Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT01088529Other idCR016945Other idCOU-AA-203

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 66 participants (actual)
Sponsor: Cougar Biotechnology, Inc. · Industry
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: Dec 2009
Primary completion: Mar 2013
Completion: Mar 2013
First posted: 17 Mar 2010 (estimated)
Last update posted: 15 May 2014 (estimated)
Conditions: Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

200920102011201220132014

Ph 2
Neo-adjuvant Abiraterone + Luteinizing Hormone-Releasing Hormone (LHRH) Versus LHRH in Prostate Cancer
NCT01088529
Dec 2009 to Mar 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Abiraterone AcetateDrug
PrednisoneDrug
LHRHaDrug

Arms2

Experimental
AA+LHRHa
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.
Experimental
LHRHa
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.

Primary outcomes1

Outcomes the sponsor listed as 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)
Time frame · At the end of Cycle 3 (at radical prostatectomy)
Registry description
The table below shows number of participants in each treatment group with a pathology tumor stage less than or equal to pT2.

Secondary outcomes(2)

Number of Participants With a Positive Surgical Margin at Radical Prostatectomy
Time frame · At the end of Cycle 3 (at radical prostatectomy)
Registry description
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.
Number of Participants With Prostate-Specific Antigen Response
Time frame · Cycle 3 Day 1
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· At the end of Cycle 3 (at radical prostatectomy)

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)

Group	Value (participants)
AA+LHRHa	24
LHRHa	8

Secondary and other outcome results(2)

Secondary outcomeNumber· At the end of Cycle 3 (at radical prostatectomy)

Number of Participants With a Positive Surgical Margin at Radical Prostatectomy

Group	Value (participants)
AA+LHRHa	6
LHRHa	6

Secondary outcomeNumber· Cycle 3 Day 1

Number of Participants With Prostate-Specific Antigen Response

Group	Value (participants)
AA+LHRHa	32
LHRHa	0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
AA+LHRHaParticipants 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	–	2 / 44	43 / 44
LHRHaParticipants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) prior to radical prostatectomy.	–	2 / 21	21 / 21

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Male
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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