Clinical trial NCT01199146: Abiraterone Post Ketoconazole for Prostate Cancer
Official title: A Phase II Study of Abiraterone Acetate in Patients With Castration Resistant Prostate Cancer (CRPC) and Prior Therapy With Ketoconazole
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Abiraterone acetate
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson
name: Cougar Biotechnology, Inc.
First posted: 2010-09-10
Enrollment: 42
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Preliminary Evidence of Efficacy of Abiraterone Acetate
timeFrame: 12 weeks from beginning of abiraterone treatment
Secondary outcomes:
measure: Time To Progression (TTP)
timeFrame: beginning of treatment until disease progression according to Prostate Cancer Working Group 2 (PCWG2) criteria
measure: Proportion of Patients With PSA Decline of > 50%
timeFrame: 12 weeks from beginning of therapy
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of California, San Francisco
name: Charles J Ryan, MD
role: PRINCIPAL_INVESTIGATOR
References: