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

NCT ID: NCT01088529

Last Updated: 2014-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2013-03-31

Brief Summary

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.

Detailed Description

Study Groups:

Participants who are eligible to take part in this study will be randomly assigned (as in the flip of a coin) to 1 of 2 groups:

• Those who are in Group A will take abiraterone acetate, a LHRH analogue, and prednisone.
• Those who are in Group B will receive a LHRH analogue alone. Participants will have 2 out of 3 chances of being placed in Group A or 1 out of 3 chances of being placed in Group B.

Participants in both groups will receive the study drug(s) for about 3 months followed by a prostatectomy (prostate surgery) between 2 and 4 weeks after they stop taking the study drug(s).

Length of Study:

Participants will receive study drugs on this study for about 3 months before having surgery to remove their prostate about 2-4 weeks later. Participants will be removed from this study if the disease gets worse, if they experience intolerable side effects, or their study doctors feel that it is in their best interest to stop the study.

Long-Term Follow-Up:

Participants will return to the clinic 1 month, 3 months, 6 months, and then every 6 months (for up to 8 years) after your surgery for follow-up visits. Up to 66 patients will be take part in this study. All will be enrolled at M. D. Anderson after their surgery.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AA+LHRHa

Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) and 1,000 mg abiraterone acetate (AA) plus 5 mg of prednisone daily for 3 months prior to radical prostatectomy.

Group Type: EXPERIMENTAL

Abiraterone Acetate

Intervention Type: DRUG

1000 mg oral daily for 3 months followed by a prostatectomy.

Prednisone

Intervention Type: DRUG

5 mg orally daily.

LHRHa

Intervention Type: DRUG

LHRH analogue (either leuprolide or goserelin): Leuprolide is an intramuscular injection, and goserelin subcutaneous (under skin) of abdomen, given either 1 injection every 3 months or 1 injection each month for 3 months.

LHRHa

Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) prior to radical prostatectomy.

Group Type: EXPERIMENTAL

LHRHa

Intervention Type: DRUG

LHRH analogue (either leuprolide or goserelin): Leuprolide is an intramuscular injection, and goserelin subcutaneous (under skin) of abdomen, given either 1 injection every 3 months or 1 injection each month for 3 months.

Interventions

Abiraterone Acetate

1000 mg oral daily for 3 months followed by a prostatectomy.

Intervention Type: DRUG

Prednisone

5 mg orally daily.

Intervention Type: DRUG

LHRHa

LHRH analogue (either leuprolide or goserelin): Leuprolide is an intramuscular injection, and goserelin subcutaneous (under skin) of abdomen, given either 1 injection every 3 months or 1 injection each month for 3 months.

Intervention Type: DRUG

Other Intervention Names

CB7630; Lupron®; leuprolide; Zoladex®; goserelin

Eligibility Criteria

Inclusion Criteria

1. Histological proof of prostatic adenocarcinoma via a minimum of 6 core biopsy samples

2. 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.

3. No evidence of metastatic disease as determined by CT scans and bone scans.

4. Eastern Cooperative Oncology Group (ECOG) Performance Status of </= 1

5. Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (ANC) > 1,500 and platelet count of > 100,000.

6. Normal pituitary and adrenal function

7. Patients should be deemed to be candidates for radical prostatectomy.

Exclusion Criteria

1. Histological variants in the primary tumor (histological variants other than adenocarcinoma); neuroendocrine tumor

2. Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection

3. Uncontrolled hypertension

4. Abnormal Liver function

5. Active or symptomatic viral hepatitis or chronic liver disease

6. Clinically significant heart disease

7. Other active malignancy

8. History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study drug

9. Previous treatment with abiraterone acetate

10. Patients who are not appropriate surgical candidates for radical prostatectomy

11. Prior chemotherapy or radiation therapy for prostate cancer.

12. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Cougar Biotechnology, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cougar Biotechnology, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Cougar Biotechnology, Inc.

Christopher Logothetis, MD

Role: PRINCIPAL_INVESTIGATOR

UT MD Anderson Cancer Center

Locations

Houston, Texas, United States

Countries

United States

Related Links

http://www.cancer.gov

NATIONAL CANCER INSTITUTE

http://www.nlm.nih.gov/medlineplus/prostatecancer.html

NATIONAL INSTITUTE OF HEALTH

Other Identifiers

COU-AA-203

Identifier Type: OTHER

Identifier Source: secondary_id

CR016945

Identifier Type: -

Identifier Source: org_study_id