Neo-adjuvant Abiraterone + Luteinizing Hormone-Releasing Hormone (LHRH) Versus LHRH in Prostate Cancer

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

The goal of this clinical research study is to find out how treatment with abiraterone acetate in combination with prednisone and a Luteinizing Hormone-Releasing Hormone (LHRH) analogue changes the tumor in comparison to treatment with an LHRH analogue alone. Objectives: Primary Objective: To assess the difference in pathologic stage \< pT2 between Group A and Group B. Secondary Objective: * To assess and compare the changes in levels of androgens (pre, during, and post treatment) in the serum, primary tumor microenvironment and bone marrow between Group A and Group B. * To assess changes in biomarkers related to androgen signaling and other cancer-related pathways between Group A and Group B. * To assess the difference in rate of positive surgical margins between Group A and Group B. * To assess the safety profile of abiraterone acetate and low dose prednisone in a preoperative setting.

Key facts

Study ID

NCT01088529

Run by

Cougar Biotechnology, Inc.

People needed

66

Starts

2009-12-01

Expected to finish

2013-03-01

Last updated by the study team

2014-05-15

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Histological proof of prostatic adenocarcinoma via a minimum of 6 core biopsy samples
• Clinical stage T1c or T2 with high-grade disease (Gleason's 8-10) on initial biopsy, or clinical stage T2b-T2c with Gleason's grade >/= 7 and PSA > 10ng/ml.
• No evidence of metastatic disease as determined by CT scans and bone scans.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of </= 1
• Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (ANC) > 1,500 and platelet count of > 100,000.
• Normal pituitary and adrenal function
• Patients should be deemed to be candidates for radical prostatectomy.

You may not qualify if…

• Histological variants in the primary tumor (histological variants other than adenocarcinoma); neuroendocrine tumor
• Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
• Uncontrolled hypertension
• Abnormal Liver function
• Active or symptomatic viral hepatitis or chronic liver disease
• Clinically significant heart disease
• Other active malignancy
• History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study drug
• Previous treatment with abiraterone acetate
• Patients who are not appropriate surgical candidates for radical prostatectomy
• Prior chemotherapy or radiation therapy for prostate cancer.
• Condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study
• Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

Where it is running

• Study site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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