Hormone refractory prostate cancer MedDRA version: 8.0 Classification code 10062904
Conditions
Sponsors
Cougar Biotechnology, Inc
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Age >18 years and able to comply with protocol requirements. 2) Signed informed consent. 3) Histologically documented adenocarcinoma of the prostate, clinically refractory or resistant to hormone therapy, as documented by progression following at least one hormonal therapy, which must include orchiectomy or ongoing treatment with gonadotropin releasing hormone (GnRH) agonists. 4) PSA evidence for progressive prostate cancer consists of a PSA level of at least 5 ng/ml which has risen on at least 2 successive occasions, at least 2 weeks apart. If the confirmatory PSA value is less than the screening PSA value, then an additional test for rising PSA will be required to document progression. 5) Patients who were withdrawn from anti-androgen therapy less than 6 months prior to inclusion in the study require one PSA higher than the last pre-withdrawal PSA or 2 increases in PSA documented after the post-withdrawal nadir = 4 weeks from treatment withdrawal if treated with flutamide and =6 weeks if treated with bicalutamide or nilutamide. Patients with progression of measurable disease (RECIST) or progression of bone disease must also fit the criterion for PSA progression. 6) ECOG performance status: 0-1. 7) Creatinine =1.5 x upper limit of normal (ULN) or a calculated creatinine clearance > 50 mL/min. 8) Potassium = 3.5mmol/l. 9) Systolic blood pressure =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Prior cytotoxic chemotherapy for prostate cancer (including estramustine, docetaxel and mitoxantrone). All other systemic chemotherapy must have been completed at least 2 years prior to enrolment. 2) Prior therapeutic radionucleotide therapy for prostate cancer. 3) External beam radiotherapy, brachytherapy or cryotherapy to the prostate bed within 4 weeks of start of study. 4) Prior ketoconazole, aminoglutethimide or treatment with any investigational anticancer agent, including systemic corticosteroids for the treatment of prostate cancer, within 4 weeks of start of study. 5) Patients receiving any other hormonal therapy, including any dose of megestrol acetate (Megace), Proscar (finasteride), any herbal product known to decrease PSA levels (e.g., Saw Palmetto and PC-SPES), or any systemic corticosteroid must discontinue the agent for at least 4 weeks prior to enrolment. Progressive disease (as defined above) must be documented after discontinuation of the hormonal therapy. 6) Treatment with any investigational anticancer agent within 4 weeks of start of study. 7) Patients on stable doses of bisphosphonates that show subsequent tumour progression may continue on this medication; however, patients are not allowed to initiate bisphosphonate therapy within two weeks prior to starting therapy or throughout the study. 8) No supplements or complementary medicines/botanicals are permitted while on protocol therapy, except for any combination of the following: • conventional multivitamin supplements • selenium • soy supplements 9) Haemoglobin = 9.0 g/dL, ANC = 1.5 x 10 to the power of 9 /L, platelets =100 x 10 to the power of 9/L. 10) Bilirubin > 1.5 x ULN, AST >2.5 x ULN, ALT > 2.5 x ULN. 11) Patients with serious or uncontrolled co-existent non-malignant diseases. Active or uncontrolled infection. 12) Patients with CNS disease and/or brain metastases. 13) No “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. 14) Clinical and/or biochemical evidence of hyperaldosteronism. 15) Patients with well controlled hypertension with medication will be allowed after the dose escalation study is completed. 16) NYHA Class III or IV Congestive Heart Failure. 17) Myocardial infarction within the 6 months prior to start of study. 18) No active or uncontrolled autoimmune disease that may require corticosteroid therapy during protocol treatment. 19)Major surgery or significant traumatic injury within 4 weeks of start of study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety, tolerability and recommended dose of abiraterone acetate administered orally, by continuous once-daily administration in patients with HRPC. To determine the effect of abiraterone acetate on the pituitary-adrenal-gonad endocrine axis and on adrenal hormones by evaluating serum levels of testosterone and its precursors. To evaluate the efficacy of abiraterone acetate in HRPC at recommended dose. ; Secondary Objective: To evaluate the pharmacokinetic profile of abiraterone acetate. To estimate duration of PSA/objective tumour response. ;Primary end point(s): Confirmed, objective PSA response (according to PSAWG criteria) resulting from abiraterone acetate therapy. All patients achieving a fall in PSA of >50% from baseline, which has been confirmed by a second measurement at least 4 weeks after initial documentation, will fulfill criteria for PSA response. Baseline measurements should be within three days of starting study therapy. Patients achieving a fall of their PSA to less than 0.2ng/ml will be reported as a subset of PSA responders. | — |
Countries
United Kingdom
Outcome results
None listed