Neo-adjuvant Abiraterone + Luteinizing Hormone-Releasing Hormone (LHRH) Versus LHRH in Prostate Cancer
This study is currently recruiting participants.
Verified March 2013 by Cougar Biotechnology, Inc.
Sponsor:
Cougar Biotechnology, Inc.
Information provided by (Responsible Party):
Cougar Biotechnology, Inc.
ClinicalTrials.gov Identifier:
NCT01088529
First received: March 15, 2010
Last updated: March 7, 2013
Last verified: March 2013
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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:
Drug Information available for:
Prednisone
Luteinizing Hormone
Gonadorelin
Gonadorelin hydrochloride
Goserelin
Leuprolide acetate
Goserelin acetate
Abiraterone acetate
U.S. FDA Resources
Further study details as provided by Cougar Biotechnology, Inc.:
Primary Outcome Measures:
- Proportion of Patients with Pathologic Stage ≤ pT2 [ Time Frame: Every 2-4 weeks prior to prostatectomy, 1 and 3 months after and every 6 months thereafter for 8 years. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 66 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group A
Abiraterone acetate, a LHRHa (LHRH analogue), and prednisone
|
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:
|
|
Experimental: Group B
LHRHa alone
|
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:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01088529
Contacts
| Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: | JNJ.CT@sylogent.com |
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Christopher Logothetis, MD 713-792-2830 | |
| Active, not recruiting | |
| 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 |
| Last Updated: | March 7, 2013 |
| 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 Leuprolide Goserelin |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Glucocorticoids Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Anti-Inflammatory Agents Fertility Agents, Female Fertility Agents Reproductive Control Agents |
ClinicalTrials.gov processed this record on June 17, 2013