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

Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

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

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

- 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

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.

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
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.

Type of Study:


Study Design:

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

Outcome Measure:

Proportion of Patients with Pathologic Stage ≤ pT2

Outcome Time Frame:

Every 2-4 weeks prior to prostatectomy, 1 and 3 months after and every 6 months thereafter for 8 years.

Safety Issue:


Principal Investigator

Cougar Biotechnology, Inc. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Cougar Biotechnology, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

December 2009

Completion Date:

March 2013

Related Keywords:

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



Austin, Texas  78705
UT MD Anderson Cancer CenterHouston, Texas  77030