Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Antineoplastic Agents

Anti-Inflammatory Agents

Reproductive Control Agents

Hormones

Abiraterone Acetate

Prednisone

Leuprolide

Goserelin

Prolactin Release-Inhibiting Factors

Glucocorticoids

Hormone Antagonists

Antineoplastic Agents, Hormonal

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

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.

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.

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

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.

LHRHa

Cougar Biotechnology, Inc. Clinical Trial

Christopher Logothetis, MD

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 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.

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

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

The table below shows number of participants in each treatment group with a pathology tumor stage less than or equal to pT2.

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.

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.

Cougar Biotechnology, Inc.

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

AA+LHRHa

Total

Age, Continuous

Sex: Female, Male

Senior Director

Intent-to-treat (ITT) analysis set, which included all participants who were randomized to study.

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)

Number of Participants With a Positive Surgical Margin at Radical Prostatectomy

Intent-to-treat (ITT) analysis set, which included all participants who were randomized to study. Here, "N" (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Neo-adjuvant Abiraterone + Luteinizing Hormone-Releasing Hormone (LHRH) Versus LHRH in Prostate Cancer	NCT01088529	Prostate Cancer	Abiraterone Ace... Prednisone LHRHa	18 Years -	Cougar Biotechnology, Inc.
Neo-adjuvant Abiraterone + Luteinizing Hormone-Releasing Hormone (LHRH) Versus LHRH in Prostate Cancer	NCT01088529	Prostate Cancer	Abiraterone Ace... Prednisone LHRHa	18 Years -	Cougar Biotechnology, Inc.

Spots Global Cancer Trial Database for neoadjuvant prostate cancer