timeframe: Baseline to 17 weeks

Population: 1 patient out of 13 did not complete the 1-RM at baseline or week 17 in the usual care arm, and another did not complete the 70% 1-RM at week 17 out of 12

Mean change in upper and lower extremity maximal muscular strength as measured by the voluntary one-repetition max (1-RM) and muscular endurance as measured by 70% of 1-RM between week 17 and baseline

Outcome measures

Outcome measures
Measure	ENZ+ADT+Exercise n=13 Participants The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training. Enzalutamide Androgen deprivation therapy Supervised exercise training	ENZ+ADT+Usual Care n=12 Participants The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training. Enzalutamide Androgen deprivation therapy
17-week Change in Upper and Lower Extremity Maximal Muscular Strength Change in Leg Press 1-RM	107.8 pounds Standard Deviation 105.75	6.67 pounds Standard Deviation 83.99
17-week Change in Upper and Lower Extremity Maximal Muscular Strength Change in Leg Press 70% 1-RM	74.92 pounds Standard Deviation 74.05	10 pounds Standard Deviation 57.4
17-week Change in Upper and Lower Extremity Maximal Muscular Strength Change in Chest Press 1-RM	24.31 pounds Standard Deviation 24.99	5.08 pounds Standard Deviation 24.96
17-week Change in Upper and Lower Extremity Maximal Muscular Strength Change in Chest Press 70% 1-RM	17 pounds Standard Deviation 17.32	6.73 pounds Standard Deviation 13.93
17-week Change in Upper and Lower Extremity Maximal Muscular Strength Change in Seated Row 1-RM	14.85 pounds Standard Deviation 23.39	2.25 pounds Standard Deviation 20.86
17-week Change in Upper and Lower Extremity Maximal Muscular Strength Change in Seated Row 70% 1-RM	10.46 pounds Standard Deviation 16.47	-0.27 pounds Standard Deviation 18.29

SECONDARY outcome

Timeframe: Baseline to 17 weeks

Population: Only 10 in the usual care and 8 in the exercise arm patients had glucose measurements at both baseline and week 17.

Mean change in fasting serum glucose between week 17 and baseline.

Outcome measures

Outcome measures
Measure	ENZ+ADT+Exercise n=8 Participants The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training. Enzalutamide Androgen deprivation therapy Supervised exercise training	ENZ+ADT+Usual Care n=10 Participants The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training. Enzalutamide Androgen deprivation therapy
Effects on Serum Glucose	-1 mg/dL Standard Deviation 5.55	5.3 mg/dL Standard Deviation 16.22

SECONDARY outcome

Timeframe: Baseline to 17 weeks

Mean change in PROs aggregate score between week 17 and baseline. PROs include the FACT-Prostate (FACT-P, range 0 to 104), FACIT-Fatigue (FACIT-F, range 0 to 52), and the Godin Leisure Questionnaire. Higher scores indicate better quality of life.

Outcome measures

Outcome measures
Measure	ENZ+ADT+Exercise n=13 Participants The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training. Enzalutamide Androgen deprivation therapy Supervised exercise training	ENZ+ADT+Usual Care n=13 Participants The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training. Enzalutamide Androgen deprivation therapy
Change in the Effect on Patient Reported Outcomes (PROs) of Interest Over Time FACIT-Fatigue score	-5 score on a scale Standard Deviation 4.88	-9.15 score on a scale Standard Deviation 11.25
Change in the Effect on Patient Reported Outcomes (PROs) of Interest Over Time FACT-Prostate Trial Outcome Index	-5.38 score on a scale Standard Deviation 9.01	-11.61 score on a scale Standard Deviation 14.39
Change in the Effect on Patient Reported Outcomes (PROs) of Interest Over Time Godin Leisure score	9.33 score on a scale Standard Deviation 17.55	4.67 score on a scale Standard Deviation 26.2

SECONDARY outcome

Timeframe: 29 months from study initiation

Population: This overall number of participants analyzed reflects the total number of individuals approached for this study.

Eligibility rate is defined as the number of subjects found to be eligible divided by the number approached for the study. Note that ineligible subjects are not randomized. This is reported as a percent.

Outcome measures

Outcome measures
Measure	ENZ+ADT+Exercise The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training. Enzalutamide Androgen deprivation therapy Supervised exercise training	ENZ+ADT+Usual Care n=30 Participants The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training. Enzalutamide Androgen deprivation therapy
Eligibility Rate	—	87 percentage of participants

SECONDARY outcome

Timeframe: 29 months from study initiation

Acceptance rate is defined as the number of patients agreeing to participate divided by total number randomized. This is reported as a percent.

Outcome measures

Outcome measures
Measure	ENZ+ADT+Exercise n=13 Participants The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training. Enzalutamide Androgen deprivation therapy Supervised exercise training	ENZ+ADT+Usual Care n=13 Participants The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training. Enzalutamide Androgen deprivation therapy
Acceptance Rate	100 percentage of participants	100 percentage of participants

SECONDARY outcome

Timeframe: 48 days

Adherence rate is defined as the percentage of days that each patient fulfilled the assigned exercise prescription of the 48 days. The median percentage is reported.

Outcome measures

Outcome measures
Measure	ENZ+ADT+Exercise n=13 Participants The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training. Enzalutamide Androgen deprivation therapy Supervised exercise training	ENZ+ADT+Usual Care n=13 Participants The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training. Enzalutamide Androgen deprivation therapy
Adherence Rate	95.8 percentage of days Interval 81.2 to 100.0	NA percentage of days Adherence rate does not apply to the usual care arm.

SECONDARY outcome

Timeframe: 16 weeks

Attrition rate is defined as the percent of subjects who complete the 16 week exercise training program. This outcome applies only to the exercise arm.

Outcome measures

Outcome measures
Measure	ENZ+ADT+Exercise n=13 Participants The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training. Enzalutamide Androgen deprivation therapy Supervised exercise training	ENZ+ADT+Usual Care n=13 Participants The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training. Enzalutamide Androgen deprivation therapy
Attrition Rate	100 percentage of participants	NA percentage of participants Attrition rate does not apply to the usual care arm.

SECONDARY outcome

Timeframe: Baseline to 17 weeks

Population: One patient in the usual care arm did not complete the test at week 17

Mean change in number of seconds to complete the timed up and go test between week 17 and baseline. This test requires patients to stand up from a chair with armrests, walk 3m, turn around, return to the chair, and sit down

Outcome measures

Outcome measures
Measure	ENZ+ADT+Exercise n=13 Participants The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training. Enzalutamide Androgen deprivation therapy Supervised exercise training	ENZ+ADT+Usual Care n=12 Participants The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training. Enzalutamide Androgen deprivation therapy
17-week Change in Functional Capacity as Measured by Time Up and Go Test	0.08 seconds Standard Deviation 0.95	0.33 seconds Standard Deviation 1.07

SECONDARY outcome

Timeframe: Baseline to 17 weeks

Population: Two patients in the usual care arm did not complete the test at both baseline and week 17

Mean change in distance covered during the six minute walk test between week 17 and baseline. This test requires patients to cover the longest distance possible in six minutes under the supervision of an exercise physiologist or designee.

Outcome measures

Outcome measures
Measure	ENZ+ADT+Exercise n=13 Participants The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training. Enzalutamide Androgen deprivation therapy Supervised exercise training	ENZ+ADT+Usual Care n=11 Participants The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training. Enzalutamide Androgen deprivation therapy
17-week Change in Functional Capacity as Measured by Six Minute Walk Test	42 meters Standard Deviation 60.26	-32.02 meters Standard Deviation 58.47

SECONDARY outcome

Timeframe: Baseline to 17 weeks

Population: Only 10 in the usual care and 8 in the exercise arm patients had cross-sectional area measurements performed at both measurement time points.

Mean change in muscle cross sectional area of the dominant quadricep, hamstring, and total mid-thigh between week 17 and baseline. Cross-sectional area was measured using magnetic resonance imaging with a 3.0T-scanner.

Outcome measures

Outcome measures
Measure	ENZ+ADT+Exercise n=8 Participants The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training. Enzalutamide Androgen deprivation therapy Supervised exercise training	ENZ+ADT+Usual Care n=10 Participants The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training. Enzalutamide Androgen deprivation therapy
17-week Change in Muscle Cross-sectional Area (CSA) Change in quadricep CSA	-4.03 cm^2 Standard Deviation 3.24	-4.84 cm^2 Standard Deviation 4.03
17-week Change in Muscle Cross-sectional Area (CSA) Change in hamstring CSA	-5.09 cm^2 Standard Deviation 4.04	-4.8 cm^2 Standard Deviation 5.32
17-week Change in Muscle Cross-sectional Area (CSA) Change in total mid-thigh CSA	-9.12 cm^2 Standard Deviation 7.01	-9.43 cm^2 Standard Deviation 6.12

SECONDARY outcome

Timeframe: Baseline to 17 weeks

Population: Only 10 in the usual care and 8 in the exercise arm patients had insulin measurements at both baseline and week 17.

Mean change in fasting serum insulin between week 17 and baseline.

Outcome measures

Outcome measures
Measure	ENZ+ADT+Exercise n=8 Participants The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training. Enzalutamide Androgen deprivation therapy Supervised exercise training	ENZ+ADT+Usual Care n=10 Participants The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training. Enzalutamide Androgen deprivation therapy
Effects on Serum Insulin	0 u[iU]/mL Standard Deviation 11.05	2.61 u[iU]/mL Standard Deviation 5.06

SECONDARY outcome

Timeframe: Baseline to 17 weeks

Population: Only 10 in the usual care and 8 in the exercise arm patients had Hgb measurements at both baseline and week 17.

Mean change in blood hemoglobin (Hgb) A1C between week 17 and baseline.

Outcome measures

Outcome measures
Measure	ENZ+ADT+Exercise n=8 Participants The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training. Enzalutamide Androgen deprivation therapy Supervised exercise training	ENZ+ADT+Usual Care n=10 Participants The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training. Enzalutamide Androgen deprivation therapy
Effects on Blood Hemoglobin (Hgb)	1.15 percentage of glycated hemoglobin Standard Deviation 2.81	-0.04 percentage of glycated hemoglobin Standard Deviation 0.39

SECONDARY outcome

Timeframe: Baseline to 17 weeks

Mean change in lean body mass and fat body mass between week 17 and baseline as measured by a DEXA Scan.

Outcome measures

Outcome measures
Measure	ENZ+ADT+Exercise n=13 Participants The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training. Enzalutamide Androgen deprivation therapy Supervised exercise training	ENZ+ADT+Usual Care n=13 Participants The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training. Enzalutamide Androgen deprivation therapy
Effects on Body Composition Change in lean body mass	-2094.42 g Standard Deviation 2407.27	-3087.92 g Standard Deviation 3799.02
Effects on Body Composition Change in fat body mass	-121.45 g Standard Deviation 2435.41	2949.36 g Standard Deviation 3944.65

Adverse Events

ENZ+ADT+Usual Care

Serious events: 4 serious events

Other events: 13 other events

Deaths: 0 deaths

ENZ+ADT+Exercise

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ENZ+ADT+Usual Care n=13 participants at risk The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training. Enzalutamide Androgen deprivation therapy	ENZ+ADT+Exercise n=13 participants at risk The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training. Enzalutamide Androgen deprivation therapy Supervised exercise training
Cardiac disorders Acute coronary syndrome	7.7% 1/13 • 37 weeks Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE version 4.0)	0.00% 0/13 • 37 weeks Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE version 4.0)
Cardiac disorders Cardiac disorders - Other, Specify: RIGHT CORONARY ARTERY STENOSIS (90% OCCULUSION)	7.7% 1/13 • 37 weeks Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE version 4.0)	0.00% 0/13 • 37 weeks Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE version 4.0)
Gastrointestinal disorders Colonic obstruction	7.7% 1/13 • 37 weeks Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE version 4.0)	0.00% 0/13 • 37 weeks Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE version 4.0)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Other, Specify: SURGICAL PROCEDURE FOR INVASIVE ADENOCARCINOMA OF COLON	7.7% 1/13 • 37 weeks Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE version 4.0)	0.00% 0/13 • 37 weeks Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE version 4.0)
Surgical and medical procedures Surgical and medical procedures - Other, Specify: INGUINAL HERNIA REPAIR, LAPAROSCOPIC	7.7% 1/13 • 37 weeks Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE version 4.0)	0.00% 0/13 • 37 weeks Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE version 4.0)

Other adverse events

Additional Information

Michael Harrison, MD

Duke University

Phone: 919-668-4615

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place