Prostate CancerPhase 2NCT01735396
Abiraterone Acetate Trial in African American Prostate Cancer Patients
A Phase 2 study testing Abiraterone Acetate in people with Prostate Cancer, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
Trial summary
This is a pilot study of abiraterone acetate in African American/Black patients with castration-resistant prostate cancer. The primary objective is to determine the correlation between germline polymorphisms and antitumor activity (as defined by a decline in PSA of ≥ 30%) in African American patients with… 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2012to Mar 2016
- 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
- 1. Have signed an informed consent document indicating that the subjects understands the purpose of and procedures required for the study and are willing to participate in the study
- Be willing/able to adhere to the prohibitions and restrictions specified in this protocol
- Written Authorization for Use and Release of Health and Research Study Information
- African American or Black (by self identification)
- Male aged 18 years and above
- Histologically or cytologically confirmed adenocarcinoma of the prostate
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- Metastatic disease documented by standard imaging
- Progressive prostate cancer based on either rising PSA, new bone metastases, or progression of measurable disease according to PCWG2 12 guidelines.
- Patients in either of the following clinical states will be eligible for enrollment:
- No prior chemotherapy; ii. Patients previously treated with 1-2 prior chemotherapy regimens permitted, one of which must have been included docetaxel
- Surgically or medically castrated, with testosterone levels of < 50 ng/dl.
- Patients previously treated with an anti-androgen must demonstrate progression off of the anti-androgen.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
- Have a baseline serum potassium of ≥ 3.5 mEq/L
- Have aspartate aminotransferase (AST), alanine aminotransferase (ALT), and bilirubin levels < 1.5 x ULN
- Have a serum albumin of ≥ 3.0 g/dL
- Total bilirubin ≤ 1.5 x ULN
- Have a platelet count of ≥ 100,000/μL
- Have an absolute neutrophil count of > 1500 cell/mm3
- Have a calculated creatinine clearance ≥ 60 mL/min
- Have a hemoglobin of ≥ 9.0 g/dL
- Able to swallow the study drug as a whole tablet
- Willing to take abiraterone acetate on an empty stomach; no food should be consumed at least two hours before and for at least one hour after the dose of abiraterone acetate is taken
- Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator during the study and for 1 week after last dose of abiraterone acetate
Who cannot join
- Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
- Known brain metastasis
- Uncontrolled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg) Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment
- Active or symptomatic viral hepatitis or chronic liver disease
- History of pituitary or adrenal dysfunction
- Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class III-IV heart disease or cardiac ejection fraction measurement of < 50% at baseline
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- Administration of an investigational therapeutic within 30 days of screening
- Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements
- Have poorly controlled diabetes
- Have a history of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study agents
- Have a pre-existing condition that warrants long-term corticosteroid use in excess of study dose
- Have known allergies, hypersensitivity, or intolerance to abiraterone acetate or prednisone or their excipients
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Queens Cancer Center, Queens Hospital
New York, New York, 11432
About this study
Official title: A Pilot Study of Abiraterone Acetate in African American/Black Patients With Castration Resistant Prostate Cancer
This is a pilot study of abiraterone acetate in African American/Black patients with castration-resistant prostate cancer. The primary objective is to determine the correlation between germline polymorphisms and antitumor activity (as defined by a decline in PSA of ≥ 30%) in African American patients with castration-resistant prostate cancer treated with abiraterone acetate. Patients will receive abiraterone acetate until the time of disease progression, in the absence of prohibitive toxicities. Patients will be followed for disease progression and survival.
- Conditions
- Prostate Cancer
- Being tested
- Abiraterone Acetate
- Keywords
- African American men, metastatic prostate cancer, castration resistant
- 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 Zytiga
Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
| Study group | Role | What they receive |
|---|---|---|
| Abiraterone Acetate | Experimental | Abiraterone acetate 1000mg orally daily until the time of disease progression, in the absence of prohibitive toxicities. Receives: Drug: Abiraterone Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With ≥ 30% Change in PSA
The primary objective of this study is to determine a correlation between inherited genetic polymorphisms and antitumor activity (as defined by a decline in PSA of ≥ 30%) in AA patients with castration-resistant prostate cancer treated with Abiraterone. The primary endpoint is the percent change in PSA from baseline to 12 weeks. A decline of ≥ 30% will be correlated with germline SNPs.
Measured: baseline and 12 weeks
Secondary outcomes (5)
Response Assessment
Post-treatment changes in measurable disease by RECIST - Response Evaluation Criteria in Solid Tumors Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
Measured: up to 12 weeks
Time to Progression
post-treatment changes in measurable disease by time to disease progression (as per PCWG2 guidelines)
Measured: up to 12 weeks
Bone Scan
post-treatment changes in bone scans (as per PCWG2 guidelines) ("no new lesions" versus "new lesions.")
Measured: up to 12 weeks
Safety of Abiraterone
To determine the safety of abiraterone Adverse events as defined by CTCAE v4. Number of participants with serious adverse events grade 4 or 5
Measured: up to 12 weeks
Testosterone
Post-treatment changes in testosterone
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2012 (estimated)
- Study startDec 2012
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: poor accrual
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Galsky, Icahn School of Medicine at Mount Sinai
- Investigators
- Matthew Galsky, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01735396
- Sponsor's protocol ID
- GCO 12-1727
- Status last verified
- Apr 2017
- First submitted
- 24 Nov 2012
- Last updated
- 12 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Tsao CK, Sfakianos J, Liaw B, Gimpel-Tetra K, Kemeny M, Bulone L, Shahin M, Oh WK, Galsky MD. Phase II Trial of Abiraterone Acetate Plus Prednisone in Black Men With Metastatic Prostate Cancer. Oncologist. 2016 Dec;21(12):1414-e9. doi: 10.1634/theoncologist.2016-0026. Epub 2016 Oct 14.
PubMed 27742908
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Abiraterone Acetate in African American/Black Patients With Castration Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT01735396
- Acronym / sponsor ID
- GCO 12-1727
- Conditions
- Prostate Cancer
- Keywords
- African American men, metastatic prostate cancer, castration resistant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor accrual
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 28 Nov 2012 (estimated)
- Results
- Posted 12 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study of abiraterone acetate in African American/Black patients with castration-resistant prostate cancer. The primary objective is to determine the correlation between germline polymorphisms and antitumor activity (as defined by a decline in PSA of ≥ 30%) in African American patients with castration-resistant prostate cancer treated with abiraterone acetate. Patients will receive abiraterone acetate until the time of disease progression, in the absence of prohibitive toxicities. Patients will be followed for disease progression and survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abiraterone Acetate | Experimental | Drug: Abiraterone AcetateAbiraterone acetate 1000mg orally daily until the time of disease progression, in the absence of prohibitive toxicities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 1. Have signed an informed consent document indicating that the subjects understands the purpose of and procedures required for the study and are willing to participate in the study
- Be willing/able to adhere to the prohibitions and restrictions specified in this protocol
- Written Authorization for Use and Release of Health and Research Study Information
- African American or Black (by self identification)
- Male aged 18 years and above
Key exclusion criteria (12 listed)
- Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
- Known brain metastasis
- Uncontrolled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg) Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment
- Active or symptomatic viral hepatitis or chronic liver disease
- History of pituitary or adrenal dysfunction
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: ZytigaAbiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily | Drug | Abiraterone Acetate |
Primary outcome
Number of Participants With ≥ 30% Change in PSA
Time frame: baseline and 12 weeks
The primary objective of this study is to determine a correlation between inherited genetic polymorphisms and antitumor activity (as defined by a decline in PSA of ≥ 30%) in AA patients with castration-resistant prostate cancer treated with Abiraterone. The primary endpoint is the percent change in PSA from baseline to 12 weeks. A decline of ≥ 30% will be correlated with germline SNPs.
5 secondary outcomes
Response Assessment
Time frame: up to 12 weeks
Time to Progression
Time frame: up to 12 weeks
Bone Scan
Time frame: up to 12 weeks
Safety of Abiraterone
Time frame: up to 12 weeks
Testosterone
Time frame: up to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27742908Tsao CK, Sfakianos J, Liaw B, Gimpel-Tetra K, Kemeny M, Bulone L, Shahin M, Oh WK, Galsky MD. Phase II Trial of Abiraterone Acetate Plus Prednisone in Black Men With Metastatic Prostate Cancer. Oncologist. 2016 Dec;21(12):1414-e9. doi: 10.1634/theoncologist.2016-0026. Epub 2016 Oct 14.
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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.
Matthew Galsky, MD principal investigator
Icahn School of Medicine at Mount Sinai
2 sites 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 in people with Prostate Cancer, run by Icahn School of Medicine at Mount Sinai at 2 sites 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 24 inclusion and 12 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: stopped early, as of the sponsor's last update on 12 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 12 May 2017). 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 ≥ 30% Change in PSA (time frame: baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01735396, which also lists 1 linked publication.
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 12 May 2017.