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A Phase II Study of Increased-Dose Abiraterone Acetate in Patients With Castration Resistant Prostate Cancer
Phase 2 trial testing Abiraterone Acetate in Castration Resistant Prostate Cancer in 41 participants. Completed in 27 February 2017.
| Lead sponsor | Terence Friedlander, MD |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 41 |
| Start date | 13 March 2013 |
| Primary completion | 27 February 2017 |
| Estimated completion | 27 February 2017 |
| Sites | 2 locations across United States |
Terence Friedlander, MD
18 and older, male only, with Castration Resistant Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Dose Escalation | 0 |
Frequency 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.
| Group | Value | 95% CI |
|---|---|---|
| Dose Escalation (CTCAE Grade 1) | 1 | |
| Dose Escalation (CTCAE Grade 2) | 0 | |
| Dose Escalation (CTCAE Grade 3) | 0 | |
| Dose Escalation (CTCAE Grade 4) | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Dose Escalation (CTCAE Grade 1) | 0 | |
| Dose Escalation (CTCAE Grade 2) | 1 | |
| Dose Escalation (CTCAE Grade 3) | 0 | |
| Dose Escalation (CTCAE Grade 4) | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Dose Escalation (CTCAE Grade 1) | 0 | |
| Dose Escalation (CTCAE Grade 2) | 0 | |
| Dose Escalation (CTCAE Grade 3) | 1 | |
| Dose Escalation (CTCAE Grade 4) | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Dose Escalation (CTCAE Grade 1) | 0 | |
| Dose Escalation (CTCAE Grade 2) | 1 | |
| Dose Escalation (CTCAE Grade 3) | 0 | |
| Dose Escalation (CTCAE Grade 4) | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Dose Escalation (CTCAE Grade 1) | 0 | |
| Dose Escalation (CTCAE Grade 2) | 1 | |
| Dose Escalation (CTCAE Grade 3) | 0 | |
| Dose Escalation (CTCAE Grade 4) | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Dose Escalation (CTCAE Grade 1) | 0 | |
| Dose Escalation (CTCAE Grade 2) | 1 | |
| Dose Escalation (CTCAE Grade 3) | 0 | |
| Dose Escalation (CTCAE Grade 4) | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Dose Escalation (CTCAE Grade 1) | 1 | |
| Dose Escalation (CTCAE Grade 2) | 0 | |
| Dose Escalation (CTCAE Grade 3) | 0 | |
| Dose Escalation (CTCAE Grade 4) | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Dose Escalation (CTCAE Grade 1) | 0 | |
| Dose Escalation (CTCAE Grade 2) | 1 | |
| Dose Escalation (CTCAE Grade 3) | 0 | |
| Dose Escalation (CTCAE Grade 4) | 0 |
Time 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.
| Group | Value | 95% CI |
|---|---|---|
| Dose Escalation | 12 | 6 – 14.5 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Concentration at First Draw on Standard Dose Therapy (4 Weeks) | 5.5 | 1.26 – 56.2 |
| Concentration at Time of Disease Progression on Standard Dose | 14.2 | 0.8 – 221 |
| Concentration at Time of Disease Progression on Increased Dose | 31.5 | 5.2 – 148 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Testosterone in Primary Resistant (STD) | NA | ± NA |
| Testosterone in Responders (STD) | NA | ± NA |
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 betwe
| Group | Value | 95% CI |
|---|---|---|
| Standard Dose | 0 |
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.
| Group | Value | 95% CI |
|---|---|---|
| DHEA in Primary Resistant (STD) | 56.2 | 11.2 – 223.9 |
| DHEA in Responders (STD) | 79.4 | 11.2 – 281.83 |
| Group | Value | 95% CI |
|---|---|---|
| DHEA in Primary Resistant (STD) | 28.5 | 14.1 – 141.2 |
| DHEA in Responders (STD) | 13.5 | 3.1 – 44.7 |
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.
| Group | Value | 95% CI |
|---|---|---|
| DHEA-S in Primary Resistant (STD) | NA | ± NA |
| DHEA-S in Responders (STD) | NA | ± NA |
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.
| Group | Value | 95% CI |
|---|---|---|
| Androstenedione in Primary Resistant (STD) | NA | ± NA |
| Androstenedione in Responders (STD) | NA | ± NA |
Time frame: Up to 24 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Standard Dose Therapy | Dose Escalation |
|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Dental caries | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Fatigue | General disorders | — | — |
| Lung infection | Infections and infestations | — | — |
| Upper respiratory infection | Infections and infestations | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — |
| Hypokalemia | Metabolism and nutrition disorders | — | — |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | — | — |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Reaction | System | Standard Dose Therapy | Dose Escalation |
|---|---|---|---|
| Hypokalemia | Metabolism and nutrition disorders | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — |
| Hypertension | Vascular disorders | — | — |
| Hot flashes | Vascular disorders | — | — |
| Fatigue | General disorders | — | — |
| Upper respiratory infection | Infections and infestations | — | — |
| Creatinine increased | Investigations | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Pain | General disorders | — | — |
| Hypomagnesemia | Metabolism and nutrition disorders | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — |
| Bruising | Injury, poisoning and procedural complications | — | — |
| Fall | Injury, poisoning and procedural complications | — | — |
| Fracture | Injury, poisoning and procedural complications | — | — |
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Edema limbs | General disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Urinary incontinence | Renal and urinary disorders | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Peripheral sensory neuropathy | Nervous system disorders | — | — |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | — | — |
| Vascular disorders - Other, specify | Vascular disorders | — | — |
| Oral pain | Gastrointestinal disorders | — | — |
| Dry mouth | Gastrointestinal disorders | — | — |
| Irritability | General disorders | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — |
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | — | — |
| Flank pain | Musculoskeletal and connective tissue disorders | — | — |
| Skin infection | Infections and infestations | — | — |
| Dry skin | Skin and subcutaneous tissue disorders | — | — |
| Purpura | Skin and subcutaneous tissue disorders | — | — |
| Cystitis noninfective | Renal and urinary disorders | — | — |
| Cataract | Eye disorders | — | — |
| Anxiety | Psychiatric disorders | — | — |
Most-reported serious reactions: Atrial fibrillation, Constipation, Dental caries, Nausea, Vomiting, Fatigue, Lung infection, Upper respiratory infection.
Data from ClinicalTrials.gov NCT01637402 adverse events section.
The purpose of this study is to find out what effects, good and/or bad,an increased dose of Abiraterone Acetate in combination with prednisone has on patients and their prostate cancer. This study will investigate whether an increased-dose (2,000mg daily) is safe and potentially effective when given to patients whose cancer has grown while taking the standard dose.
6 peer-reviewed publications reference this trial (live from Europe PMC):
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