Phase 2
N=66
Neo-adjuvant Abiraterone + Luteinizing Hormone-Releasing Hormone (LHRH) Versus LHRH in Prostate Cancer
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01088529 ↗Enrolled (actual)
66
Serious AEs
6.2%
Results posted
Apr 2014
Primary outcome: 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) — 24; 8 participants — p=0.2148
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Abiraterone Acetate (Drug); Prednisone (Drug); LHRHa (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Cougar Biotechnology, Inc.
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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) |
24; 8 | 0.2148 |
| SECONDARY Number of Participants With a Positive Surgical Margin at Radical Prostatectomy |
6; 6 | 0.1796 |
| SECONDARY Number of Participants With Prostate-Specific Antigen Response |
32; 0 | <0.0001 sig |
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.
Eligibility 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 1,500 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.
Data sourced from ClinicalTrials.gov (NCT01088529). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.