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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01088529
• Other study ID #: CR016945
• Secondary ID: COU-AA-203
• Status: Completed
• Phase: Phase 2
• First received: March 15, 2010
• Last updated: May 1, 2014
• Start date: December 2009
• Est. completion date: March 2013

Study information

• Verified date: May 2014
• Source: Cougar Biotechnology, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Abiraterone Acetate
1000 mg oral daily for 3 months followed by a prostatectomy.
• Prednisone
5 mg orally daily.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cougar Biotechnology, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Number of Participants With a Positive Surgical Margin 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)	No
Secondary	Number of Participants With Prostate-Specific Antigen Response	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	No

External Links

•   AMERICAN SOCIETY OF CLINICAL ONCOLOGY
•   NATIONAL CANCER INSTITUTE
•   NATIONAL INSTITUTE OF HEALTH