Trial Outcomes & Findings for Trial of Radiotherapy With Leuprolide and Enzalutamide in High Risk Prostate Cancer (NCT NCT02508636)
NCT ID: NCT02508636
Last Updated: 2021-10-12
Results Overview
Percentage of participants with acute, treatment-related toxicity defined as \<=90 days within the completion of radiotherapy, for any treatment-related grade 3 or higher adverse events as classified by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
TERMINATED
PHASE2
11 participants
From start of treatment to 90 days after completion of radiotherapy, approximately 6 months total
2021-10-12
Participant Flow
Participant milestones
| Measure |
Combination Therapy: Enzalutamide and Leuprolide
Participants will receive Enzalutamide: 160 mg per day, to begin within 0-7 days of the date of the first Luteinizing Hormone-Releasing Hormone (LHRH) agonist administration for total duration of 24 months as well as a single Leuprolide 7.5mg injection every month; single 22.5 mg injection every 3 months; single 30mg injection every 4 months; single 45 mg injection every 6-months based on the manufacturer for a total of 24 months.
Radiation therapy should begin approximately 8 weeks (+/- 1 week) after the date of the first LHRH agonist/antagonist injection of hormone therapy is given and continue for a total of 5 weeks.
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|---|---|
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Overall Study
STARTED
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11
|
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Overall Study
COMPLETED
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11
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of Radiotherapy With Leuprolide and Enzalutamide in High Risk Prostate Cancer
Baseline characteristics by cohort
| Measure |
Combination Therapy: Enzalutamide and Leuprolide
n=11 Participants
Participants will receive Enzalutamide: 160 mg per day, to begin within 0-7 days of the date of the first Luteinizing Hormone-Releasing Hormone (LHRH) agonist administration for total duration of 24 months as well as a single Leuprolide 7.5mg injection every month; single 22.5 mg injection every 3 months; single 30mg injection every 4 months; single 45 mg injection every 6-months based on the manufacturer for a total of 24 months.
Radiation therapy should begin approximately 8 weeks (+/- 1 week) after the date of the first LHRH agonist/antagonist injection of hormone therapy is given and continue for a total of 5 weeks.
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|---|---|
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Age, Continuous
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69.0 years
n=5 Participants
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Sex: Female, Male
Female
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0 Participants
n=5 Participants
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Sex: Female, Male
Male
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11 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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11 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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2 Participants
n=5 Participants
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Race (NIH/OMB)
White
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6 Participants
n=5 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Unknown or Not Reported
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2 Participants
n=5 Participants
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Region of Enrollment
United States
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11 participants
n=5 Participants
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Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status
Score of 0
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9 participants
n=5 Participants
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Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status
Score of 1
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2 participants
n=5 Participants
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Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status
Score of 2
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0 participants
n=5 Participants
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PRIMARY outcome
Timeframe: From start of treatment to 90 days after completion of radiotherapy, approximately 6 months totalPercentage of participants with acute, treatment-related toxicity defined as \<=90 days within the completion of radiotherapy, for any treatment-related grade 3 or higher adverse events as classified by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Outcome measures
| Measure |
Combination Therapy: Enzalutamide and Leuprolide
n=11 Participants
Participants will receive Enzalutamide: 160 mg per day, to begin within 0-7 days of the date of the first Luteinizing Hormone-Releasing Hormone (LHRH) agonist administration for total duration of 24 months as well as a single Leuprolide 7.5mg injection every month; single 22.5 mg injection every 3 months; single 30mg injection every 4 months; single 45 mg injection every 6-months based on the manufacturer for a total of 24 months.
Radiation therapy should begin approximately 8 weeks (+/- 1 week) after the date of the first LHRH agonist/antagonist injection of hormone therapy is given and continue for a total of 5 weeks.
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|---|---|
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Percentage of Participants With Acute Treatment-related Toxicity
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36.36 percentage of participants
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PRIMARY outcome
Timeframe: From 90 days after completion of radiotherapy until end of study, approximately 30 months totalPercentage of participants with late, treatment-related, toxicity is defined as any toxicity occurring \>= 90 days from completion of radiotherapy for any grade 3 or higher treatment-related adverse events as classified by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Outcome measures
| Measure |
Combination Therapy: Enzalutamide and Leuprolide
n=11 Participants
Participants will receive Enzalutamide: 160 mg per day, to begin within 0-7 days of the date of the first Luteinizing Hormone-Releasing Hormone (LHRH) agonist administration for total duration of 24 months as well as a single Leuprolide 7.5mg injection every month; single 22.5 mg injection every 3 months; single 30mg injection every 4 months; single 45 mg injection every 6-months based on the manufacturer for a total of 24 months.
Radiation therapy should begin approximately 8 weeks (+/- 1 week) after the date of the first LHRH agonist/antagonist injection of hormone therapy is given and continue for a total of 5 weeks.
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|---|---|
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Percentage of Participants With Late Treatment-related Toxicity
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27.27 percentage of participants
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PRIMARY outcome
Timeframe: Up to 127 daysA PSA measurement will be obtained at 120-127 days after initiation of androgen deprivation therapy. The proportion of patients achieving a PSA-CR (PSA nadir \<=0.3) at 120-127 days will be determined.
Outcome measures
| Measure |
Combination Therapy: Enzalutamide and Leuprolide
n=11 Participants
Participants will receive Enzalutamide: 160 mg per day, to begin within 0-7 days of the date of the first Luteinizing Hormone-Releasing Hormone (LHRH) agonist administration for total duration of 24 months as well as a single Leuprolide 7.5mg injection every month; single 22.5 mg injection every 3 months; single 30mg injection every 4 months; single 45 mg injection every 6-months based on the manufacturer for a total of 24 months.
Radiation therapy should begin approximately 8 weeks (+/- 1 week) after the date of the first LHRH agonist/antagonist injection of hormone therapy is given and continue for a total of 5 weeks.
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|---|---|
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Proportion of Patients Achieving a Prostate Specific Antigen-Complete Response (PSA-CR)
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0.818 proportion of participants
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SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: Only participants experiencing biochemical failure are reported
Prostate-specific antigen (PSA) nadir \>=2 ng/mL, also known as the Phoenix definition, is the definition most commonly used to establish biochemical failure (BF) after external beam radiotherapy for prostate cancer management. Time to biochemical failure is defined as the time from start of treatment to the time of change in PSA \>=2 ng/mL from the nadir.
Outcome measures
| Measure |
Combination Therapy: Enzalutamide and Leuprolide
n=1 Participants
Participants will receive Enzalutamide: 160 mg per day, to begin within 0-7 days of the date of the first Luteinizing Hormone-Releasing Hormone (LHRH) agonist administration for total duration of 24 months as well as a single Leuprolide 7.5mg injection every month; single 22.5 mg injection every 3 months; single 30mg injection every 4 months; single 45 mg injection every 6-months based on the manufacturer for a total of 24 months.
Radiation therapy should begin approximately 8 weeks (+/- 1 week) after the date of the first LHRH agonist/antagonist injection of hormone therapy is given and continue for a total of 5 weeks.
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Median Time to Biochemical Failure
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36 months
Only 1 participant had biochemical failure at 36 months so there were not a sufficient number of events for a confidence interval to be computed
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SECONDARY outcome
Timeframe: Up to 36 monthsLocal failure was defined as the time from the start of treatment to a biopsy confirmed disease recurrence.
Outcome measures
| Measure |
Combination Therapy: Enzalutamide and Leuprolide
n=11 Participants
Participants will receive Enzalutamide: 160 mg per day, to begin within 0-7 days of the date of the first Luteinizing Hormone-Releasing Hormone (LHRH) agonist administration for total duration of 24 months as well as a single Leuprolide 7.5mg injection every month; single 22.5 mg injection every 3 months; single 30mg injection every 4 months; single 45 mg injection every 6-months based on the manufacturer for a total of 24 months.
Radiation therapy should begin approximately 8 weeks (+/- 1 week) after the date of the first LHRH agonist/antagonist injection of hormone therapy is given and continue for a total of 5 weeks.
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|---|---|
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Median Time to Local Failure
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NA months
No participants displayed local failure at 36 months so there were not a sufficient number of events for a confidence interval to be computed
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SECONDARY outcome
Timeframe: Up to 36 monthsThe number of participants with confirmed regional or distant metastases at 24 and 36 months will be reported.
Outcome measures
| Measure |
Combination Therapy: Enzalutamide and Leuprolide
n=11 Participants
Participants will receive Enzalutamide: 160 mg per day, to begin within 0-7 days of the date of the first Luteinizing Hormone-Releasing Hormone (LHRH) agonist administration for total duration of 24 months as well as a single Leuprolide 7.5mg injection every month; single 22.5 mg injection every 3 months; single 30mg injection every 4 months; single 45 mg injection every 6-months based on the manufacturer for a total of 24 months.
Radiation therapy should begin approximately 8 weeks (+/- 1 week) after the date of the first LHRH agonist/antagonist injection of hormone therapy is given and continue for a total of 5 weeks.
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|---|---|
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Number of Participants With Regional or Distant Metastases Over Time
Month 24
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0 Participants
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Number of Participants With Regional or Distant Metastases Over Time
Month 36
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0 Participants
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SECONDARY outcome
Timeframe: Up to 36 monthsDefined as the time from the start of study treatment to confirmed regional or distant metastases
Outcome measures
| Measure |
Combination Therapy: Enzalutamide and Leuprolide
n=11 Participants
Participants will receive Enzalutamide: 160 mg per day, to begin within 0-7 days of the date of the first Luteinizing Hormone-Releasing Hormone (LHRH) agonist administration for total duration of 24 months as well as a single Leuprolide 7.5mg injection every month; single 22.5 mg injection every 3 months; single 30mg injection every 4 months; single 45 mg injection every 6-months based on the manufacturer for a total of 24 months.
Radiation therapy should begin approximately 8 weeks (+/- 1 week) after the date of the first LHRH agonist/antagonist injection of hormone therapy is given and continue for a total of 5 weeks.
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|---|---|
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Median Time to Clinical Progression
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NA months
No participants displayed clinical progression so there was an insufficient number of events to calculate median and confidence interval
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SECONDARY outcome
Timeframe: Up to 24 monthsHbA1C test results are reported as a percentage. The higher the percentage, the higher your blood sugar levels over the past two to three months. Changes in HbA1c results will be assessed during treatment and the overall median change in HbA1c will be reported.
Outcome measures
| Measure |
Combination Therapy: Enzalutamide and Leuprolide
n=11 Participants
Participants will receive Enzalutamide: 160 mg per day, to begin within 0-7 days of the date of the first Luteinizing Hormone-Releasing Hormone (LHRH) agonist administration for total duration of 24 months as well as a single Leuprolide 7.5mg injection every month; single 22.5 mg injection every 3 months; single 30mg injection every 4 months; single 45 mg injection every 6-months based on the manufacturer for a total of 24 months.
Radiation therapy should begin approximately 8 weeks (+/- 1 week) after the date of the first LHRH agonist/antagonist injection of hormone therapy is given and continue for a total of 5 weeks.
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|---|---|
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Overall Median Change in Hemoglobin A1c (HbA1c) Levels During Treatment
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0.2 percentage
Interval -1.1 to 1.5
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SECONDARY outcome
Timeframe: Up to 24 monthsChanges in fasting glucose levels results will be assessed during treatment and the overall median change in fasting glucose levels will be reported.
Outcome measures
| Measure |
Combination Therapy: Enzalutamide and Leuprolide
n=11 Participants
Participants will receive Enzalutamide: 160 mg per day, to begin within 0-7 days of the date of the first Luteinizing Hormone-Releasing Hormone (LHRH) agonist administration for total duration of 24 months as well as a single Leuprolide 7.5mg injection every month; single 22.5 mg injection every 3 months; single 30mg injection every 4 months; single 45 mg injection every 6-months based on the manufacturer for a total of 24 months.
Radiation therapy should begin approximately 8 weeks (+/- 1 week) after the date of the first LHRH agonist/antagonist injection of hormone therapy is given and continue for a total of 5 weeks.
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|---|---|
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Overall Median Change in Fasting Glucose Levels During Treatment
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-2.7 mg/dL
Interval -20.0 to 19.0
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SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Data for fasting insulin was not collected
Changes in fasting insulin levels will be assessed during treatment and the overall median change in fasting insulin levels will be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsChanges in fasting lipid levels will be assessed during treatment and the overall median change in fasting lipid levels will be reported.
Outcome measures
| Measure |
Combination Therapy: Enzalutamide and Leuprolide
n=11 Participants
Participants will receive Enzalutamide: 160 mg per day, to begin within 0-7 days of the date of the first Luteinizing Hormone-Releasing Hormone (LHRH) agonist administration for total duration of 24 months as well as a single Leuprolide 7.5mg injection every month; single 22.5 mg injection every 3 months; single 30mg injection every 4 months; single 45 mg injection every 6-months based on the manufacturer for a total of 24 months.
Radiation therapy should begin approximately 8 weeks (+/- 1 week) after the date of the first LHRH agonist/antagonist injection of hormone therapy is given and continue for a total of 5 weeks.
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|---|---|
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Overall Median Change in Lipid Levels During Treatment
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0 mg/dL
Interval -101.0 to 86.0
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SECONDARY outcome
Timeframe: Up to 24 monthsChanges in total cholesterol levels will be assessed during treatment and the overall median change in total cholesterol levels will be reported.
Outcome measures
| Measure |
Combination Therapy: Enzalutamide and Leuprolide
n=11 Participants
Participants will receive Enzalutamide: 160 mg per day, to begin within 0-7 days of the date of the first Luteinizing Hormone-Releasing Hormone (LHRH) agonist administration for total duration of 24 months as well as a single Leuprolide 7.5mg injection every month; single 22.5 mg injection every 3 months; single 30mg injection every 4 months; single 45 mg injection every 6-months based on the manufacturer for a total of 24 months.
Radiation therapy should begin approximately 8 weeks (+/- 1 week) after the date of the first LHRH agonist/antagonist injection of hormone therapy is given and continue for a total of 5 weeks.
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|---|---|
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Overall Median Change in Total Cholesterol Levels During Treatment
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12 mg/dL
Interval -270.0 to 86.0
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SECONDARY outcome
Timeframe: Up to 24 monthsChanges in fasting HDL levels will be assessed during treatment and the overall median change in fasting HDL will be reported.
Outcome measures
| Measure |
Combination Therapy: Enzalutamide and Leuprolide
n=11 Participants
Participants will receive Enzalutamide: 160 mg per day, to begin within 0-7 days of the date of the first Luteinizing Hormone-Releasing Hormone (LHRH) agonist administration for total duration of 24 months as well as a single Leuprolide 7.5mg injection every month; single 22.5 mg injection every 3 months; single 30mg injection every 4 months; single 45 mg injection every 6-months based on the manufacturer for a total of 24 months.
Radiation therapy should begin approximately 8 weeks (+/- 1 week) after the date of the first LHRH agonist/antagonist injection of hormone therapy is given and continue for a total of 5 weeks.
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|---|---|
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Overall Median Change in High-Density Lipoprotein (HDL) Cholesterol Levels During Treatment
|
12 mg/dL
Interval -18.0 to 105.0
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SECONDARY outcome
Timeframe: Up to 24 monthsChanges in fasting LDL levels will be assessed during treatment and the overall median change in fasting LDL will be reported.
Outcome measures
| Measure |
Combination Therapy: Enzalutamide and Leuprolide
n=11 Participants
Participants will receive Enzalutamide: 160 mg per day, to begin within 0-7 days of the date of the first Luteinizing Hormone-Releasing Hormone (LHRH) agonist administration for total duration of 24 months as well as a single Leuprolide 7.5mg injection every month; single 22.5 mg injection every 3 months; single 30mg injection every 4 months; single 45 mg injection every 6-months based on the manufacturer for a total of 24 months.
Radiation therapy should begin approximately 8 weeks (+/- 1 week) after the date of the first LHRH agonist/antagonist injection of hormone therapy is given and continue for a total of 5 weeks.
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|---|---|
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Overall Median Change in Low-Density Lipoprotein (LDL) Cholesterol Levels During Treatment
|
0 mg/dL
Interval -201.0 to 81.0
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SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Two participants did not complete the questionnaire
The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment and assesses the disease-specific aspects of prostate cancer and its therapies and comprises four summary domains (Urinary, Bowel, Sexual and Hormonal). Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life. Changes in EPIC scores will be assessed during treatment and the overall median change in scores will be reported.
Outcome measures
| Measure |
Combination Therapy: Enzalutamide and Leuprolide
n=9 Participants
Participants will receive Enzalutamide: 160 mg per day, to begin within 0-7 days of the date of the first Luteinizing Hormone-Releasing Hormone (LHRH) agonist administration for total duration of 24 months as well as a single Leuprolide 7.5mg injection every month; single 22.5 mg injection every 3 months; single 30mg injection every 4 months; single 45 mg injection every 6-months based on the manufacturer for a total of 24 months.
Radiation therapy should begin approximately 8 weeks (+/- 1 week) after the date of the first LHRH agonist/antagonist injection of hormone therapy is given and continue for a total of 5 weeks.
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|---|---|
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Overall Median Change in Score on the Expanded Prostate Cancer Index Composite (EPIC) During Treatment
Urinary incontinence
|
6.25 score on a scale
Interval -20.8 to 25.0
|
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Overall Median Change in Score on the Expanded Prostate Cancer Index Composite (EPIC) During Treatment
Urinary Irritative/Obstructive
|
6.25 score on a scale
Interval -6.25 to 25.0
|
|
Overall Median Change in Score on the Expanded Prostate Cancer Index Composite (EPIC) During Treatment
Bowel
|
0 score on a scale
Interval -20.8 to 4.2
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Overall Median Change in Score on the Expanded Prostate Cancer Index Composite (EPIC) During Treatment
Sexual
|
-44.4 score on a scale
Interval -56.9 to 0.0
|
|
Overall Median Change in Score on the Expanded Prostate Cancer Index Composite (EPIC) During Treatment
Hormonal
|
-20 score on a scale
Interval -75.0 to 5.0
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Two participants did not complete the questionnaire
A PROMIS score of 50 is the average (or mean) score for a specific, relevant group of people under investigation. That group is the reference population. The PROMIS measures the responses use a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. A score of 40 is one SD lower than the mean of the reference population and a score of 60 is one SD higher than the mean of the reference population. For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue). Changes in the PROMIS fatigue scores will be assessed during treatment and the overall median change in scores will be reported.
Outcome measures
| Measure |
Combination Therapy: Enzalutamide and Leuprolide
n=9 Participants
Participants will receive Enzalutamide: 160 mg per day, to begin within 0-7 days of the date of the first Luteinizing Hormone-Releasing Hormone (LHRH) agonist administration for total duration of 24 months as well as a single Leuprolide 7.5mg injection every month; single 22.5 mg injection every 3 months; single 30mg injection every 4 months; single 45 mg injection every 6-months based on the manufacturer for a total of 24 months.
Radiation therapy should begin approximately 8 weeks (+/- 1 week) after the date of the first LHRH agonist/antagonist injection of hormone therapy is given and continue for a total of 5 weeks.
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|---|---|
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Overall Median Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Fatigue Scores During Treatment
|
0 score on a scale
Interval -9.6 to 21.5
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SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Two participants did not complete the questionnaire
EQ-5D is a standardized instrument for measuring generic health status. The health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The respondents self-rate their level of severity for each dimension by selecting one of the following responses: no problems (0), slight problems (1), mild problems (2), moderate problems (3), or severe problems (4) with a particular dimension. Lower scores indicate less issues/problems with that particular health dimension. Changes in the EQ-5D scores will be assessed during treatment and the overall median change in scores will be reported.
Outcome measures
| Measure |
Combination Therapy: Enzalutamide and Leuprolide
n=9 Participants
Participants will receive Enzalutamide: 160 mg per day, to begin within 0-7 days of the date of the first Luteinizing Hormone-Releasing Hormone (LHRH) agonist administration for total duration of 24 months as well as a single Leuprolide 7.5mg injection every month; single 22.5 mg injection every 3 months; single 30mg injection every 4 months; single 45 mg injection every 6-months based on the manufacturer for a total of 24 months.
Radiation therapy should begin approximately 8 weeks (+/- 1 week) after the date of the first LHRH agonist/antagonist injection of hormone therapy is given and continue for a total of 5 weeks.
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|---|---|
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Overall Median Change in EuroQol Group Five Dimensional Questionnaire (EQ-5D) During Treatment
Mobility
|
0 score on a scale
Interval 0.0 to 1.0
|
|
Overall Median Change in EuroQol Group Five Dimensional Questionnaire (EQ-5D) During Treatment
Self-Care
|
0 score on a scale
Interval 0.0 to 1.0
|
|
Overall Median Change in EuroQol Group Five Dimensional Questionnaire (EQ-5D) During Treatment
Usual Activities
|
0 score on a scale
Interval 0.0 to 1.0
|
|
Overall Median Change in EuroQol Group Five Dimensional Questionnaire (EQ-5D) During Treatment
Pain/Discomfort
|
0 score on a scale
Interval 0.0 to 2.0
|
|
Overall Median Change in EuroQol Group Five Dimensional Questionnaire (EQ-5D) During Treatment
Anxiety/Depression
|
0 score on a scale
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Two participants did not complete the questionnaire
The EQ-VAS records the patient's self-rated health on a vertical visual analogue scale, similar to a ruler, where the endpoints are labelled with 100='The best health you can imagine' on one end and 0='The worst health you can imagine' on the other, with 50 being the midpoint and participants mark an X on the scale to indicate how their health is on the day of the visit. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement. Changes in the EQ-VAS scores will be assessed during treatment and the overall median change in scores will be reported.
Outcome measures
| Measure |
Combination Therapy: Enzalutamide and Leuprolide
n=9 Participants
Participants will receive Enzalutamide: 160 mg per day, to begin within 0-7 days of the date of the first Luteinizing Hormone-Releasing Hormone (LHRH) agonist administration for total duration of 24 months as well as a single Leuprolide 7.5mg injection every month; single 22.5 mg injection every 3 months; single 30mg injection every 4 months; single 45 mg injection every 6-months based on the manufacturer for a total of 24 months.
Radiation therapy should begin approximately 8 weeks (+/- 1 week) after the date of the first LHRH agonist/antagonist injection of hormone therapy is given and continue for a total of 5 weeks.
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|---|---|
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Overall Median Change in EuroQol Group Visual Analog Scale (EQ-VAS) During Treatment
|
72 score on a scale
Interval -2.0 to 81.0
|
Adverse Events
Combination Therapy: Enzalutamide and Leuprolide
Serious adverse events
| Measure |
Combination Therapy: Enzalutamide and Leuprolide
n=11 participants at risk
Enzalutamide: 160 mg (for 40 mg capsules) per day; Oral administration to begin within 0-7 days of the date of the first Luteinizing Hormone-Releasing Hormone (LHRH) agonist administration for total duration of 24 months.
Leuprolide: any duration formulation: single 7.5mg intramuscular injection every month; single 22.5 mg injection every 3 months; single 30mg injection every 4 months; single 45 mg injection every 6-months based on the manufacturer for a total of 24 months;
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|---|---|
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Nervous system disorders
Seizure
|
9.1%
1/11 • Number of events 1 • Up to 3 years
|
Other adverse events
| Measure |
Combination Therapy: Enzalutamide and Leuprolide
n=11 participants at risk
Enzalutamide: 160 mg (for 40 mg capsules) per day; Oral administration to begin within 0-7 days of the date of the first Luteinizing Hormone-Releasing Hormone (LHRH) agonist administration for total duration of 24 months.
Leuprolide: any duration formulation: single 7.5mg intramuscular injection every month; single 22.5 mg injection every 3 months; single 30mg injection every 4 months; single 45 mg injection every 6-months based on the manufacturer for a total of 24 months;
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|---|---|
|
Renal and urinary disorders
Urinary frequency
|
100.0%
11/11 • Number of events 40 • Up to 3 years
|
|
Renal and urinary disorders
Urinary urgency
|
90.9%
10/11 • Number of events 15 • Up to 3 years
|
|
Renal and urinary disorders
Urinary retention
|
36.4%
4/11 • Number of events 5 • Up to 3 years
|
|
Renal and urinary disorders
Urinary incontinence
|
27.3%
3/11 • Number of events 4 • Up to 3 years
|
|
Renal and urinary disorders
Cystitis noninfective
|
18.2%
2/11 • Number of events 2 • Up to 3 years
|
|
Renal and urinary disorders
Chronic kidney disease
|
9.1%
1/11 • Number of events 1 • Up to 3 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
9.1%
1/11 • Number of events 2 • Up to 3 years
|
|
Vascular disorders
Hot flashes
|
100.0%
11/11 • Number of events 13 • Up to 3 years
|
|
Vascular disorders
Lymphedema
|
18.2%
2/11 • Number of events 2 • Up to 3 years
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
81.8%
9/11 • Number of events 12 • Up to 3 years
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other
|
9.1%
1/11 • Number of events 2 • Up to 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
27.3%
3/11 • Number of events 5 • Up to 3 years
|
|
Gastrointestinal disorders
Constipation
|
9.1%
1/11 • Number of events 1 • Up to 3 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
9.1%
1/11 • Number of events 1 • Up to 3 years
|
|
Gastrointestinal disorders
Proctitis
|
9.1%
1/11 • Number of events 1 • Up to 3 years
|
|
Investigations
Weight gain
|
18.2%
2/11 • Number of events 2 • Up to 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
9.1%
1/11 • Number of events 1 • Up to 3 years
|
|
Investigations
Creatinine increased
|
9.1%
1/11 • Number of events 1 • Up to 3 years
|
|
Investigations
Weight loss
|
9.1%
1/11 • Number of events 1 • Up to 3 years
|
|
Nervous system disorders
Cognitive disturbance
|
18.2%
2/11 • Number of events 2 • Up to 3 years
|
|
Nervous system disorders
Dysgeusia
|
9.1%
1/11 • Number of events 1 • Up to 3 years
|
|
Nervous system disorders
Headache
|
9.1%
1/11 • Number of events 1 • Up to 3 years
|
|
General disorders
Fatigue
|
18.2%
2/11 • Number of events 3 • Up to 3 years
|
|
General disorders
General disorders and administration site conditions - Other
|
9.1%
1/11 • Number of events 1 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
18.2%
2/11 • Number of events 2 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.1%
1/11 • Number of events 1 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.1%
1/11 • Number of events 1 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
9.1%
1/11 • Number of events 1 • Up to 3 years
|
|
Infections and infestations
Urinary tract infection
|
9.1%
1/11 • Number of events 1 • Up to 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
9.1%
1/11 • Number of events 1 • Up to 3 years
|
|
Psychiatric disorders
Libido decreased
|
9.1%
1/11 • Number of events 1 • Up to 3 years
|
Additional Information
Dr. Hao Nguyen
University of California, San Francisco
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place