Trial Outcomes & Findings for Testosterone Revival Abolishes Negative Symptoms, Fosters Objective Response and Modulates Enzalutamide Resistance (NCT NCT02286921)
NCT ID: NCT02286921
Last Updated: 2020-11-06
Results Overview
Time to clinical progression will be defined as months from randomization to any of the following (whichever occurs earlier): * Cancer pain requiring initiation of chronic administration of opiate analgesia (oral opiate use for ≥3 weeks; parenteral opiate use for ≥7 days. Patients with cancer pain requiring opiate analgesia for relief should also be assessed by the investigator for the need for initiating systemic chemotherapy or palliative radiation. * Development of a skeletal-related event (SRE): pathologic fracture, spinal cord compression, or need for surgical intervention or radiation therapy to the bone. * Development of clinically significant symptoms due to loco-regional tumor progression (e.g. urinary obstruction) requiring surgical intervention or radiation therapy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
222 participants
Primary outcome timeframe
up to 2 years
Results posted on
2020-11-06
Participant Flow
27 participants were not assigned to intervention due to screen failure, withdrawn consent, or PI decision.
Participant milestones
| Measure |
Arm A: Testosterone Cypionate or Testosterone Enanthate
Patients on BAT will receive testosterone cypionate or testosterone enanthate administered as an intramuscular injection. A dose of 400 mg of either agent will be injected intramuscularly (IM) every 28 days.
Testosterone cypionate: Depo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. Depo-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.
Testosterone Enanthate: Testosterone Enanthate Injection, for intramuscular injection, contains testosterone enanthate which is the oil-soluble ester of the androgenic hormone testosterone. Enanthate Injection is available as a colorless to pale yellow solution. Each mL contains 200 mg testosterone enanthate in sesame oil with 5 mg chlorobutanol as a preservative.
|
Arm B: Enzalutamide
Patients randomized to enzalutamide will be prescribed enzalutamide 40 mg tablets and instructed to take 4 tablets per day orally for 28 days/cycle.
Enzalutamide: Enzalutamide is a white crystalline non-hygroscopic solid. It is practically insoluble in water. Enzalutamide is provided as liquid-filled soft gelatin capsules for oral administration. Each capsule contains 40 mg of enzalutamide as a solution in caprylocaproyl polyoxylglycerides. The inactive ingredients are caprylocaproyl polyoxylglycerides, butylated hydroxyanisole, butylated hydroxytoluene, gelatin, sorbitol sorbitan solution, glycerin, purified water, titanium dioxide, and black iron oxide.
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|---|---|---|
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Overall Study
STARTED
|
94
|
101
|
|
Overall Study
COMPLETED
|
94
|
101
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data collected for BMI in 93/94 at Arm A and 95/101 at Arm B.
Baseline characteristics by cohort
| Measure |
Arm A: Testosterone Cypionate or Testosterone Enanthate
n=94 Participants
Patients on BAT will receive testosterone cypionate or testosterone enanthate administered as an intramuscular injection. A dose of 400 mg of either agent will be injected intramuscularly (IM) every 28 days.
Testosterone cypionate: Depo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. Depo-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.
Testosterone Enanthate: Testosterone Enanthate Injection, for intramuscular injection, contains testosterone enanthate which is the oil-soluble ester of the androgenic hormone testosterone. Enanthate Injection is available as a colorless to pale yellow solution. Each mL contains 200 mg testosterone enanthate in sesame oil with 5 mg chlorobutanol as a preservative.
|
Arm B: Enzalutamide
n=101 Participants
Patients randomized to enzalutamide will be prescribed enzalutamide 40 mg tablets and instructed to take 4 tablets per day orally for 28 days/cycle.
Enzalutamide: Enzalutamide is a white crystalline non-hygroscopic solid. It is practically insoluble in water. Enzalutamide is provided as liquid-filled soft gelatin capsules for oral administration. Each capsule contains 40 mg of enzalutamide as a solution in caprylocaproyl polyoxylglycerides. The inactive ingredients are caprylocaproyl polyoxylglycerides, butylated hydroxyanisole, butylated hydroxytoluene, gelatin, sorbitol sorbitan solution, glycerin, purified water, titanium dioxide, and black iron oxide.
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Total
n=195 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
70.6 years
STANDARD_DEVIATION 8.05 • n=94 Participants
|
70.4 years
STANDARD_DEVIATION 7.59 • n=101 Participants
|
70.5 years
STANDARD_DEVIATION 7.80 • n=195 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=94 Participants
|
0 Participants
n=101 Participants
|
0 Participants
n=195 Participants
|
|
Sex: Female, Male
Male
|
94 Participants
n=94 Participants
|
101 Participants
n=101 Participants
|
195 Participants
n=195 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=94 Participants
|
0 Participants
n=101 Participants
|
1 Participants
n=195 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=94 Participants
|
3 Participants
n=101 Participants
|
5 Participants
n=195 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
7 Participants
n=94 Participants
|
7 Participants
n=101 Participants
|
14 Participants
n=195 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=94 Participants
|
0 Participants
n=101 Participants
|
0 Participants
n=195 Participants
|
|
Race/Ethnicity, Customized
White
|
82 Participants
n=94 Participants
|
88 Participants
n=101 Participants
|
170 Participants
n=195 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=94 Participants
|
3 Participants
n=101 Participants
|
5 Participants
n=195 Participants
|
|
Region of Enrollment
United States
|
94 Participants
n=94 Participants
|
101 Participants
n=101 Participants
|
195 Participants
n=195 Participants
|
|
Weight (kg)
|
93.8 Kilogram
STANDARD_DEVIATION 17.7 • n=94 Participants
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94.4 Kilogram
STANDARD_DEVIATION 19.7 • n=101 Participants
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94.1 Kilogram
STANDARD_DEVIATION 18.7 • n=195 Participants
|
|
Height (cm)
|
176.5 centimeters
STANDARD_DEVIATION 7.26 • n=94 Participants
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175.2 centimeters
STANDARD_DEVIATION 12.4 • n=101 Participants
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175.8 centimeters
STANDARD_DEVIATION 10.2 • n=195 Participants
|
|
Body Mass Index (BMI)
|
29.9 Kilogram per meter square (Kg/m^2)
STANDARD_DEVIATION 5.96 • n=93 Participants • Data collected for BMI in 93/94 at Arm A and 95/101 at Arm B.
|
29.7 Kilogram per meter square (Kg/m^2)
STANDARD_DEVIATION 7.17 • n=95 Participants • Data collected for BMI in 93/94 at Arm A and 95/101 at Arm B.
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29.8 Kilogram per meter square (Kg/m^2)
STANDARD_DEVIATION 6.58 • n=188 Participants • Data collected for BMI in 93/94 at Arm A and 95/101 at Arm B.
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0
|
53 Participants
n=94 Participants • Data collected for ECOG performance status in 99/101 at Arm B.
|
73 Participants
n=99 Participants • Data collected for ECOG performance status in 99/101 at Arm B.
|
126 Participants
n=193 Participants • Data collected for ECOG performance status in 99/101 at Arm B.
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1
|
40 Participants
n=94 Participants • Data collected for ECOG performance status in 99/101 at Arm B.
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25 Participants
n=101 Participants • Data collected for ECOG performance status in 99/101 at Arm B.
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65 Participants
n=195 Participants • Data collected for ECOG performance status in 99/101 at Arm B.
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
2
|
1 Participants
n=94 Participants • Data collected for ECOG performance status in 99/101 at Arm B.
|
1 Participants
n=101 Participants • Data collected for ECOG performance status in 99/101 at Arm B.
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2 Participants
n=195 Participants • Data collected for ECOG performance status in 99/101 at Arm B.
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PRIMARY outcome
Timeframe: up to 2 yearsTime to clinical progression will be defined as months from randomization to any of the following (whichever occurs earlier): * Cancer pain requiring initiation of chronic administration of opiate analgesia (oral opiate use for ≥3 weeks; parenteral opiate use for ≥7 days. Patients with cancer pain requiring opiate analgesia for relief should also be assessed by the investigator for the need for initiating systemic chemotherapy or palliative radiation. * Development of a skeletal-related event (SRE): pathologic fracture, spinal cord compression, or need for surgical intervention or radiation therapy to the bone. * Development of clinically significant symptoms due to loco-regional tumor progression (e.g. urinary obstruction) requiring surgical intervention or radiation therapy.
Outcome measures
| Measure |
Arm A: Testosterone Cypionate or Testosterone Enanthate
n=94 Participants
Patients on BAT will receive testosterone cypionate or testosterone enanthate administered as an intramuscular injection. A dose of 400 mg of either agent will be injected intramuscularly (IM) every 28 days.
Testosterone cypionate: Depo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. Depo-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.
Testosterone Enanthate: Testosterone Enanthate Injection, for intramuscular injection, contains testosterone enanthate which is the oil-soluble ester of the androgenic hormone testosterone. Enanthate Injection is available as a colorless to pale yellow solution. Each mL contains 200 mg testosterone enanthate in sesame oil with 5 mg chlorobutanol as a preservative.
|
Arm B: Enzalutamide
n=101 Participants
Patients randomized to enzalutamide will be prescribed enzalutamide 40 mg tablets and instructed to take 4 tablets per day orally for 28 days/cycle.
Enzalutamide: Enzalutamide is a white crystalline non-hygroscopic solid. It is practically insoluble in water. Enzalutamide is provided as liquid-filled soft gelatin capsules for oral administration. Each capsule contains 40 mg of enzalutamide as a solution in caprylocaproyl polyoxylglycerides. The inactive ingredients are caprylocaproyl polyoxylglycerides, butylated hydroxyanisole, butylated hydroxytoluene, gelatin, sorbitol sorbitan solution, glycerin, purified water, titanium dioxide, and black iron oxide.
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|---|---|---|
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Progression Free Survival as Measured by Number of Months Until Clinical or Radiographic Progression
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5.62 months
Interval 4.76 to 5.91
|
5.72 months
Interval 3.78 to 8.34
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SECONDARY outcome
Timeframe: up to 2 yearsNumber of months until 20% increase in the sum of target lesions on CT scans.
Outcome measures
| Measure |
Arm A: Testosterone Cypionate or Testosterone Enanthate
n=94 Participants
Patients on BAT will receive testosterone cypionate or testosterone enanthate administered as an intramuscular injection. A dose of 400 mg of either agent will be injected intramuscularly (IM) every 28 days.
Testosterone cypionate: Depo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. Depo-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.
Testosterone Enanthate: Testosterone Enanthate Injection, for intramuscular injection, contains testosterone enanthate which is the oil-soluble ester of the androgenic hormone testosterone. Enanthate Injection is available as a colorless to pale yellow solution. Each mL contains 200 mg testosterone enanthate in sesame oil with 5 mg chlorobutanol as a preservative.
|
Arm B: Enzalutamide
n=101 Participants
Patients randomized to enzalutamide will be prescribed enzalutamide 40 mg tablets and instructed to take 4 tablets per day orally for 28 days/cycle.
Enzalutamide: Enzalutamide is a white crystalline non-hygroscopic solid. It is practically insoluble in water. Enzalutamide is provided as liquid-filled soft gelatin capsules for oral administration. Each capsule contains 40 mg of enzalutamide as a solution in caprylocaproyl polyoxylglycerides. The inactive ingredients are caprylocaproyl polyoxylglycerides, butylated hydroxyanisole, butylated hydroxytoluene, gelatin, sorbitol sorbitan solution, glycerin, purified water, titanium dioxide, and black iron oxide.
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|---|---|---|
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Radiographic Progression
|
5.75 months
Interval 5.55 to 8.41
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8.28 months
Interval 5.52 to 11.07
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Data was not evaluable for this outcome measure in 7/94 participants from arm A and 7/101 participants from arm B.
Number of participants achieving a Prostate-Specific Antigen decline ≥ 50% according to Prostate Cancer Working Group (PCWG2) criteria.
Outcome measures
| Measure |
Arm A: Testosterone Cypionate or Testosterone Enanthate
n=87 Participants
Patients on BAT will receive testosterone cypionate or testosterone enanthate administered as an intramuscular injection. A dose of 400 mg of either agent will be injected intramuscularly (IM) every 28 days.
Testosterone cypionate: Depo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. Depo-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.
Testosterone Enanthate: Testosterone Enanthate Injection, for intramuscular injection, contains testosterone enanthate which is the oil-soluble ester of the androgenic hormone testosterone. Enanthate Injection is available as a colorless to pale yellow solution. Each mL contains 200 mg testosterone enanthate in sesame oil with 5 mg chlorobutanol as a preservative.
|
Arm B: Enzalutamide
n=94 Participants
Patients randomized to enzalutamide will be prescribed enzalutamide 40 mg tablets and instructed to take 4 tablets per day orally for 28 days/cycle.
Enzalutamide: Enzalutamide is a white crystalline non-hygroscopic solid. It is practically insoluble in water. Enzalutamide is provided as liquid-filled soft gelatin capsules for oral administration. Each capsule contains 40 mg of enzalutamide as a solution in caprylocaproyl polyoxylglycerides. The inactive ingredients are caprylocaproyl polyoxylglycerides, butylated hydroxyanisole, butylated hydroxytoluene, gelatin, sorbitol sorbitan solution, glycerin, purified water, titanium dioxide, and black iron oxide.
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|---|---|---|
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Prostate-Specific Antigen Response Rate
|
14 Participants
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18 Participants
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SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Only participants with at least one post-baseline assessment were included to assess this outcome measure. Data was not evaluable in 61/94 participants from arm A and 77/101 participants from arm B.
Number of participants with partial (PR) or complete response (CR) as defined by response evaluation criteria in solid tumors (RECIST), where CR is a disappearance of all target lesions and PR is ≥30% reduction in the sum of the longest diameter of target lesions.
Outcome measures
| Measure |
Arm A: Testosterone Cypionate or Testosterone Enanthate
n=33 Participants
Patients on BAT will receive testosterone cypionate or testosterone enanthate administered as an intramuscular injection. A dose of 400 mg of either agent will be injected intramuscularly (IM) every 28 days.
Testosterone cypionate: Depo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. Depo-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.
Testosterone Enanthate: Testosterone Enanthate Injection, for intramuscular injection, contains testosterone enanthate which is the oil-soluble ester of the androgenic hormone testosterone. Enanthate Injection is available as a colorless to pale yellow solution. Each mL contains 200 mg testosterone enanthate in sesame oil with 5 mg chlorobutanol as a preservative.
|
Arm B: Enzalutamide
n=24 Participants
Patients randomized to enzalutamide will be prescribed enzalutamide 40 mg tablets and instructed to take 4 tablets per day orally for 28 days/cycle.
Enzalutamide: Enzalutamide is a white crystalline non-hygroscopic solid. It is practically insoluble in water. Enzalutamide is provided as liquid-filled soft gelatin capsules for oral administration. Each capsule contains 40 mg of enzalutamide as a solution in caprylocaproyl polyoxylglycerides. The inactive ingredients are caprylocaproyl polyoxylglycerides, butylated hydroxyanisole, butylated hydroxytoluene, gelatin, sorbitol sorbitan solution, glycerin, purified water, titanium dioxide, and black iron oxide.
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|---|---|---|
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Objective Response Rate as Determined by RECIST
|
8 Participants
|
1 Participants
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SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Date is not evaluable for this outcome measure in 3/94 participants from arm A and 3/101 participants from arm B.
Reported as number of months till Prostate-Specific Antigen increase of greater or equal to 50% according to Prostate Cancer Working Group (PCWG2) criteria.
Outcome measures
| Measure |
Arm A: Testosterone Cypionate or Testosterone Enanthate
n=91 Participants
Patients on BAT will receive testosterone cypionate or testosterone enanthate administered as an intramuscular injection. A dose of 400 mg of either agent will be injected intramuscularly (IM) every 28 days.
Testosterone cypionate: Depo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. Depo-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.
Testosterone Enanthate: Testosterone Enanthate Injection, for intramuscular injection, contains testosterone enanthate which is the oil-soluble ester of the androgenic hormone testosterone. Enanthate Injection is available as a colorless to pale yellow solution. Each mL contains 200 mg testosterone enanthate in sesame oil with 5 mg chlorobutanol as a preservative.
|
Arm B: Enzalutamide
n=98 Participants
Patients randomized to enzalutamide will be prescribed enzalutamide 40 mg tablets and instructed to take 4 tablets per day orally for 28 days/cycle.
Enzalutamide: Enzalutamide is a white crystalline non-hygroscopic solid. It is practically insoluble in water. Enzalutamide is provided as liquid-filled soft gelatin capsules for oral administration. Each capsule contains 40 mg of enzalutamide as a solution in caprylocaproyl polyoxylglycerides. The inactive ingredients are caprylocaproyl polyoxylglycerides, butylated hydroxyanisole, butylated hydroxytoluene, gelatin, sorbitol sorbitan solution, glycerin, purified water, titanium dioxide, and black iron oxide.
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|---|---|---|
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Time to Prostate-Specific Antigen Progression
|
2.79 month
Interval 1.81 to 4.5
|
3.81 month
Interval 2.76 to 5.59
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SECONDARY outcome
Timeframe: up to 1 yearPopulation: Questionnaires were not completed by all participants. Therefore, data was only collected from: Arm A- 87/94 at baseline, 81/94 at month 1, 71/94 at month 3, 54/94 at month 6 and 17/94 at month 12. Arm B- 93/101 at baseline, 86/101 at month 1, 75/101 at month 3, 55/101 at month 6 and 25/101 at month 12.
The Positive Affect Score is calculated by adding the scores on items 1, 3, 5, 9, 10, 12, 14, 16, 17, and 19. Scores can range from 10 - 50, with higher scores representing higher levels of positive affect.
Outcome measures
| Measure |
Arm A: Testosterone Cypionate or Testosterone Enanthate
n=94 Participants
Patients on BAT will receive testosterone cypionate or testosterone enanthate administered as an intramuscular injection. A dose of 400 mg of either agent will be injected intramuscularly (IM) every 28 days.
Testosterone cypionate: Depo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. Depo-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.
Testosterone Enanthate: Testosterone Enanthate Injection, for intramuscular injection, contains testosterone enanthate which is the oil-soluble ester of the androgenic hormone testosterone. Enanthate Injection is available as a colorless to pale yellow solution. Each mL contains 200 mg testosterone enanthate in sesame oil with 5 mg chlorobutanol as a preservative.
|
Arm B: Enzalutamide
n=101 Participants
Patients randomized to enzalutamide will be prescribed enzalutamide 40 mg tablets and instructed to take 4 tablets per day orally for 28 days/cycle.
Enzalutamide: Enzalutamide is a white crystalline non-hygroscopic solid. It is practically insoluble in water. Enzalutamide is provided as liquid-filled soft gelatin capsules for oral administration. Each capsule contains 40 mg of enzalutamide as a solution in caprylocaproyl polyoxylglycerides. The inactive ingredients are caprylocaproyl polyoxylglycerides, butylated hydroxyanisole, butylated hydroxytoluene, gelatin, sorbitol sorbitan solution, glycerin, purified water, titanium dioxide, and black iron oxide.
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|---|---|---|
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Quality of Life as Assessed by the Positive Affect Score of the Positive and Negative Affect Schedule (PANAS)
Baseline
|
33.99 score on a scale
Standard Deviation 8.69
|
32.35 score on a scale
Standard Deviation 8.58
|
|
Quality of Life as Assessed by the Positive Affect Score of the Positive and Negative Affect Schedule (PANAS)
Month 1
|
33.72 score on a scale
Standard Deviation 8.46
|
32.33 score on a scale
Standard Deviation 7.75
|
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Quality of Life as Assessed by the Positive Affect Score of the Positive and Negative Affect Schedule (PANAS)
Month 3
|
33.23 score on a scale
Standard Deviation 9.34
|
31.48 score on a scale
Standard Deviation 7.67
|
|
Quality of Life as Assessed by the Positive Affect Score of the Positive and Negative Affect Schedule (PANAS)
Month 6
|
33.96 score on a scale
Standard Deviation 9.80
|
31.84 score on a scale
Standard Deviation 7.81
|
|
Quality of Life as Assessed by the Positive Affect Score of the Positive and Negative Affect Schedule (PANAS)
Month 12
|
36.24 score on a scale
Standard Deviation 5.66
|
29.88 score on a scale
Standard Deviation 8.54
|
SECONDARY outcome
Timeframe: up to 1 yearPopulation: Questionnaires were not completed by all participants. Therefore, data was only collected from: Arm A- 87/94 at baseline, 81/94 at month 1, 71/94 at month 3, 54/94 at month 6 and 17/94 at month 12.Arm B- 93/101 at baseline, 86/101 at month 1, 75/101 at month 3, 55/101 at month 6 and 25/101 at month 12.
The Negative Affect Score is calculated by adding the scores on items 2, 4, 6, 7, 8, 11, 13, 15, 18, and 20. Scores can range from 10 - 50, with lower scores representing lower levels of negative affect.
Outcome measures
| Measure |
Arm A: Testosterone Cypionate or Testosterone Enanthate
n=94 Participants
Patients on BAT will receive testosterone cypionate or testosterone enanthate administered as an intramuscular injection. A dose of 400 mg of either agent will be injected intramuscularly (IM) every 28 days.
Testosterone cypionate: Depo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. Depo-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.
Testosterone Enanthate: Testosterone Enanthate Injection, for intramuscular injection, contains testosterone enanthate which is the oil-soluble ester of the androgenic hormone testosterone. Enanthate Injection is available as a colorless to pale yellow solution. Each mL contains 200 mg testosterone enanthate in sesame oil with 5 mg chlorobutanol as a preservative.
|
Arm B: Enzalutamide
n=101 Participants
Patients randomized to enzalutamide will be prescribed enzalutamide 40 mg tablets and instructed to take 4 tablets per day orally for 28 days/cycle.
Enzalutamide: Enzalutamide is a white crystalline non-hygroscopic solid. It is practically insoluble in water. Enzalutamide is provided as liquid-filled soft gelatin capsules for oral administration. Each capsule contains 40 mg of enzalutamide as a solution in caprylocaproyl polyoxylglycerides. The inactive ingredients are caprylocaproyl polyoxylglycerides, butylated hydroxyanisole, butylated hydroxytoluene, gelatin, sorbitol sorbitan solution, glycerin, purified water, titanium dioxide, and black iron oxide.
|
|---|---|---|
|
Quality of Life as Assessed by the Negative Affect Score of the Positive and Negative Affect Schedule (PANAS)
Baseline
|
13.89 score on a scale
Standard Deviation 4.89
|
13.96 score on a scale
Standard Deviation 4.75
|
|
Quality of Life as Assessed by the Negative Affect Score of the Positive and Negative Affect Schedule (PANAS)
Month 1
|
14.28 score on a scale
Standard Deviation 5.81
|
14.90 score on a scale
Standard Deviation 6.16
|
|
Quality of Life as Assessed by the Negative Affect Score of the Positive and Negative Affect Schedule (PANAS)
Month 3
|
14.44 score on a scale
Standard Deviation 5.52
|
15.43 score on a scale
Standard Deviation 6.54
|
|
Quality of Life as Assessed by the Negative Affect Score of the Positive and Negative Affect Schedule (PANAS)
Month 6
|
14.26 score on a scale
Standard Deviation 6.13
|
14.80 score on a scale
Standard Deviation 6.20
|
|
Quality of Life as Assessed by the Negative Affect Score of the Positive and Negative Affect Schedule (PANAS)
Month 12
|
14.24 score on a scale
Standard Deviation 6.45
|
13.48 score on a scale
Standard Deviation 3.64
|
SECONDARY outcome
Timeframe: up to 1 yearPopulation: Questionnaires were not completed by all participants. Therefore, data was only collected from: Arm A- 72/94 at baseline to month 1, 63/94 at month 3, 42/94 at month 6, and 14/94 at month 12. Arm B- 74/101 at month 1, 57/101 at month 3, 46/101 at month 6 and 20/101 at month 12.
The IIEF assesses erectile function (EF), orgasmic function (OF), sexual desire (SD), intercourse satisfaction (IS), orgasmic satisfaction (OS). Each of domains are scored on a scale of 0 to 5 with a lower score indicating a bad quality sex life. The IIEF questionnaire has a total score that ranges from 5 to 25 with lower score indicating less erectile dysfunction. A positive change in the score reflects better outcome.
Outcome measures
| Measure |
Arm A: Testosterone Cypionate or Testosterone Enanthate
n=94 Participants
Patients on BAT will receive testosterone cypionate or testosterone enanthate administered as an intramuscular injection. A dose of 400 mg of either agent will be injected intramuscularly (IM) every 28 days.
Testosterone cypionate: Depo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. Depo-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.
Testosterone Enanthate: Testosterone Enanthate Injection, for intramuscular injection, contains testosterone enanthate which is the oil-soluble ester of the androgenic hormone testosterone. Enanthate Injection is available as a colorless to pale yellow solution. Each mL contains 200 mg testosterone enanthate in sesame oil with 5 mg chlorobutanol as a preservative.
|
Arm B: Enzalutamide
n=101 Participants
Patients randomized to enzalutamide will be prescribed enzalutamide 40 mg tablets and instructed to take 4 tablets per day orally for 28 days/cycle.
Enzalutamide: Enzalutamide is a white crystalline non-hygroscopic solid. It is practically insoluble in water. Enzalutamide is provided as liquid-filled soft gelatin capsules for oral administration. Each capsule contains 40 mg of enzalutamide as a solution in caprylocaproyl polyoxylglycerides. The inactive ingredients are caprylocaproyl polyoxylglycerides, butylated hydroxyanisole, butylated hydroxytoluene, gelatin, sorbitol sorbitan solution, glycerin, purified water, titanium dioxide, and black iron oxide.
|
|---|---|---|
|
Change in Quality of Life as Assessed by the International Index of Erectile Function (IIEF) Questionnaire
EF - baseline to month 1
|
1.17 score on a scale
Standard Deviation 4.56
|
0.09 score on a scale
Standard Deviation 1.84
|
|
Change in Quality of Life as Assessed by the International Index of Erectile Function (IIEF) Questionnaire
SD - baseline to month 6
|
2.52 score on a scale
Standard Deviation 2.59
|
0.18 score on a scale
Standard Deviation 1.77
|
|
Change in Quality of Life as Assessed by the International Index of Erectile Function (IIEF) Questionnaire
IS - baseline to month 1
|
0.36 score on a scale
Standard Deviation 2.60
|
-0.01 score on a scale
Standard Deviation 1.59
|
|
Change in Quality of Life as Assessed by the International Index of Erectile Function (IIEF) Questionnaire
IS - baseline to month 3
|
1.55 score on a scale
Standard Deviation 4.83
|
0.05 score on a scale
Standard Deviation 1.66
|
|
Change in Quality of Life as Assessed by the International Index of Erectile Function (IIEF) Questionnaire
EF - baseline to month 3
|
2.65 score on a scale
Standard Deviation 6.46
|
0.05 score on a scale
Standard Deviation 2.86
|
|
Change in Quality of Life as Assessed by the International Index of Erectile Function (IIEF) Questionnaire
EF - baseline to month 6
|
2.36 score on a scale
Standard Deviation 6.30
|
0.65 score on a scale
Standard Deviation 3.75
|
|
Change in Quality of Life as Assessed by the International Index of Erectile Function (IIEF) Questionnaire
EF - baseline to month 12
|
2.5 score on a scale
Standard Deviation 6.95
|
0.05 score on a scale
Standard Deviation 1.32
|
|
Change in Quality of Life as Assessed by the International Index of Erectile Function (IIEF) Questionnaire
OF - baseline to month 1
|
0.91 score on a scale
Standard Deviation 2.39
|
0.25 score on a scale
Standard Deviation 1.13
|
|
Change in Quality of Life as Assessed by the International Index of Erectile Function (IIEF) Questionnaire
OF - baseline to month 3
|
1.93 score on a scale
Standard Deviation 2.99
|
-0.02 score on a scale
Standard Deviation 1.22
|
|
Change in Quality of Life as Assessed by the International Index of Erectile Function (IIEF) Questionnaire
OF - baseline to month 6
|
2.19 score on a scale
Standard Deviation 3.48
|
0.04 score on a scale
Standard Deviation 1.21
|
|
Change in Quality of Life as Assessed by the International Index of Erectile Function (IIEF) Questionnaire
OF - baseline to month 12
|
2.93 score on a scale
Standard Deviation 3.86
|
0.17 score on a scale
Standard Deviation 0.82
|
|
Change in Quality of Life as Assessed by the International Index of Erectile Function (IIEF) Questionnaire
SD - baseline to month 1
|
0.97 score on a scale
Standard Deviation 2.09
|
-0.27 score on a scale
Standard Deviation 1.55
|
|
Change in Quality of Life as Assessed by the International Index of Erectile Function (IIEF) Questionnaire
SD - baseline to month 3
|
1.85 score on a scale
Standard Deviation 2.70
|
0.10 score on a scale
Standard Deviation 1.51
|
|
Change in Quality of Life as Assessed by the International Index of Erectile Function (IIEF) Questionnaire
SD - baseline to month 12
|
2.38 score on a scale
Standard Deviation 2.31
|
0.30 score on a scale
Standard Deviation 1.49
|
|
Change in Quality of Life as Assessed by the International Index of Erectile Function (IIEF) Questionnaire
IS - baseline to month 6
|
0.74 score on a scale
Standard Deviation 4.18
|
0.08 score on a scale
Standard Deviation 1.94
|
|
Change in Quality of Life as Assessed by the International Index of Erectile Function (IIEF) Questionnaire
IS - baseline to month 12
|
2.40 score on a scale
Standard Deviation 4.73
|
0.00 score on a scale
Standard Deviation 0.00
|
|
Change in Quality of Life as Assessed by the International Index of Erectile Function (IIEF) Questionnaire
OS - baseline to month 1
|
0.65 score on a scale
Standard Deviation 2.23
|
0.17 score on a scale
Standard Deviation 1.94
|
|
Change in Quality of Life as Assessed by the International Index of Erectile Function (IIEF) Questionnaire
OS - baseline to month 3
|
1.13 score on a scale
Standard Deviation 2.70
|
0.25 score on a scale
Standard Deviation 1.71
|
|
Change in Quality of Life as Assessed by the International Index of Erectile Function (IIEF) Questionnaire
OS - baseline to month 6
|
0.60 score on a scale
Standard Deviation 3.09
|
-0.09 score on a scale
Standard Deviation 1.50
|
|
Change in Quality of Life as Assessed by the International Index of Erectile Function (IIEF) Questionnaire
OS - baseline to month 12
|
2.00 score on a scale
Standard Deviation 3.67
|
0.20 score on a scale
Standard Deviation 1.47
|
SECONDARY outcome
Timeframe: up to 1 yearPopulation: Questionnaires were not completed by all participants. Therefore, data was only collected from: Arm A- 89/94 at baseline, 84/94 at month 1, 74/94 at month 3, 55/94 at month 6 and 18/94 at month 12.Arm B- 96/101 at baseline, 86/101 at month 1, 81/101 at month 3, 56/101 at month 6 and 25/101 at month 12.
All questions are scored on a scale from 0 to 100. The total score from all of the questions answered is divided by the total number of the questions answered yielding a global score from 0-100 with 100 representing the highest level of functioning possible.
Outcome measures
| Measure |
Arm A: Testosterone Cypionate or Testosterone Enanthate
n=94 Participants
Patients on BAT will receive testosterone cypionate or testosterone enanthate administered as an intramuscular injection. A dose of 400 mg of either agent will be injected intramuscularly (IM) every 28 days.
Testosterone cypionate: Depo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. Depo-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.
Testosterone Enanthate: Testosterone Enanthate Injection, for intramuscular injection, contains testosterone enanthate which is the oil-soluble ester of the androgenic hormone testosterone. Enanthate Injection is available as a colorless to pale yellow solution. Each mL contains 200 mg testosterone enanthate in sesame oil with 5 mg chlorobutanol as a preservative.
|
Arm B: Enzalutamide
n=101 Participants
Patients randomized to enzalutamide will be prescribed enzalutamide 40 mg tablets and instructed to take 4 tablets per day orally for 28 days/cycle.
Enzalutamide: Enzalutamide is a white crystalline non-hygroscopic solid. It is practically insoluble in water. Enzalutamide is provided as liquid-filled soft gelatin capsules for oral administration. Each capsule contains 40 mg of enzalutamide as a solution in caprylocaproyl polyoxylglycerides. The inactive ingredients are caprylocaproyl polyoxylglycerides, butylated hydroxyanisole, butylated hydroxytoluene, gelatin, sorbitol sorbitan solution, glycerin, purified water, titanium dioxide, and black iron oxide.
|
|---|---|---|
|
Quality of Life as Assessed by Short Form 36
Baseline
|
63.16 score on a scale
Standard Deviation 12.7
|
61.89 score on a scale
Standard Deviation 11.9
|
|
Quality of Life as Assessed by Short Form 36
Month 1
|
61.68 score on a scale
Standard Deviation 11.7
|
56.94 score on a scale
Standard Deviation 13.6
|
|
Quality of Life as Assessed by Short Form 36
Month 3
|
62.34 score on a scale
Standard Deviation 13.8
|
55.34 score on a scale
Standard Deviation 15.1
|
|
Quality of Life as Assessed by Short Form 36
Month 6
|
63.49 score on a scale
Standard Deviation 13.3
|
58.67 score on a scale
Standard Deviation 13.6
|
|
Quality of Life as Assessed by Short Form 36
Month 12
|
67.35 score on a scale
Standard Deviation 9.45
|
59.65 score on a scale
Standard Deviation 14.9
|
SECONDARY outcome
Timeframe: up to 1 yearPopulation: Questionnaires were not completed by all participants. Therefore, data was only collected from: 84/94 at month 1, 76/94 at month 3, 55/94 at month 6 and 18/94 at month 12.Arm B- 87/101 at month 1, 81/101 at month 3, 56/101 at month 6 and 25/101 at month 12
The Functional Assessment of Chronic Illness Therapy - Fatigue has a score range of 0-52 with higher scores indicating better quality of life.
Outcome measures
| Measure |
Arm A: Testosterone Cypionate or Testosterone Enanthate
n=94 Participants
Patients on BAT will receive testosterone cypionate or testosterone enanthate administered as an intramuscular injection. A dose of 400 mg of either agent will be injected intramuscularly (IM) every 28 days.
Testosterone cypionate: Depo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. Depo-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.
Testosterone Enanthate: Testosterone Enanthate Injection, for intramuscular injection, contains testosterone enanthate which is the oil-soluble ester of the androgenic hormone testosterone. Enanthate Injection is available as a colorless to pale yellow solution. Each mL contains 200 mg testosterone enanthate in sesame oil with 5 mg chlorobutanol as a preservative.
|
Arm B: Enzalutamide
n=101 Participants
Patients randomized to enzalutamide will be prescribed enzalutamide 40 mg tablets and instructed to take 4 tablets per day orally for 28 days/cycle.
Enzalutamide: Enzalutamide is a white crystalline non-hygroscopic solid. It is practically insoluble in water. Enzalutamide is provided as liquid-filled soft gelatin capsules for oral administration. Each capsule contains 40 mg of enzalutamide as a solution in caprylocaproyl polyoxylglycerides. The inactive ingredients are caprylocaproyl polyoxylglycerides, butylated hydroxyanisole, butylated hydroxytoluene, gelatin, sorbitol sorbitan solution, glycerin, purified water, titanium dioxide, and black iron oxide.
|
|---|---|---|
|
Quality of Life as Assessed by FACIT Fatigue Scale
Month 3
|
38.39 score on a scale
Standard Deviation 11.1
|
33.51 score on a scale
Standard Deviation 11.8
|
|
Quality of Life as Assessed by FACIT Fatigue Scale
Month 1
|
38.13 score on a scale
Standard Deviation 9.85
|
32.60 score on a scale
Standard Deviation 12.0
|
|
Quality of Life as Assessed by FACIT Fatigue Scale
Month 6
|
39.23 score on a scale
Standard Deviation 11.4
|
34.51 score on a scale
Standard Deviation 11.3
|
|
Quality of Life as Assessed by FACIT Fatigue Scale
Month 12
|
41.67 score on a scale
Standard Deviation 8.39
|
34.58 score on a scale
Standard Deviation 13.5
|
SECONDARY outcome
Timeframe: 1 yearPopulation: For Arm A, the data was only collected from 85/94 at baseline, 78/94 at month 1, 67/94 at month 3, 54/94 at month 6, 17/94 at month 12. For Arm B, the data was only collected from 92/101 at baseline, 82/101 at month 1, 76/101 at month 3, 54/101 at month 6, 24/101 at month 12.
Severity is calculated by adding the scores for questions 2, 3, 4 and 5 and then dividing by 4. This gives a severity score out of 10, high score indicates more severe pain.
Outcome measures
| Measure |
Arm A: Testosterone Cypionate or Testosterone Enanthate
n=94 Participants
Patients on BAT will receive testosterone cypionate or testosterone enanthate administered as an intramuscular injection. A dose of 400 mg of either agent will be injected intramuscularly (IM) every 28 days.
Testosterone cypionate: Depo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. Depo-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.
Testosterone Enanthate: Testosterone Enanthate Injection, for intramuscular injection, contains testosterone enanthate which is the oil-soluble ester of the androgenic hormone testosterone. Enanthate Injection is available as a colorless to pale yellow solution. Each mL contains 200 mg testosterone enanthate in sesame oil with 5 mg chlorobutanol as a preservative.
|
Arm B: Enzalutamide
n=101 Participants
Patients randomized to enzalutamide will be prescribed enzalutamide 40 mg tablets and instructed to take 4 tablets per day orally for 28 days/cycle.
Enzalutamide: Enzalutamide is a white crystalline non-hygroscopic solid. It is practically insoluble in water. Enzalutamide is provided as liquid-filled soft gelatin capsules for oral administration. Each capsule contains 40 mg of enzalutamide as a solution in caprylocaproyl polyoxylglycerides. The inactive ingredients are caprylocaproyl polyoxylglycerides, butylated hydroxyanisole, butylated hydroxytoluene, gelatin, sorbitol sorbitan solution, glycerin, purified water, titanium dioxide, and black iron oxide.
|
|---|---|---|
|
Pain Severity as Assessed by the Brief Pain Inventory
Month 1
|
1.19 score on a scale
Standard Deviation 1.85
|
1.94 score on a scale
Standard Deviation 2.19
|
|
Pain Severity as Assessed by the Brief Pain Inventory
Month 12
|
0.76 score on a scale
Standard Deviation 1.39
|
1.13 score on a scale
Standard Deviation 1.87
|
|
Pain Severity as Assessed by the Brief Pain Inventory
Baseline
|
1.29 score on a scale
Standard Deviation 1.99
|
1.20 score on a scale
Standard Deviation 1.92
|
|
Pain Severity as Assessed by the Brief Pain Inventory
Month 3
|
1.67 score on a scale
Standard Deviation 2.06
|
1.62 score on a scale
Standard Deviation 2.05
|
|
Pain Severity as Assessed by the Brief Pain Inventory
Month 6
|
1.57 score on a scale
Standard Deviation 2.12
|
1.81 score on a scale
Standard Deviation 2.18
|
SECONDARY outcome
Timeframe: 1 yearPopulation: For Arm A, the data was only collected from 82/94 at baseline, 78/94 at month 1, 65/94 at month 3, 53/94 at month 6, 17/94 at month 12. For Arm B, the data was only collected from 91/101 at baseline, 81/101 at month 1, 76/101 at month 3, 55/101 at month 6, 25/101 at month 12.
Interference is calculated by adding the scores for questions 8a, b, c, d, e, f and g and then dividing by 7. This gives an interference score out of 10, higher score indicates more pain interference.
Outcome measures
| Measure |
Arm A: Testosterone Cypionate or Testosterone Enanthate
n=94 Participants
Patients on BAT will receive testosterone cypionate or testosterone enanthate administered as an intramuscular injection. A dose of 400 mg of either agent will be injected intramuscularly (IM) every 28 days.
Testosterone cypionate: Depo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. Depo-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.
Testosterone Enanthate: Testosterone Enanthate Injection, for intramuscular injection, contains testosterone enanthate which is the oil-soluble ester of the androgenic hormone testosterone. Enanthate Injection is available as a colorless to pale yellow solution. Each mL contains 200 mg testosterone enanthate in sesame oil with 5 mg chlorobutanol as a preservative.
|
Arm B: Enzalutamide
n=101 Participants
Patients randomized to enzalutamide will be prescribed enzalutamide 40 mg tablets and instructed to take 4 tablets per day orally for 28 days/cycle.
Enzalutamide: Enzalutamide is a white crystalline non-hygroscopic solid. It is practically insoluble in water. Enzalutamide is provided as liquid-filled soft gelatin capsules for oral administration. Each capsule contains 40 mg of enzalutamide as a solution in caprylocaproyl polyoxylglycerides. The inactive ingredients are caprylocaproyl polyoxylglycerides, butylated hydroxyanisole, butylated hydroxytoluene, gelatin, sorbitol sorbitan solution, glycerin, purified water, titanium dioxide, and black iron oxide.
|
|---|---|---|
|
Pain Interference as Assessed by the Brief Pain Inventory
Baseline
|
1.22 score on a scale
Standard Deviation 1.77
|
1.27 score on a scale
Standard Deviation 1.87
|
|
Pain Interference as Assessed by the Brief Pain Inventory
Month 1
|
1.55 score on a scale
Standard Deviation 2.00
|
2.26 score on a scale
Standard Deviation 2.52
|
|
Pain Interference as Assessed by the Brief Pain Inventory
Month 3
|
2.00 score on a scale
Standard Deviation 2.20
|
1.94 score on a scale
Standard Deviation 2.26
|
|
Pain Interference as Assessed by the Brief Pain Inventory
Month 6
|
1.96 score on a scale
Standard Deviation 2.59
|
1.84 score on a scale
Standard Deviation 2.07
|
|
Pain Interference as Assessed by the Brief Pain Inventory
Month 12
|
1.04 score on a scale
Standard Deviation 1.85
|
1.70 score on a scale
Standard Deviation 2.39
|
SECONDARY outcome
Timeframe: up to 3 yearsTime until death for any reasons
Outcome measures
| Measure |
Arm A: Testosterone Cypionate or Testosterone Enanthate
n=94 Participants
Patients on BAT will receive testosterone cypionate or testosterone enanthate administered as an intramuscular injection. A dose of 400 mg of either agent will be injected intramuscularly (IM) every 28 days.
Testosterone cypionate: Depo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. Depo-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.
Testosterone Enanthate: Testosterone Enanthate Injection, for intramuscular injection, contains testosterone enanthate which is the oil-soluble ester of the androgenic hormone testosterone. Enanthate Injection is available as a colorless to pale yellow solution. Each mL contains 200 mg testosterone enanthate in sesame oil with 5 mg chlorobutanol as a preservative.
|
Arm B: Enzalutamide
n=101 Participants
Patients randomized to enzalutamide will be prescribed enzalutamide 40 mg tablets and instructed to take 4 tablets per day orally for 28 days/cycle.
Enzalutamide: Enzalutamide is a white crystalline non-hygroscopic solid. It is practically insoluble in water. Enzalutamide is provided as liquid-filled soft gelatin capsules for oral administration. Each capsule contains 40 mg of enzalutamide as a solution in caprylocaproyl polyoxylglycerides. The inactive ingredients are caprylocaproyl polyoxylglycerides, butylated hydroxyanisole, butylated hydroxytoluene, gelatin, sorbitol sorbitan solution, glycerin, purified water, titanium dioxide, and black iron oxide.
|
|---|---|---|
|
Overall Survival
|
32.9 months
Interval 28.2 to 37.3
|
29 months
Interval 26.2 to 35.5
|
SECONDARY outcome
Timeframe: up to 2 yearsTime from initiation of therapy to progression on crossover treatment
Outcome measures
| Measure |
Arm A: Testosterone Cypionate or Testosterone Enanthate
n=94 Participants
Patients on BAT will receive testosterone cypionate or testosterone enanthate administered as an intramuscular injection. A dose of 400 mg of either agent will be injected intramuscularly (IM) every 28 days.
Testosterone cypionate: Depo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. Depo-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.
Testosterone Enanthate: Testosterone Enanthate Injection, for intramuscular injection, contains testosterone enanthate which is the oil-soluble ester of the androgenic hormone testosterone. Enanthate Injection is available as a colorless to pale yellow solution. Each mL contains 200 mg testosterone enanthate in sesame oil with 5 mg chlorobutanol as a preservative.
|
Arm B: Enzalutamide
n=101 Participants
Patients randomized to enzalutamide will be prescribed enzalutamide 40 mg tablets and instructed to take 4 tablets per day orally for 28 days/cycle.
Enzalutamide: Enzalutamide is a white crystalline non-hygroscopic solid. It is practically insoluble in water. Enzalutamide is provided as liquid-filled soft gelatin capsules for oral administration. Each capsule contains 40 mg of enzalutamide as a solution in caprylocaproyl polyoxylglycerides. The inactive ingredients are caprylocaproyl polyoxylglycerides, butylated hydroxyanisole, butylated hydroxytoluene, gelatin, sorbitol sorbitan solution, glycerin, purified water, titanium dioxide, and black iron oxide.
|
|---|---|---|
|
Progression Free Survival on Crossover Treatment
|
28.2 months
Interval 23.6 to
Not reached
|
19.6 months
Interval 12.9 to 29.7
|
Adverse Events
Arm A: Testosterone Cypionate or Testosterone Enanthate
Serious events: 4 serious events
Other events: 22 other events
Deaths: 0 deaths
Arm B: Enzalutamide
Serious events: 11 serious events
Other events: 29 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Arm A: Testosterone Cypionate or Testosterone Enanthate
n=94 participants at risk
Patients on BAT will receive testosterone cypionate or testosterone enanthate administered as an intramuscular injection. A dose of 400 mg of either agent will be injected intramuscularly (IM) every 28 days.
Testosterone cypionate: Depo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. Depo-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.
Testosterone Enanthate: Testosterone Enanthate Injection, for intramuscular injection, contains testosterone enanthate which is the oil-soluble ester of the androgenic hormone testosterone. Enanthate Injection is available as a colorless to pale yellow solution. Each mL contains 200 mg testosterone enanthate in sesame oil with 5 mg chlorobutanol as a preservative.
|
Arm B: Enzalutamide
n=101 participants at risk
Patients randomized to enzalutamide will be prescribed enzalutamide 40 mg tablets and instructed to take 4 tablets per day orally for 28 days/cycle.
Enzalutamide: Enzalutamide is a white crystalline non-hygroscopic solid. It is practically insoluble in water. Enzalutamide is provided as liquid-filled soft gelatin capsules for oral administration. Each capsule contains 40 mg of enzalutamide as a solution in caprylocaproyl polyoxylglycerides. The inactive ingredients are caprylocaproyl polyoxylglycerides, butylated hydroxyanisole, butylated hydroxytoluene, gelatin, sorbitol sorbitan solution, glycerin, purified water, titanium dioxide, and black iron oxide.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.1%
1/94 • Number of events 1 • up to 2 years
|
0.00%
0/101 • up to 2 years
|
|
Nervous system disorders
Stroke
|
1.1%
1/94 • Number of events 1 • up to 2 years
|
0.00%
0/101 • up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.1%
2/94 • Number of events 2 • up to 2 years
|
5.9%
6/101 • Number of events 6 • up to 2 years
|
|
Nervous system disorders
Seizure
|
0.00%
0/94 • up to 2 years
|
0.99%
1/101 • Number of events 1 • up to 2 years
|
|
Cardiac disorders
myocardial infarction
|
0.00%
0/94 • up to 2 years
|
0.99%
1/101 • Number of events 2 • up to 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/94 • up to 2 years
|
0.99%
1/101 • Number of events 1 • up to 2 years
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/94 • up to 2 years
|
0.99%
1/101 • Number of events 1 • up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/94 • up to 2 years
|
0.99%
1/101 • Number of events 1 • up to 2 years
|
Other adverse events
| Measure |
Arm A: Testosterone Cypionate or Testosterone Enanthate
n=94 participants at risk
Patients on BAT will receive testosterone cypionate or testosterone enanthate administered as an intramuscular injection. A dose of 400 mg of either agent will be injected intramuscularly (IM) every 28 days.
Testosterone cypionate: Depo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. Depo-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.
Testosterone Enanthate: Testosterone Enanthate Injection, for intramuscular injection, contains testosterone enanthate which is the oil-soluble ester of the androgenic hormone testosterone. Enanthate Injection is available as a colorless to pale yellow solution. Each mL contains 200 mg testosterone enanthate in sesame oil with 5 mg chlorobutanol as a preservative.
|
Arm B: Enzalutamide
n=101 participants at risk
Patients randomized to enzalutamide will be prescribed enzalutamide 40 mg tablets and instructed to take 4 tablets per day orally for 28 days/cycle.
Enzalutamide: Enzalutamide is a white crystalline non-hygroscopic solid. It is practically insoluble in water. Enzalutamide is provided as liquid-filled soft gelatin capsules for oral administration. Each capsule contains 40 mg of enzalutamide as a solution in caprylocaproyl polyoxylglycerides. The inactive ingredients are caprylocaproyl polyoxylglycerides, butylated hydroxyanisole, butylated hydroxytoluene, gelatin, sorbitol sorbitan solution, glycerin, purified water, titanium dioxide, and black iron oxide.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
5.3%
5/94 • Number of events 5 • up to 2 years
|
5.9%
6/101 • Number of events 6 • up to 2 years
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders
|
3.2%
3/94 • Number of events 3 • up to 2 years
|
5.9%
6/101 • Number of events 6 • up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.4%
6/94 • Number of events 6 • up to 2 years
|
7.9%
8/101 • Number of events 8 • up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.1%
2/94 • Number of events 2 • up to 2 years
|
7.9%
8/101 • Number of events 8 • up to 2 years
|
|
General disorders
fatigue
|
11.7%
11/94 • Number of events 11 • up to 2 years
|
3.0%
3/101 • Number of events 3 • up to 2 years
|
|
General disorders
pain
|
4.3%
4/94 • Number of events 4 • up to 2 years
|
8.9%
9/101 • Number of events 9 • up to 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place