Trial Outcomes & Findings for Enzalutamide Versus Standard Androgen Deprivation Therapy for the Treatment Hormone Sensitive Prostate Cancer (NCT NCT02278185)

Last Updated: 2025-05-11

Results Overview

Metabolic syndrome will be assessed at the beginning of each course and defined by the presence of 3 of the following five traits: abdominal obesity, defined as a waist circumference \> 102 cm (\> 40 in); serum triglycerides \>= 150 mg/dL (1.7 mmol/L) or drug treatment for elevated triglycerides; serum high density lipoprotein (HDL) cholesterol \< 40 mg/dL (1 mmol/L) or drug treatment for low HDL; blood pressure \>= 130/\>= 85 mmHg or drug treatment for elevated blood pressure; and fasting plasma glucose (FPG) \>= 100 mg/dL (5.6 mmol/L) or drug treatment for elevated blood glucose.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

19 participants

Primary outcome timeframe

Within the first 12 months of therapy

Results posted on

2025-05-11

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I (Enzalutamide) Patients receive enzalutamide PO QD for 12 months in the absence of disease progression or unacceptable toxicity. Enzalutamide: Given PO	Arm II (ADT) Patients receive standard of care ADT comprising one of the following at the discretion of the treating physician: leuprolide acetate, goserelin acetate, histrelin acetate, triptorelin, or degarelix SC or IM for 12 months in the absence of disease progression or unacceptable toxicity. Patients may also choose to undergo surgical castration as an alternative form of ADT. leuprolide acetate: Given SC or IM goserelin acetate: Given SC or IM histrelin acetate: Given SC or IM triptorelin: Given SC or IM degarelix: Given SC or IM
Overall Study STARTED	10	9
Overall Study COMPLETED	7	7
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Enzalutamide Versus Standard Androgen Deprivation Therapy for the Treatment Hormone Sensitive Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Enzalutamide) n=10 Participants Patients receive enzalutamide PO QD for 12 months in the absence of disease progression or unacceptable toxicity. Enzalutamide: Given PO	Arm II (ADT) n=9 Participants Patients receive standard of care ADT comprising one of the following at the discretion of the treating physician: leuprolide acetate, goserelin acetate, histrelin acetate, triptorelin, or degarelix SC or IM for 12 months in the absence of disease progression or unacceptable toxicity. Patients may also choose to undergo surgical castration as an alternative form of ADT. leuprolide acetate: Given SC or IM goserelin acetate: Given SC or IM histrelin acetate: Given SC or IM triptorelin: Given SC or IM degarelix: Given SC or IM	Total n=19 Participants Total of all reporting groups
Age, Continuous	62 years n=5 Participants	68 years n=7 Participants	66 years 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	10 Participants n=5 Participants	9 Participants n=7 Participants	19 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	10 Participants n=5 Participants	9 Participants n=7 Participants	19 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
Region of Enrollment United States	10 participants n=5 Participants	9 participants n=7 Participants	19 participants n=5 Participants
PSA value	10.86 NG/ML n=5 Participants	5.48 NG/ML n=7 Participants	7.55 NG/ML n=5 Participants
Metastatic disease	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within the first 12 months of therapy

Outcome measures

Outcome measures
Measure	Arm I (Enzalutamide) n=10 Participants Patients receive enzalutamide PO QD for 12 months in the absence of disease progression or unacceptable toxicity. Enzalutamide: Given PO	Arm II (ADT) n=9 Participants Patients receive standard of care ADT comprising one of the following at the discretion of the treating physician: leuprolide acetate, goserelin acetate, histrelin acetate, triptorelin, or degarelix SC or IM for 12 months in the absence of disease progression or unacceptable toxicity. Patients may also choose to undergo surgical castration as an alternative form of ADT. leuprolide acetate: Given SC or IM goserelin acetate: Given SC or IM histrelin acetate: Given SC or IM triptorelin: Given SC or IM degarelix: Given SC or IM
Metabolic Syndrome Incidence, Summarized by the Number of Patients With at Least 3 of the 5 Pre-specified Criteria	5 Participants	3 Participants

SECONDARY outcome

Timeframe: Within the first 6 months of therapy

Population: Includes all patients still participating at this timepoint

Metabolic syndrome will be assessed at the beginning of each course and defined by the presence of 3 of the following five traits: abdominal obesity, defined as a waist circumference \> 102 cm (\> 40 in); serum triglycerides \>= 150 mg/dL (1.7 mmol/L) or drug treatment for elevated triglycerides; serum HDL cholesterol \< 40 mg/dL (1 mmol/L) or drug treatment for low HDL; blood pressure \>= 130/\>= 85 mmHg or drug treatment for elevated blood pressure; and FPG \>= 100 mg/dL (5.6 mmol/L) or drug treatment for elevated blood glucose.

Outcome measures

Outcome measures
Measure	Arm I (Enzalutamide) n=10 Participants Patients receive enzalutamide PO QD for 12 months in the absence of disease progression or unacceptable toxicity. Enzalutamide: Given PO	Arm II (ADT) n=9 Participants Patients receive standard of care ADT comprising one of the following at the discretion of the treating physician: leuprolide acetate, goserelin acetate, histrelin acetate, triptorelin, or degarelix SC or IM for 12 months in the absence of disease progression or unacceptable toxicity. Patients may also choose to undergo surgical castration as an alternative form of ADT. leuprolide acetate: Given SC or IM goserelin acetate: Given SC or IM histrelin acetate: Given SC or IM triptorelin: Given SC or IM degarelix: Given SC or IM
Metabolic Syndrome Incidence, Summarized by the Proportion of Patients With at Least 3 of the 5 Pre-specified Criteria	4 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline and month 12

Population: Patients were compared to themselves as well as across groups. We reviewed difference from month 1 to 12 in order to gather adequate data. Below are the bone-specific alkaline phosphatase. Not all patients completed follow up for this measure.

Will be assessed for each treatment group. Measurements will be taken at day 1 of each course. A paired t-test will test within an arm as to whether the change from baseline to 12 months is significantly different from zero.

Outcome measures

Outcome measures
Measure	Arm I (Enzalutamide) n=4 Participants Patients receive enzalutamide PO QD for 12 months in the absence of disease progression or unacceptable toxicity. Enzalutamide: Given PO	Arm II (ADT) n=5 Participants Patients receive standard of care ADT comprising one of the following at the discretion of the treating physician: leuprolide acetate, goserelin acetate, histrelin acetate, triptorelin, or degarelix SC or IM for 12 months in the absence of disease progression or unacceptable toxicity. Patients may also choose to undergo surgical castration as an alternative form of ADT. leuprolide acetate: Given SC or IM goserelin acetate: Given SC or IM histrelin acetate: Given SC or IM triptorelin: Given SC or IM degarelix: Given SC or IM
Change in Bone Turnover Markers, as Measured by Bone-specific Alkaline Phosphatase	-18.55 microgram/L Standard Deviation 36.19	-58.14 microgram/L Standard Deviation 133.53

SECONDARY outcome

Timeframe: Baseline to 12 months

Population: Not all patients completed follow-up for this measure.

We will measure bone density via a DXA scanner, Left Femur and Right femur T scores will be added to a composite score. A paired t-test will test within an arm as to whether the change from baseline to twelve months is significantly different from zero. The T-score is the standard deviation of how much bone density differs from the bone mass of an average healthy 30 year old. A score of 0 indicates no deviation from average. The following ranges are used: * T-score of -1.0 or above = normal bone density * T-score between -1.0 and -2.5 = low bone density, or osteopenia * T-score of -2.5 or lower = osteoporosis

Outcome measures

Outcome measures
Measure	Arm I (Enzalutamide) n=4 Participants Patients receive enzalutamide PO QD for 12 months in the absence of disease progression or unacceptable toxicity. Enzalutamide: Given PO	Arm II (ADT) n=5 Participants Patients receive standard of care ADT comprising one of the following at the discretion of the treating physician: leuprolide acetate, goserelin acetate, histrelin acetate, triptorelin, or degarelix SC or IM for 12 months in the absence of disease progression or unacceptable toxicity. Patients may also choose to undergo surgical castration as an alternative form of ADT. leuprolide acetate: Given SC or IM goserelin acetate: Given SC or IM histrelin acetate: Given SC or IM triptorelin: Given SC or IM degarelix: Given SC or IM
Change in Bone Density	-0.23 score on a scale Standard Deviation 0.26	0 score on a scale Standard Deviation 0.29

SECONDARY outcome

Timeframe: Baseline to up to 12 months

Population: The DXA scanner was not able to analyze free fat mass, only bone density.

A paired t-test will test within an arm as to whether the change from baseline to each time point is significantly different from zero. These data are not able to be reported as the DXA did not measure free fat mass and thus we will be using cross sectional CT analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to up to 12 months

Population: data cannot be reported as the dexa scanner used for the study only measured bone density and not lean body mass (this was realized part way through study).

A paired t-test will test within an arm as to whether the change from baseline to each time point is significantly different from zero.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to up to 7 months

Population: Patients were compared to themselves as well as across groups. We reviewed difference from month 1 to 7 in order to gather adequate data. Below is the SHIM.

The FACT-P is the Functional Assessment of Cancer Therapy - Prostate and measures physical/emotional quality of life in prostate cancer patients. NUMBER OF ITEMS:39 PATIENT POPULATION:Prostate cancer patients 18 years and older RECALL PERIOD:Past 7 days RESPONSE SCALE:5 point Likert-type scale SUBSCALE DOMAINS: Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB), Functional Well-Being (FWB), Prostate Cancer Subscale (PCS) SCORING: Scores range from 0-158. In general, the higher the score, the better the quality of life. Sexual Health in Men (SHIM). 5 item measure of erectile function. Total score is 1-25 with a higher score indicating better sexual health. Scores: no ED (SHIM total score, 22-25), mild (17-21), mild to moderate (12-16), moderate (8-11), and severe ED (1-7).

Outcome measures

Outcome measures
Measure	Arm I (Enzalutamide) n=10 Participants Patients receive enzalutamide PO QD for 12 months in the absence of disease progression or unacceptable toxicity. Enzalutamide: Given PO	Arm II (ADT) n=9 Participants Patients receive standard of care ADT comprising one of the following at the discretion of the treating physician: leuprolide acetate, goserelin acetate, histrelin acetate, triptorelin, or degarelix SC or IM for 12 months in the absence of disease progression or unacceptable toxicity. Patients may also choose to undergo surgical castration as an alternative form of ADT. leuprolide acetate: Given SC or IM goserelin acetate: Given SC or IM histrelin acetate: Given SC or IM triptorelin: Given SC or IM degarelix: Given SC or IM
Change in Quality of Life (QOL) Scores, as Measured by the Functional Assessment of Cancer Therapy - Prostate (FACT-P) and Sexual Health in Men (SHIM) SHIM	-3.71 score on a scale Standard Deviation 5.06	-3.4 score on a scale Standard Deviation 5.98
Change in Quality of Life (QOL) Scores, as Measured by the Functional Assessment of Cancer Therapy - Prostate (FACT-P) and Sexual Health in Men (SHIM) FACT-P	-4.5 score on a scale Standard Deviation 10.15	-1.93 score on a scale Standard Deviation 6.82

SECONDARY outcome

Timeframe: Time from randomization to the earliest objective evidence of PSA progression as defined per protocol, assessed up to 30 days after the last dose of study drug

Population: All patients were evaluated throughout the course of the study

PSA progression as defined by an increase in \>= 50% from nadir and an absolute increase of at least 2 ng/mL above the nadir, occurring at least 12 weeks after start of therapy that is confirmed by two consecutive increases taken at least 2 weeks apart. Log rank test will be used to compare the distributions of above variables between the group treated with enzalutamide to the group on standard ADT.

Outcome measures

Outcome measures
Measure	Arm I (Enzalutamide) n=10 Participants Patients receive enzalutamide PO QD for 12 months in the absence of disease progression or unacceptable toxicity. Enzalutamide: Given PO	Arm II (ADT) n=9 Participants Patients receive standard of care ADT comprising one of the following at the discretion of the treating physician: leuprolide acetate, goserelin acetate, histrelin acetate, triptorelin, or degarelix SC or IM for 12 months in the absence of disease progression or unacceptable toxicity. Patients may also choose to undergo surgical castration as an alternative form of ADT. leuprolide acetate: Given SC or IM goserelin acetate: Given SC or IM histrelin acetate: Given SC or IM triptorelin: Given SC or IM degarelix: Given SC or IM
Number of Patients With PSA Progression	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Time from randomization to the earliest objective evidence of radiographic progression as defined per protocol, assessed up to 30 days after the last dose of study drug

Population: All participants included in analysis.

Log rank test will be used to compare the distributions of above variables between the group treated with enzalutamide to the group on standard ADT.

Outcome measures

Outcome measures
Measure	Arm I (Enzalutamide) n=10 Participants Patients receive enzalutamide PO QD for 12 months in the absence of disease progression or unacceptable toxicity. Enzalutamide: Given PO	Arm II (ADT) n=9 Participants Patients receive standard of care ADT comprising one of the following at the discretion of the treating physician: leuprolide acetate, goserelin acetate, histrelin acetate, triptorelin, or degarelix SC or IM for 12 months in the absence of disease progression or unacceptable toxicity. Patients may also choose to undergo surgical castration as an alternative form of ADT. leuprolide acetate: Given SC or IM goserelin acetate: Given SC or IM histrelin acetate: Given SC or IM triptorelin: Given SC or IM degarelix: Given SC or IM
Time to Radiographic Progression	NA Months Standard Deviation NA No patients on study experienced radiographic progression within the study period.	11.474 Months Standard Deviation NA Only one patient experienced radiographic progression within the study period.

SECONDARY outcome

Timeframe: Difference between baseline and 12 months.

Population: Patients were compared to themselves as well as across groups. We reviewed difference from month 1 to 12 in order to gather adequate data. Some patients in the cohort were missing follow-up data.

Mean change in available samples from baseline to 12 months, presented in mg/dL

Outcome measures

Outcome measures
Measure	Arm I (Enzalutamide) n=6 Participants Patients receive enzalutamide PO QD for 12 months in the absence of disease progression or unacceptable toxicity. Enzalutamide: Given PO	Arm II (ADT) n=6 Participants Patients receive standard of care ADT comprising one of the following at the discretion of the treating physician: leuprolide acetate, goserelin acetate, histrelin acetate, triptorelin, or degarelix SC or IM for 12 months in the absence of disease progression or unacceptable toxicity. Patients may also choose to undergo surgical castration as an alternative form of ADT. leuprolide acetate: Given SC or IM goserelin acetate: Given SC or IM histrelin acetate: Given SC or IM triptorelin: Given SC or IM degarelix: Given SC or IM
Change in Markers of Inflammation, as Measured by Circulating Hs-CRP	0.87 mg/dL Standard Deviation 1.99	6.42 mg/dL Standard Deviation 16.47

SECONDARY outcome

Timeframe: Up to 30 days after the last dose of study drug

Population: adverse events reported in separate section

The incidence of adverse events has been reported in the adverse events log for clinicaltrials.gov

Outcome measures

Outcome measures
Measure	Arm I (Enzalutamide) n=10 Participants Patients receive enzalutamide PO QD for 12 months in the absence of disease progression or unacceptable toxicity. Enzalutamide: Given PO	Arm II (ADT) n=9 Participants Patients receive standard of care ADT comprising one of the following at the discretion of the treating physician: leuprolide acetate, goserelin acetate, histrelin acetate, triptorelin, or degarelix SC or IM for 12 months in the absence of disease progression or unacceptable toxicity. Patients may also choose to undergo surgical castration as an alternative form of ADT. leuprolide acetate: Given SC or IM goserelin acetate: Given SC or IM histrelin acetate: Given SC or IM triptorelin: Given SC or IM degarelix: Given SC or IM
Incidence of Adverse Events, Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.1	10 Participants	9 Participants

SECONDARY outcome

Timeframe: Difference between baseline and 12 months.

Population: Not all patients completed follow-up for this measure.

The Short SPPB incorporates 3 validated portions to assess a patient's balance and mobility. SPPB scores range from zero to 12 possible points. SPPB score of 3-9 points in persons with no mobility disability indicates frailty; SPPB score of 10 or greater for persons with no sarcopenia and no mobility disability indicates robustness. The higher the score, the better the physical function. Will be measured as a continuous outcome.

Outcome measures

Outcome measures
Measure	Arm I (Enzalutamide) n=5 Participants Patients receive enzalutamide PO QD for 12 months in the absence of disease progression or unacceptable toxicity. Enzalutamide: Given PO	Arm II (ADT) n=6 Participants Patients receive standard of care ADT comprising one of the following at the discretion of the treating physician: leuprolide acetate, goserelin acetate, histrelin acetate, triptorelin, or degarelix SC or IM for 12 months in the absence of disease progression or unacceptable toxicity. Patients may also choose to undergo surgical castration as an alternative form of ADT. leuprolide acetate: Given SC or IM goserelin acetate: Given SC or IM histrelin acetate: Given SC or IM triptorelin: Given SC or IM degarelix: Given SC or IM
Change in Physical Function, as Measured by Short Physical Performance Battery (SPPB).	10.58 score on a scale Standard Deviation 1.39	10.94 score on a scale Standard Deviation 1.97

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: Patients were compared to themselves as well as across groups. We reviewed difference from month 1 to 12 to gather adequate data. Below are the N-telopeptide. Not all patients completed follow-up for this measure.

Will be assessed for each treatment group. Measurements will be taken at day 1 of each course. A paired t-test within an arm as to whether the change from baseline to 12 months is significantly different from zero. N-Telopeptide units - nM Bone Collagen Equivalent (BCE).

Outcome measures

Outcome measures
Measure	Arm I (Enzalutamide) n=6 Participants Patients receive enzalutamide PO QD for 12 months in the absence of disease progression or unacceptable toxicity. Enzalutamide: Given PO	Arm II (ADT) n=7 Participants Patients receive standard of care ADT comprising one of the following at the discretion of the treating physician: leuprolide acetate, goserelin acetate, histrelin acetate, triptorelin, or degarelix SC or IM for 12 months in the absence of disease progression or unacceptable toxicity. Patients may also choose to undergo surgical castration as an alternative form of ADT. leuprolide acetate: Given SC or IM goserelin acetate: Given SC or IM histrelin acetate: Given SC or IM triptorelin: Given SC or IM degarelix: Given SC or IM
Change in Bone Turnover Markers as Measured by N-telopeptide	-3.05 nM BCE Standard Deviation 5.51	1.73 nM BCE Standard Deviation 8.41

Adverse Events

Arm I (Enzalutamide)

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Arm II (ADT)

Serious events: 3 serious events

Other events: 9 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Arm I (Enzalutamide) n=10 participants at risk Patients receive enzalutamide PO QD for 12 months in the absence of disease progression or unacceptable toxicity. Enzalutamide: Given PO	Arm II (ADT) n=9 participants at risk Patients receive standard of care ADT comprising one of the following at the discretion of the treating physician: leuprolide acetate, goserelin acetate, histrelin acetate, triptorelin, or degarelix SC or IM for 12 months in the absence of disease progression or unacceptable toxicity. Patients may also choose to undergo surgical castration as an alternative form of ADT. leuprolide acetate: Given SC or IM goserelin acetate: Given SC or IM histrelin acetate: Given SC or IM triptorelin: Given SC or IM degarelix: Given SC or IM
Nervous system disorders Subarachnoid Hemmorhage	0.00% 0/10 • Monitoring of adverse events was conducted throughout the study. These were reported from the date written informed consent and through 30 days post-last dose of study drug. There is no difference in our definition of an adverse event and that of clinicaltrials.gov	11.1% 1/9 • Number of events 1 • Monitoring of adverse events was conducted throughout the study. These were reported from the date written informed consent and through 30 days post-last dose of study drug. There is no difference in our definition of an adverse event and that of clinicaltrials.gov
Gastrointestinal disorders Radiation esophagitis	0.00% 0/10 • Monitoring of adverse events was conducted throughout the study. These were reported from the date written informed consent and through 30 days post-last dose of study drug. There is no difference in our definition of an adverse event and that of clinicaltrials.gov	11.1% 1/9 • Number of events 1 • Monitoring of adverse events was conducted throughout the study. These were reported from the date written informed consent and through 30 days post-last dose of study drug. There is no difference in our definition of an adverse event and that of clinicaltrials.gov
Metabolism and nutrition disorders Hypertriglyceridemia	10.0% 1/10 • Number of events 1 • Monitoring of adverse events was conducted throughout the study. These were reported from the date written informed consent and through 30 days post-last dose of study drug. There is no difference in our definition of an adverse event and that of clinicaltrials.gov	0.00% 0/9 • Monitoring of adverse events was conducted throughout the study. These were reported from the date written informed consent and through 30 days post-last dose of study drug. There is no difference in our definition of an adverse event and that of clinicaltrials.gov
Nervous system disorders Spinal cord compression	0.00% 0/10 • Monitoring of adverse events was conducted throughout the study. These were reported from the date written informed consent and through 30 days post-last dose of study drug. There is no difference in our definition of an adverse event and that of clinicaltrials.gov	11.1% 1/9 • Number of events 1 • Monitoring of adverse events was conducted throughout the study. These were reported from the date written informed consent and through 30 days post-last dose of study drug. There is no difference in our definition of an adverse event and that of clinicaltrials.gov

Other adverse events

Additional Information

Dr. Elizabeth R Kessler

University of Colorado School of Medicine

Phone: 720-848-0402

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place