Prostate Cancer
Conditions
Keywords
Abiraterone acetate
Brief summary
This is a phase II, open label, single center study to evaluate the efficacy of abiraterone acetate (CB7630) administered to patients with castrate resistant prostate cancer who have experienced disease progression on ketoconazole. It is hypothesized that abiraterone will be active in patients who have experienced disease progression on ketoconazole
Interventions
DRUGAbiraterone acetate
Abiraterone acetate 1000 mg by mouth per day
Sponsors
Johnson & Johnson
Cougar Biotechnology, Inc.
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed adenocarcinoma of the prostate * Prior therapy with ketoconazole for castration resistant prostate cancer. Patients should demonstrate evidence of progression (see below definitions) on ketoconazole or evidence of grades 3/4 toxicities on ketoconazole. 1. Ketoconazole must have been administered for \>28 days 2. At least 27 days must elapse since last ketoconazole dose and first dose of abiraterone acetate * No prior therapy with chemotherapy for metastatic prostate cancer * Metastatic disease based on a positive bone scan or objective imaging on CT scan * Ongoing gonadal androgen deprivation therapy with LHRH analogues or orchiectomy. Patients, who have not had an orchiectomy, must be maintained on effective LHRH analogue therapy for the duration of the trial * Testosterone \< 50 ng/dL * Progressive disease after androgen deprivation: PSA evidence for progressive prostate cancer consists of a PSA level of at least 2 ng/ml which has risen on at least 2 successive occasions, at least 2 weeks apart * Patients who are receiving an antiandrogen as part of primary androgen ablation must demonstrate disease progression following discontinuation of antiandrogen * ECOG Performance Status 0-1 * Age \>18 years and able to comply with protocol requirements * Serum Creatinine ≤1.5 x ULN * Serum potassium \>3.5mmol/L * Bilirubin ≤1.5x ULN * AST and ALT ≤2.5 x ULN * Life expectancy of \>12 weeks
Exclusion criteria
* Therapy with other hormonal therapy, including any dose of megestrol acetate (Megace), finasteride (Proscar), dutasteride (Avodart) any herbal product known to decrease PSA levels (e.g., Saw Palmetto and PC-SPES), or any systemic corticosteroid within 4 weeks prior to first dose of study drug * Therapy with supplements or complementary medicines/botanicals within 4 weeks of first dose of study drug, except for any combination of the following; conventional multivitamin supplements, Selenium, Lycopene and Soy supplements * Prior radiation therapy completed \< 4 weeks prior to enrollment * Prior chemotherapy for castration resistant prostate cancer. Patients who have received chemotherapy for early stage prostate cancer (e.g. as part of a neoadjuvant or adjuvant trial) or for other malignancies are eligible provided that \>1 year has passed since the administration of the last chemotherapy dose. * Hemoglobin ≤9.0 g/dL * Any currently active second malignancy, other than non-melanoma skin cancer Patients are not considered to have a currently active malignancy, if they have completed therapy and are considered by their physician to be at least less than 30% risk of relapse over next 3 months * Blood pressure that is not controlled despite \>2 oral agents (SBP \>160 and DBP \>90 on three or more readings within the screening period) * Serum K+ \<3.5 mmoL/L on more than one reading within the screening period * NYHA Class II, NYHA Class III or IV Congestive Heart Failure * Myocardial infarction within the 6 months prior to the first dose of study drug * Serious intercurrent infections or nonmalignant medical illnesses that are uncontrolled * Concurrent therapy with drugs that are metabolized as substrates of CYP1A2, CYP2D6, or CYP2C19 and are considered by the investigators to pose a risk for drug to drug interactions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preliminary Evidence of Efficacy of Abiraterone Acetate | 12 weeks from beginning of abiraterone treatment | number of patients with ≥ 30% PSA decline after 12 weeks of abiraterone treatment |
Secondary
| Measure | Time frame |
|---|---|
| Time To Progression (TTP) | beginning of treatment until disease progression according to Prostate Cancer Working Group 2 (PCWG2) criteria |
| Proportion of Patients With PSA Decline of > 50% | 12 weeks from beginning of therapy |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Abiraterone Acetate Abiraterone acetate 1000 mg by mouth per day | 39 |
| Total | 39 |
Baseline characteristics
| Characteristic | Abiraterone Acetate |
|---|---|
| Age, Continuous | 71 years |
| Region of Enrollment United States | 39 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 42 |
| other Total, other adverse events | 40 / 42 |
| serious Total, serious adverse events | 5 / 42 |
Outcome results
Primary
Preliminary Evidence of Efficacy of Abiraterone Acetate
number of patients with ≥ 30% PSA decline after 12 weeks of abiraterone treatment
Time frame: 12 weeks from beginning of abiraterone treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Abiraterone Acetate | Preliminary Evidence of Efficacy of Abiraterone Acetate | 20 Participants |
Secondary
Proportion of Patients With PSA Decline of > 50%
Time frame: 12 weeks from beginning of therapy
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Abiraterone Acetate | Proportion of Patients With PSA Decline of > 50% | 19 Participants |
Secondary
Time To Progression (TTP)
Time frame: beginning of treatment until disease progression according to Prostate Cancer Working Group 2 (PCWG2) criteria
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Abiraterone Acetate | Time To Progression (TTP) | 16 weeks |