Trial Outcomes & Findings for A Phase II Study of Increased-Dose Abiraterone Acetate in Patients With Castration Resistant Prostate Cancer (NCT NCT01637402)
NCT ID: NCT01637402
Last Updated: 2020-08-17
Results Overview
A PSA response for the dose escalation group is defined as a participant with a documented PSA decline after 12 weeks of therapy with standard-dose, then had disease progression, and then achieved a ≥30% PSA decline after 12 weeks from the start of dose escalation therapy.
COMPLETED
PHASE2
41 participants
Up to 12 weeks from start of dose escalation
2020-08-17
Participant Flow
Participants were recruited through the Urologic Oncology Program at University of California, San Francisco
All participants were prescribed the standard dose(STD). Participants who did not exhibit prostate-specific antigen (PSA) decline at 12 weeks were deemed 'primary-resistant' and taken off study. Participants continued STD until progression, at which time, they were assigned to the escalated dose was for a minimum of 12 weeks.
Participant milestones
| Measure |
Standard Dose
Abiraterone 1000 mg once daily Prednisone 5 mg twice daily
|
Escalated Dose
Abiraterone 1000 mg twice daily Prednisone 5 mg twice daily
|
|---|---|---|
|
Standard Dose Regimen
STARTED
|
41
|
0
|
|
Standard Dose Regimen
COMPLETED
|
38
|
0
|
|
Standard Dose Regimen
NOT COMPLETED
|
3
|
0
|
|
Week 12 Evaluation
STARTED
|
38
|
0
|
|
Week 12 Evaluation
COMPLETED
|
32
|
0
|
|
Week 12 Evaluation
NOT COMPLETED
|
6
|
0
|
|
Treatment Regiments Post Week 12
STARTED
|
14
|
18
|
|
Treatment Regiments Post Week 12
COMPLETED
|
5
|
14
|
|
Treatment Regiments Post Week 12
NOT COMPLETED
|
9
|
4
|
Reasons for withdrawal
| Measure |
Standard Dose
Abiraterone 1000 mg once daily Prednisone 5 mg twice daily
|
Escalated Dose
Abiraterone 1000 mg twice daily Prednisone 5 mg twice daily
|
|---|---|---|
|
Standard Dose Regimen
Lack of Efficacy
|
2
|
0
|
|
Standard Dose Regimen
Adverse Event
|
1
|
0
|
|
Week 12 Evaluation
Lack of Efficacy
|
6
|
0
|
|
Treatment Regiments Post Week 12
Not evaluable for response after 12wks
|
0
|
4
|
|
Treatment Regiments Post Week 12
Withdrawal by Subject
|
4
|
0
|
|
Treatment Regiments Post Week 12
Progression after escalation arm closed
|
5
|
0
|
Baseline Characteristics
Measure Description: This measure presents data for the 18 participants that were subsequently randomized to the second treatment arm
Baseline characteristics by cohort
| Measure |
All Patients Who Received Treatment
n=41 Participants
Abiraterone Acetate: Standard dose: 1,000 mg, once daily, oral administration
Increased dose offered after week 12 evaluation to participants who progressed after decline on standard dose: 1,000 mg, twice daily, oral administration
Prednisone: 5 mg, twice daily, oral administration
|
|---|---|
|
Age, Continuous
|
67.4 years
n=18 Participants • Measure Description: This measure presents data for the 18 participants that were subsequently randomized to the second treatment arm
|
|
Sex: Female, Male
Female
|
0 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=18 Participants • This measure presents data for the 18 participants that were subsequently randomized to the second treatment arm
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=18 Participants • This measure presents data for the 18 participants that were subsequently randomized to the second treatment arm
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=18 Participants • This measure presents data for the 18 participants that were subsequently randomized to the second treatment arm
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=18 Participants • This measure presents data for the 18 participants that were subsequently randomized to the second treatment arm
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=18 Participants • This measure presents data for the 18 participants that were subsequently randomized to the second treatment arm
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=18 Participants • This measure presents data for the 18 participants that were subsequently randomized to the second treatment arm
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=18 Participants • This measure presents data for the 18 participants that were subsequently randomized to the second treatment arm
|
|
Race (NIH/OMB)
White
|
16 Participants
n=18 Participants • This measure presents data for the 18 participants that were subsequently randomized to the second treatment arm
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=18 Participants • This measure presents data for the 18 participants that were subsequently randomized to the second treatment arm
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=18 Participants • This measure presents data for the 18 participants that were subsequently randomized to the second treatment arm
|
|
Region of Enrollment
United States
|
41 participants
n=41 Participants
|
|
Prior Therapies
Radical Prostatectomy
|
12 Participants
n=41 Participants
|
|
Prior Therapies
Definitive Radiotherapy
|
15 Participants
n=41 Participants
|
|
Prior Therapies
Metastatic at Diagnosis
|
14 Participants
n=41 Participants
|
|
Prostate Specific Antigen levels
|
23.18 ng/dl
n=41 Participants
|
PRIMARY outcome
Timeframe: Up to 12 weeks from start of dose escalationA PSA response for the dose escalation group is defined as a participant with a documented PSA decline after 12 weeks of therapy with standard-dose, then had disease progression, and then achieved a ≥30% PSA decline after 12 weeks from the start of dose escalation therapy.
Outcome measures
| Measure |
Dose Escalation (CTCAE Grade 3)
Worst grade adverse event with CTCAE Grade 3 for patients taking Abiraterone 1000 mg twice daily, Prednisone 5 mg twice daily
|
Dose Escalation (CTCAE Grade 4)
Worst grade adverse event with CTCAE Grade 4 for patients taking Abiraterone 1000 mg twice daily, Prednisone 5 mg twice daily
|
Dose Escalation
n=14 Participants
Abiraterone 1,000 mg, twice daily, Prednisone 5 mg twice daily
|
Concentration at Time of Disease Progression on Standard Dose
Plasma Abiraterone concentration at time of disease progression on standard dose
|
|---|---|---|---|---|
|
Number of Patients With PSA Response From Dose Escalation
|
—
|
—
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 24 monthsFrequency of any treatment-related toxicity with increased-dose Abiraterone Acetate by maximum observed grade will be tabulated for the study cohort. Toxicities will be graded for management according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 as a measure of patient safety.
Outcome measures
| Measure |
Dose Escalation (CTCAE Grade 3)
n=18 Participants
Worst grade adverse event with CTCAE Grade 3 for patients taking Abiraterone 1000 mg twice daily, Prednisone 5 mg twice daily
|
Dose Escalation (CTCAE Grade 4)
n=18 Participants
Worst grade adverse event with CTCAE Grade 4 for patients taking Abiraterone 1000 mg twice daily, Prednisone 5 mg twice daily
|
Dose Escalation
n=18 Participants
Abiraterone 1,000 mg, twice daily, Prednisone 5 mg twice daily
|
Concentration at Time of Disease Progression on Standard Dose
n=18 Participants
Plasma Abiraterone concentration at time of disease progression on standard dose
|
|---|---|---|---|---|
|
Number of Participants With Worst-grade, Treatment-related Toxicities for Dose Escalation Group
Hypokalemia
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst-grade, Treatment-related Toxicities for Dose Escalation Group
Purpura
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst-grade, Treatment-related Toxicities for Dose Escalation Group
Dry Mouth
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst-grade, Treatment-related Toxicities for Dose Escalation Group
Hypertension
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst-grade, Treatment-related Toxicities for Dose Escalation Group
Alanine aminotransferase increase
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-grade, Treatment-related Toxicities for Dose Escalation Group
Irritability
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst-grade, Treatment-related Toxicities for Dose Escalation Group
Aspartate aminotransferase increased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst-grade, Treatment-related Toxicities for Dose Escalation Group
Fatigue
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: up to 24 monthsTime to PSA progression as defined by RECIST criteria or by the Prostate Cancer Working Group 2 (PCWG) criteria for patients whom were treated with increased dose Abiraterone Acetate.
Outcome measures
| Measure |
Dose Escalation (CTCAE Grade 3)
Worst grade adverse event with CTCAE Grade 3 for patients taking Abiraterone 1000 mg twice daily, Prednisone 5 mg twice daily
|
Dose Escalation (CTCAE Grade 4)
Worst grade adverse event with CTCAE Grade 4 for patients taking Abiraterone 1000 mg twice daily, Prednisone 5 mg twice daily
|
Dose Escalation
n=14 Participants
Abiraterone 1,000 mg, twice daily, Prednisone 5 mg twice daily
|
Concentration at Time of Disease Progression on Standard Dose
Plasma Abiraterone concentration at time of disease progression on standard dose
|
|---|---|---|---|---|
|
Time to PSA Progression for Dose Escalation Cohort
|
—
|
—
|
12 months
Interval 6.0 to 14.5
|
—
|
SECONDARY outcome
Timeframe: up to 24 monthsPopulation: Progression-free survival could not be calculated due to the lack of objective response in the dose escalation group (i.e. no patients were progression-free).
Progression free survival for patients treated with increased dose Abiraterone Acetate
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Only 26 patients on the standard dose had pharmacokinetic samples available for analysis at time of first blood draw. No patients displayed a response to increased-dose therapy therefore data for concentration at time of response to increased dose was not collected.
Pharmacokinetic assessment at the initiation of standard dose therapy, at the time of initial disease progression, at the time of a response to increased dose of abiraterone acetate and at the time of disease progression on increased-dose therapy.
Outcome measures
| Measure |
Dose Escalation (CTCAE Grade 3)
Worst grade adverse event with CTCAE Grade 3 for patients taking Abiraterone 1000 mg twice daily, Prednisone 5 mg twice daily
|
Dose Escalation (CTCAE Grade 4)
n=14 Participants
Worst grade adverse event with CTCAE Grade 4 for patients taking Abiraterone 1000 mg twice daily, Prednisone 5 mg twice daily
|
Dose Escalation
n=26 Participants
Abiraterone 1,000 mg, twice daily, Prednisone 5 mg twice daily
|
Concentration at Time of Disease Progression on Standard Dose
n=26 Participants
Plasma Abiraterone concentration at time of disease progression on standard dose
|
|---|---|---|---|---|
|
Serum Concentration Levels of Abiraterone Acetate Over Time
|
—
|
31.5 nanograms per millilitre (ng/mL)
Interval 5.2 to 148.0
|
5.5 nanograms per millilitre (ng/mL)
Interval 1.26 to 56.2
|
14.2 nanograms per millilitre (ng/mL)
Interval 0.8 to 221.0
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Testosterone levels were maximally suppressed below the laboratory limit of detection (LOD) at week 12 for patients on standard-dose therapy so no correlation could be performed. There were no responders in dose escalation so evaluation of hormonal changes with dose-escalated group was not pursued.
Pearson's correlation coefficients ("r") will be calculated to summarize the relationship between testosterone values at baseline and at 12 weeks. Testosterone labs will be obtained at an earlier time point if the patient comes off study for disease progression before week 12. Coefficients are on a continuous scale ranging from -1 to +1 with a value of -1 indicating a perfect negative linear association of testosterone levels between the 2 time points, a value of 0 indicating no association between testosterone levels between the two time points, and a value of +1 indicating a positive linear association of testosterone levels between the two time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Testosterone levels were maximally suppressed below the laboratory limit of detection (LOD) at week 12 for patients on standard-dose therapy so no correlation could be performed. There were no responders in the dose escalation group so evaluation of hormonal changes with dose-escalated group was not pursued.
The distribution of the baseline testosterone levels and the change in hormone level at 12 weeks will be compared between patients experiencing a PSA decline \>30% (responders) and patients without such a PSA decline (primary-resistant) using a two group t statistic. Measurements will be obtained at an earlier time point if the patient comes off study for disease progression before week 12.
Outcome measures
| Measure |
Dose Escalation (CTCAE Grade 3)
Worst grade adverse event with CTCAE Grade 3 for patients taking Abiraterone 1000 mg twice daily, Prednisone 5 mg twice daily
|
Dose Escalation (CTCAE Grade 4)
Worst grade adverse event with CTCAE Grade 4 for patients taking Abiraterone 1000 mg twice daily, Prednisone 5 mg twice daily
|
Dose Escalation
n=7 Participants
Abiraterone 1,000 mg, twice daily, Prednisone 5 mg twice daily
|
Concentration at Time of Disease Progression on Standard Dose
n=19 Participants
Plasma Abiraterone concentration at time of disease progression on standard dose
|
|---|---|---|---|---|
|
Comparison of Circulating Testosterone Levels Between Primary-Resistant Patients and Responders
|
—
|
—
|
NA Nanograms per decilitre (ng/dL)
Standard Deviation NA
below the level of detection
|
NA Nanograms per decilitre (ng/dL)
Standard Deviation NA
below the level of detection
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: No DHEA values were collected for week 12 in dose escalation group so correlation of for dose escalation could not be performed.
Pearson's correlation coefficients ("r") will be calculated to summarize the relationship between DHEA values at baseline and at 12 weeks. DHEA labs will be obtained at an earlier time point if the patient comes off study for disease progression before week 12. Coefficients are on a continuous scale ranging from -1 to +1 with a value of -1 indicating a perfect negative linear association of DHEA levels between the 2 time points, a value of 0 indicating no association between DHEA levels between the two time points, and a value of +1 indicating a positive linear association of DHEA levels between the two time points.
Outcome measures
| Measure |
Dose Escalation (CTCAE Grade 3)
Worst grade adverse event with CTCAE Grade 3 for patients taking Abiraterone 1000 mg twice daily, Prednisone 5 mg twice daily
|
Dose Escalation (CTCAE Grade 4)
Worst grade adverse event with CTCAE Grade 4 for patients taking Abiraterone 1000 mg twice daily, Prednisone 5 mg twice daily
|
Dose Escalation
n=26 Participants
Abiraterone 1,000 mg, twice daily, Prednisone 5 mg twice daily
|
Concentration at Time of Disease Progression on Standard Dose
Plasma Abiraterone concentration at time of disease progression on standard dose
|
|---|---|---|---|---|
|
Correlation of Circulating Dehydroepiandrosterone (DHEA) Levels From Baseline to Week 12
|
—
|
—
|
0 correlation coefficient (r)
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Twenty-six patients had both baseline and follow-up samples available for analysis. There were no responders in dose escalation group so evaluation of hormonal changes with dose-escalated group was not pursued.
The distribution of the baseline DHEA levels and the change in hormone level at 12 weeks will be compared between patients experiencing a PSA decline \>30% (responders) and patients without such a PSA decline (primary-resistant) using a two group t statistic. Measurements will be obtained at an earlier time point if the patient comes off study for disease progression before week 12.
Outcome measures
| Measure |
Dose Escalation (CTCAE Grade 3)
Worst grade adverse event with CTCAE Grade 3 for patients taking Abiraterone 1000 mg twice daily, Prednisone 5 mg twice daily
|
Dose Escalation (CTCAE Grade 4)
Worst grade adverse event with CTCAE Grade 4 for patients taking Abiraterone 1000 mg twice daily, Prednisone 5 mg twice daily
|
Dose Escalation
n=7 Participants
Abiraterone 1,000 mg, twice daily, Prednisone 5 mg twice daily
|
Concentration at Time of Disease Progression on Standard Dose
n=19 Participants
Plasma Abiraterone concentration at time of disease progression on standard dose
|
|---|---|---|---|---|
|
Comparison of Circulating DHEA Levels Between Primary-Resistant and Responders
Initial draw
|
—
|
—
|
56.2 ng/dL
Interval 11.2 to 223.9
|
79.4 ng/dL
Interval 11.2 to 281.83
|
|
Comparison of Circulating DHEA Levels Between Primary-Resistant and Responders
Progression / Week 12
|
—
|
—
|
28.5 ng/dL
Interval 14.1 to 141.2
|
13.5 ng/dL
Interval 3.1 to 44.7
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: DHEA-S levels were maximally suppressed below the laboratory limit of detection (LOD) at week 12 for patients on standard-dose therapy so no correlation could be performed. There were no responders in dose escalation so evaluation of hormonal changes with dose-escalated group was not pursued.
Pearson's correlation coefficients ("r") will be calculated to summarize the relationship between DHEA-S values at baseline and at 12 weeks. DHEA-S labs will be obtained at an earlier time point if the patient comes off study for disease progression before week 12. Coefficients are on a continuous scale ranging from -1 to +1 with a value of -1 indicating a perfect negative linear association of DHEA-S levels between the 2 time points, a value of 0 indicating no association between DHEA-S levels between the two time points, and a value of +1 indicating a positive linear association of DHEA-S levels between the two time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 12Population: DHEA-S levels were maximally suppressed below the laboratory limit of detection (LOD) at week 12 for patients on standard-dose therapy so no correlation could be performed. There were no responders in dose escalation so evaluation of hormonal changes with dose-escalated group was not pursued.
The distribution of the baseline DHEA-S levels and the change in hormone level at 12 weeks will be compared between patients experiencing a PSA decline \>30% (responders) and patients without such a PSA decline (primary-resistant) using a two group t statistic. Measurements will be obtained at an earlier time point if the patient comes off study for disease progression before week 12.
Outcome measures
| Measure |
Dose Escalation (CTCAE Grade 3)
Worst grade adverse event with CTCAE Grade 3 for patients taking Abiraterone 1000 mg twice daily, Prednisone 5 mg twice daily
|
Dose Escalation (CTCAE Grade 4)
Worst grade adverse event with CTCAE Grade 4 for patients taking Abiraterone 1000 mg twice daily, Prednisone 5 mg twice daily
|
Dose Escalation
n=7 Participants
Abiraterone 1,000 mg, twice daily, Prednisone 5 mg twice daily
|
Concentration at Time of Disease Progression on Standard Dose
n=19 Participants
Plasma Abiraterone concentration at time of disease progression on standard dose
|
|---|---|---|---|---|
|
Comparison of Circulating DHEA-S Levels Between Primary-Resistant Patients and Responders
|
—
|
—
|
NA microgram per deciliter (µg/dL)
Standard Deviation NA
below the level of detection
|
NA microgram per deciliter (µg/dL)
Standard Deviation NA
below the level of detection
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Androstenedione levels were maximally suppressed below the laboratory limit of detection (LOD) at week 12 for patients on standard-dose therapy so no correlation could be performed. There were no responders in dose escalation so evaluation of hormonal changes with dose-escalated group was not pursued.
Pearson's correlation coefficients ("r") will be calculated to summarize the relationship between androstenedione values at baseline and at 12 weeks. Androstenedione labs will be obtained at an earlier time point if the patient comes off study for disease progression before week 12. Coefficients are on a continuous scale ranging from -1 to +1 with a value of -1 indicating a perfect negative linear association of androstenedione levels between the 2 time points, a value of 0 indicating no association between androstenedione levels between the two time points, and a value of +1 indicating a positive linear association of androstenedione levels between the two time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Androstenedione levels were maximally suppressed below the laboratory limit of detection (LOD) at week 12 for patients on standard-dose therapy so no correlation could be performed. There were no responders in dose escalation so evaluation of hormonal changes with dose-escalated group was not pursued.
The distribution of the baseline androstenedione levels and the change in hormone level at 12 weeks will be compared between patients experiencing a PSA decline \>30% (responders) and patients without such a PSA decline (primary-resistant) using a two group t statistic. Measurements will be obtained at an earlier time point if the patient comes off study for disease progression before week 12.
Outcome measures
| Measure |
Dose Escalation (CTCAE Grade 3)
Worst grade adverse event with CTCAE Grade 3 for patients taking Abiraterone 1000 mg twice daily, Prednisone 5 mg twice daily
|
Dose Escalation (CTCAE Grade 4)
Worst grade adverse event with CTCAE Grade 4 for patients taking Abiraterone 1000 mg twice daily, Prednisone 5 mg twice daily
|
Dose Escalation
n=7 Participants
Abiraterone 1,000 mg, twice daily, Prednisone 5 mg twice daily
|
Concentration at Time of Disease Progression on Standard Dose
n=19 Participants
Plasma Abiraterone concentration at time of disease progression on standard dose
|
|---|---|---|---|---|
|
Comparison of Circulating Androstenedione Levels Between Primary-Resistant Patients and Responders
|
—
|
—
|
NA ng/dL
Standard Deviation NA
below the level of detection
|
NA ng/dL
Standard Deviation NA
below the level of detection
|
Adverse Events
Standard Dose Therapy
Dose Escalation
Serious adverse events
| Measure |
Standard Dose Therapy
n=41 participants at risk
Abiraterone 1000 mg daily, Prednisone 5 mg twice daily
|
Dose Escalation
n=18 participants at risk
Dose Escalation (until PSA decrease of at least 30% after 12 weeks):
Abiraterone 1,000 mg, twice daily, Prednisone 5 mg twice daily
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
2.4%
1/41 • Up to 24 months
|
0.00%
0/18 • Up to 24 months
|
|
Gastrointestinal disorders
Constipation
|
2.4%
1/41 • Up to 24 months
|
0.00%
0/18 • Up to 24 months
|
|
Gastrointestinal disorders
Dental caries
|
2.4%
1/41 • Up to 24 months
|
0.00%
0/18 • Up to 24 months
|
|
Gastrointestinal disorders
Nausea
|
2.4%
1/41 • Up to 24 months
|
0.00%
0/18 • Up to 24 months
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
1/41 • Up to 24 months
|
0.00%
0/18 • Up to 24 months
|
|
General disorders
Fatigue
|
0.00%
0/41 • Up to 24 months
|
5.6%
1/18 • Up to 24 months
|
|
Infections and infestations
Lung infection
|
0.00%
0/41 • Up to 24 months
|
5.6%
1/18 • Up to 24 months
|
|
Infections and infestations
Upper respiratory infection
|
2.4%
1/41 • Up to 24 months
|
0.00%
0/18 • Up to 24 months
|
|
Investigations
Alanine aminotransferase increased
|
2.4%
1/41 • Up to 24 months
|
0.00%
0/18 • Up to 24 months
|
|
Investigations
Aspartate aminotransferase increased
|
2.4%
1/41 • Up to 24 months
|
0.00%
0/18 • Up to 24 months
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/41 • Up to 24 months
|
5.6%
1/18 • Up to 24 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/41 • Up to 24 months
|
5.6%
1/18 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/41 • Up to 24 months
|
5.6%
1/18 • Up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
2.4%
1/41 • Up to 24 months
|
5.6%
1/18 • Up to 24 months
|
Other adverse events
| Measure |
Standard Dose Therapy
n=41 participants at risk
Abiraterone 1000 mg daily, Prednisone 5 mg twice daily
|
Dose Escalation
n=18 participants at risk
Dose Escalation (until PSA decrease of at least 30% after 12 weeks):
Abiraterone 1,000 mg, twice daily, Prednisone 5 mg twice daily
|
|---|---|---|
|
Vascular disorders
Hypertension
|
12.2%
5/41 • Up to 24 months
|
11.1%
2/18 • Up to 24 months
|
|
Vascular disorders
Hot flashes
|
12.2%
5/41 • Up to 24 months
|
0.00%
0/18 • Up to 24 months
|
|
Vascular disorders
Vascular disorders - Other, specify
|
0.00%
0/41 • Up to 24 months
|
5.6%
1/18 • Up to 24 months
|
|
Gastrointestinal disorders
Diarrhea
|
9.8%
4/41 • Up to 24 months
|
0.00%
0/18 • Up to 24 months
|
|
Gastrointestinal disorders
Nausea
|
7.3%
3/41 • Up to 24 months
|
5.6%
1/18 • Up to 24 months
|
|
Gastrointestinal disorders
Dyspepsia
|
7.3%
3/41 • Up to 24 months
|
0.00%
0/18 • Up to 24 months
|
|
Gastrointestinal disorders
Vomiting
|
7.3%
3/41 • Up to 24 months
|
0.00%
0/18 • Up to 24 months
|
|
Gastrointestinal disorders
Oral pain
|
2.4%
1/41 • Up to 24 months
|
5.6%
1/18 • Up to 24 months
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/41 • Up to 24 months
|
5.6%
1/18 • Up to 24 months
|
|
General disorders
Fatigue
|
12.2%
5/41 • Up to 24 months
|
11.1%
2/18 • Up to 24 months
|
|
General disorders
Pain
|
9.8%
4/41 • Up to 24 months
|
5.6%
1/18 • Up to 24 months
|
|
General disorders
Edema limbs
|
7.3%
3/41 • Up to 24 months
|
0.00%
0/18 • Up to 24 months
|
|
General disorders
Irritability
|
0.00%
0/41 • Up to 24 months
|
5.6%
1/18 • Up to 24 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
14.6%
6/41 • Up to 24 months
|
11.1%
2/18 • Up to 24 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
9.8%
4/41 • Up to 24 months
|
0.00%
0/18 • Up to 24 months
|
|
Metabolism and nutrition disorders
Anorexia
|
2.4%
1/41 • Up to 24 months
|
5.6%
1/18 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.6%
6/41 • Up to 24 months
|
0.00%
0/18 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.8%
4/41 • Up to 24 months
|
0.00%
0/18 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
2.4%
1/41 • Up to 24 months
|
5.6%
1/18 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/41 • Up to 24 months
|
5.6%
1/18 • Up to 24 months
|
|
Infections and infestations
Upper respiratory infection
|
12.2%
5/41 • Up to 24 months
|
0.00%
0/18 • Up to 24 months
|
|
Infections and infestations
Skin infection
|
2.4%
1/41 • Up to 24 months
|
5.6%
1/18 • Up to 24 months
|
|
Nervous system disorders
Dizziness
|
7.3%
3/41 • Up to 24 months
|
0.00%
0/18 • Up to 24 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.9%
2/41 • Up to 24 months
|
5.6%
1/18 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Bruising
|
9.8%
4/41 • Up to 24 months
|
0.00%
0/18 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Fall
|
9.8%
4/41 • Up to 24 months
|
0.00%
0/18 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Fracture
|
9.8%
4/41 • Up to 24 months
|
0.00%
0/18 • Up to 24 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
9.8%
4/41 • Up to 24 months
|
0.00%
0/18 • Up to 24 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/41 • Up to 24 months
|
5.6%
1/18 • Up to 24 months
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/41 • Up to 24 months
|
5.6%
1/18 • Up to 24 months
|
|
Renal and urinary disorders
Urinary incontinence
|
7.3%
3/41 • Up to 24 months
|
5.6%
1/18 • Up to 24 months
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/41 • Up to 24 months
|
5.6%
1/18 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/41 • Up to 24 months
|
11.1%
2/18 • Up to 24 months
|
|
Eye disorders
Cataract
|
0.00%
0/41 • Up to 24 months
|
5.6%
1/18 • Up to 24 months
|
|
Investigations
Creatinine increased
|
12.2%
5/41 • Up to 24 months
|
5.6%
1/18 • Up to 24 months
|
|
Investigations
Alanine aminotransferase increased
|
7.3%
3/41 • Up to 24 months
|
5.6%
1/18 • Up to 24 months
|
|
Investigations
Aspartate aminotransferase increased
|
7.3%
3/41 • Up to 24 months
|
5.6%
1/18 • Up to 24 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/41 • Up to 24 months
|
5.6%
1/18 • Up to 24 months
|
Additional Information
Dr. Terry Friedlander, MD
University of California, San Francisco
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place