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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cougar Biotechnology, Inc.
ClinicalTrials.gov Identifier:
NCT01088529
First received: March 15, 2010
Last updated: May 1, 2014
Last verified: May 2014
  Purpose

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.

Condition Intervention Phase
Prostate Cancer
Drug: Abiraterone Acetate
Drug: Prednisone
Drug: LHRHa
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Neoadjuvant Prostate Cancer Trial of Abiraterone Acetate Plus LHRHa Versus LHRHa Alone

Resource links provided by NLM:


Further study details as provided by Cougar Biotechnology, Inc.:

Primary Outcome Measures:
  • Number of Participants With a Pathology Tumor Stage of Less Than or Equal to Prostate Cancer Stage at Which the Tumor is Confined to the Prostate (pT2) [ Time Frame: At the end of Cycle 3 (at radical prostatectomy) ] [ Designated as safety issue: No ]
    The table below shows number of participants in each treatment group with a pathology tumor stage less than or equal to pT2.


Secondary Outcome Measures:
  • Number of Participants With a Positive Surgical Margin at Radical Prostatectomy [ Time Frame: At the end of Cycle 3 (at radical prostatectomy) ] [ Designated as safety issue: No ]
    The table below shows number of participants in each treatment group who had positive surgical margins. A positive surgical margin is defined as tumor extending to the inked-surface or margin of the prostate.

  • Number of Participants With Prostate-Specific Antigen Response [ Time Frame: Cycle 3 Day 1 ] [ Designated as safety issue: No ]
    The table below shows number of participants in each treatment group who achieved a prostate-specific antigen (PSA) response defined as a drop in PSA value to less than or equal to 0.2 ng/mL.


Enrollment: 66
Study Start Date: December 2009
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Abiraterone Acetate
1000 mg oral daily for 3 months followed by a prostatectomy.
Other Name: CB7630
Drug: Prednisone
5 mg orally daily.
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.
Other Names:
  • Lupron®
  • leuprolide
  • Zoladex®
  • goserelin
Experimental: 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.
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.
Other Names:
  • Lupron®
  • leuprolide
  • Zoladex®
  • goserelin

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01088529

Locations
United States, Texas
Houston, Texas, United States
Sponsors and Collaborators
Cougar Biotechnology, Inc.
Investigators
Study Director: Cougar Biotechnology, Inc. Clinical Trial Cougar Biotechnology, Inc.
Principal Investigator: Christopher Logothetis, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Cougar Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT01088529     History of Changes
Other Study ID Numbers: CR016945, COU-AA-203
Study First Received: March 15, 2010
Results First Received: March 4, 2014
Last Updated: May 1, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Cougar Biotechnology, Inc.:
Neoadjuvant Prostate Cancer
Abiraterone Acetate
LHRHa
high risk prostate cancer
Radical prostatectomy
Prednisone
Luteinizing Hormone-Releasing Hormone
LHRH analogue

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Prednisone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Glucocorticoids
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on October 19, 2014