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

May 1, 2014 updated by: Cougar Biotechnology, Inc.

A Randomized, Open-Label, Neoadjuvant Prostate Cancer Trial of Abiraterone Acetate Plus LHRHa Versus LHRHa Alone

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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:
  • goserelin
  • Zoladex®
  • Lupron®
  • leuprolide
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:
  • goserelin
  • Zoladex®
  • Lupron®
  • leuprolide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
The table below shows number of participants in each treatment group with a pathology tumor stage less than or equal to pT2.
At the end of Cycle 3 (at radical prostatectomy)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With a Positive Surgical Margin at Radical Prostatectomy
Time Frame: At the end of Cycle 3 (at radical prostatectomy)
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.
At the end of Cycle 3 (at radical prostatectomy)
Number of Participants With Prostate-Specific Antigen Response
Time Frame: Cycle 3 Day 1
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.
Cycle 3 Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cougar Biotechnology, Inc.

Investigators

  • Principal Investigator: Christopher Logothetis, MD, UT MD Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (ACTUAL)

March 1, 2013

Study Completion (ACTUAL)

March 1, 2013

Study Registration Dates

First Submitted

March 15, 2010

First Submitted That Met QC Criteria

March 16, 2010

First Posted (ESTIMATE)

March 17, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

May 15, 2014

Last Update Submitted That Met QC Criteria

May 1, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR016945
  • COU-AA-203 (OTHER: Cougar Biotechnology, Inc.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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