Prostate CancerPhase 2NCT01088529
Neo-adjuvant Abiraterone + Luteinizing Hormone-Releasing Hormone (LHRH) Versus LHRH in Prostate Cancer
A Phase 2 study testing Abiraterone Acetate, Prednisone and LHRHa in people with Prostate Cancer, run by Cougar Biotechnology, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Abiraterone Acetate, Prednisone and LHRHa
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Mar 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (ANC) > 1,500 and platelet count of > 100,000.
- Normal pituitary and adrenal function
- Patients should be deemed to be candidates for radical prostatectomy.
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-Label, Neoadjuvant Prostate Cancer Trial of Abiraterone Acetate Plus LHRHa Versus LHRHa Alone
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:
Read more
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.
Read the detailed 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.
- Conditions
- Prostate Cancer
- Being tested
- Abiraterone Acetate, Prednisone, LHRHa
- Keywords
- Neoadjuvant Prostate Cancer, Abiraterone Acetate, LHRHa, high risk prostate cancer, Radical prostatectomy, Prednisone, Luteinizing Hormone-Releasing Hormone, LHRH analogue
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abiraterone AcetateDrug
Also called CB7630
1000 mg oral daily for 3 months followed by a prostatectomy.
PrednisoneDrug
5 mg orally daily.
LHRHaDrug
Also called Lupron®, leuprolide, Zoladex®, goserelin
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.
| Study group | Role | What they receive |
|---|---|---|
| AA+LHRHa | Experimental | 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. Receives: Drug: Abiraterone Acetate; Drug: Prednisone; Drug: LHRHa |
| LHRHa | Experimental | 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. Receives: Drug: LHRHa |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the end of Cycle 3 (at radical prostatectomy)
Secondary outcomes (2)
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.
Measured: At the end of Cycle 3 (at radical prostatectomy)
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.
Measured: Cycle 3 Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2010 (estimated)
- Study startDec 2009
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cougar Biotechnology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cougar Biotechnology, Inc. Clinical Trial, Study director, Cougar Biotechnology, Inc.Christopher Logothetis, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01088529
- Sponsor's protocol ID
- CR016945
- Other IDs
- COU-AA-203
- Status last verified
- May 2014
- First submitted
- 15 Mar 2010
- Last updated
- 15 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Neoadjuvant Prostate Cancer Trial of Abiraterone Acetate Plus LHRHa Versus LHRHa Alone
- ClinicalTrials.gov ID
- NCT01088529
- Acronym / sponsor ID
- CR016945
- Conditions
- Prostate Cancer
- Keywords
- Neoadjuvant Prostate Cancer, Abiraterone Acetate, LHRHa, high risk prostate cancer, Radical prostatectomy, Prednisone, Luteinizing Hormone-Releasing Hormone, LHRH analogue
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Cougar Biotechnology, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 17 Mar 2010 (estimated)
- Results
- Posted 9 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AA+LHRHa | Experimental | Drug: Abiraterone Acetate, Drug: Prednisone, Drug: 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. |
| LHRHa | Experimental | Drug: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (ANC) > 1,500 and platelet count of > 100,000.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abiraterone AcetateAlso: CB76301000 mg oral daily for 3 months followed by a prostatectomy. | Drug | AA+LHRHa |
| Prednisone5 mg orally daily. | Drug | AA+LHRHa |
| LHRHaAlso: Lupron®, leuprolide, Zoladex®, goserelinLHRH 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. | Drug | AA+LHRHa, LHRHa |
Primary outcome
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)
The table below shows number of participants in each treatment group with a pathology tumor stage less than or equal to pT2.
2 secondary outcomes
Number of Participants With a Positive Surgical Margin at Radical Prostatectomy
Time frame: At the end of Cycle 3 (at radical prostatectomy)
Number of Participants With Prostate-Specific Antigen Response
Time frame: Cycle 3 Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- NATIONAL CANCER INSTITUTELink provided by the sponsor.
- NATIONAL INSTITUTE OF HEALTHLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cougar Biotechnology, Inc. Clinical Trial study director
Cougar Biotechnology, Inc.
Christopher Logothetis, MD principal investigator
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Abiraterone Acetate, Prednisone and LHRHa in people with Prostate Cancer, run by Cougar Biotechnology, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2014.