Abiraterone Post Ketoconazole for Prostate Cancer

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

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

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Abiraterone acetate

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94115
      • University of California, San Francisco
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Abiraterone acetate	Drug: Abiraterone acetate; Abiraterone acetate 1000 mg by mouth per day; Other Names: CB7630

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preliminary Evidence of Efficacy of Abiraterone Acetate	number of patients with ≥ 30% PSA decline after 12 weeks of abiraterone treatment	12 weeks from beginning of abiraterone treatment

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Johnson & Johnson; Cougar Biotechnology, Inc.
• Investigators: Principal Investigator: Charles J Ryan, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2010
• Primary Completion (Actual): January 4, 2013
• Study Completion (Actual): March 14, 2016

Study Registration Dates

• First Submitted: September 9, 2010
• First Submitted That Met QC Criteria: September 9, 2010
• First Posted (Estimate): September 10, 2010

Study Record Updates

• Last Update Posted (Actual): January 8, 2018
• Last Update Submitted That Met QC Criteria: December 6, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Abiraterone acetate
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Steroid Synthesis Inhibitors; Abiraterone Acetate
• Other Study ID Numbers: CC# 085514