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

NCT01088529 | Completed Phase 2 Results DMC

• 2 other identifiers: CR016945COU-AA-203
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Neoadjuvant Prostate Cancer; Abiraterone Acetate; LHRHa; high risk prostate cancer; Radical prostatectomy; Prednisone; Luteinizing Hormone-Releasing Hormone; LHRH analogue

Outcome Measures

Primary Outcomes (1)

• 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)

  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 Outcomes (2)

• Number of Participants With a Positive Surgical Margin at Radical Prostatectomy

  At the end of Cycle 3 (at radical prostatectomy)

• Number of Participants With Prostate-Specific Antigen Response

  Cycle 3 Day 1

Study Arms (2)

AA+LHRHa

EXPERIMENTAL

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; Drug: Prednisone; Drug: LHRHa

LHRHa

EXPERIMENTAL

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

Interventions

Abiraterone Acetate DRUG

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

Also known as: CB7630

AA+LHRHa

Prednisone DRUG

5 mg orally daily.

AA+LHRHa

LHRHa 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.

Also known as: Lupron®, leuprolide, Zoladex®, goserelin

AA+LHRHa; LHRHa

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Cougar Biotechnology, Inc.: lead

Study Sites (1)

Unknown Facility

Houston, Texas, United States

Location

Related Links

• NATIONAL CANCER INSTITUTE
• NATIONAL INSTITUTE OF HEALTH

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Abiraterone Acetate; Prednisone; Leuprolide; Goserelin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Senior Director
• Organization: Janssen R&D US

ClinicalTrialDisclosure@its.jnj.com

Study Officials

• Cougar Biotechnology, Inc. Clinical Trial

  Cougar Biotechnology, Inc.

  STUDY DIRECTOR

• Christopher Logothetis, MD

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2010
• First Posted: March 17, 2010
• Study Start: December 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: May 15, 2014
• Results First Posted: April 9, 2014

Record last verified: 2014-05

Locations

US (1)