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A Phase II Study of Abiraterone Acetate in Patients With Castration Resistant Prostate Cancer (CRPC) and Prior Therapy With Ketoconazole

Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

A Phase II Study of Abiraterone Acetate in Patients With Castration Resistant Prostate Cancer (CRPC) and Prior Therapy With Ketoconazole

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess preliminary evidence of efficacy of abiraterone acetate in patients who demonstrate evidence of disease progression on ketoconazole

Outcome Time Frame:

12 weeks

Safety Issue:


Principal Investigator

Charles J Ryan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco


United States: Food and Drug Administration

Study ID:

CC# 085514



Start Date:

September 2010

Completion Date:

December 2015

Related Keywords:

  • Prostate Cancer
  • Abiraterone acetate
  • Prostatic Neoplasms



University of California, San FranciscoSan Francisco, California  94143
University of ChicagoChicago, Illinois  60637