Abiraterone Acetate Trial in African American Prostate Cancer Patients

• Sponsor: Icahn School of Medicine at Mount Sinai (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01735396
• Collaborator: (none)
• Enrollment: 11
• Locations: 2
• Arm: 1
• Duration (Months): 39
• Patients Per Site: 5.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief 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 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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: Abiraterone Acetate	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 11 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Pilot Study of Abiraterone Acetate in African American/Black Patients With Castration Resistant Prostate Cancer
• Study Start Date: Dec 1, 2012
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Abiraterone Acetate Abiraterone acetate 1000mg orally daily until the time of disease progression, in the absence of prohibitive toxicities.	Drug: Abiraterone Acetate; Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily; Other Names: Zytiga

Outcome Measures

Primary Outcome Measures

1. Number of Participants With ≥ 30% Change in PSA [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.

Secondary Outcome Measures

1. Response Assessment [up to 12 weeks]

   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

2. Time to Progression [up to 12 weeks]

   post-treatment changes in measurable disease by time to disease progression (as per PCWG2 guidelines)

3. Bone Scan [up to 12 weeks]

   post-treatment changes in bone scans (as per PCWG2 guidelines) ("no new lesions" versus "new lesions.")

4. Safety of Abiraterone [up to 12 weeks]

   To determine the safety of abiraterone Adverse events as defined by CTCAE v4. Number of participants with serious adverse events grade 4 or 5

5. Testosterone [up to 12 weeks]

   Post-treatment changes in testosterone

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

• 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:

1. 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

Exclusion Criteria:

• 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

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029
2	Queens Cancer Center, Queens Hospital	New York	New York	United States	11432

Sponsors and Collaborators

• Icahn School of Medicine at Mount Sinai

Investigators

• Principal Investigator: Matthew Galsky, MD, Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mt. Sinai Tisch Cancer Institute

Publications

None provided.

• Responsible Party: Matthew Galsky, Associate Professor, Icahn School of Medicine at Mount Sinai
• ClinicalTrials.gov Identifier: NCT01735396
• Other Study ID Numbers: GCO 12-1727
• First Posted: Nov 28, 2012
• Last Update Posted: May 12, 2017
• Last Verified: Apr 1, 2017

• Keywords provided by Matthew Galsky, Associate Professor, Icahn School of Medicine at Mount Sinai: African American men; metastatic prostate cancer; castration resistant
• Additional relevant MeSH terms: Prostatic Neoplasms; Abiraterone Acetate

Study Results

Participant Flow

Recruitment Details	Recruitment began in Dec 2012, with enrollment from April 2014 to March 2016.

Arm/Group Title	Abiraterone Acetate
Arm/Group Description	Abiraterone acetate 1000mg orally daily until the time of disease progression, in the absence of prohibitive toxicities. Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
Period Title: Overall Study
STARTED	11
COMPLETED	10
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Abiraterone Acetate
Arm/Group Description	Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
Overall Participants	11
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	66
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	11 100%
Number of prior systemic therapies (prior therapies) [Median (Full Range) ]
Median (Full Range) [prior therapies]	3
Performance Status: ECOG (Count of Participants)
ECOG 0	8 72.7%
ECOG 1	3 27.3%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With ≥ 30% Change in PSA
Description	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.
Time Frame	baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Abiraterone Acetate
Arm/Group Description	Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
Measure Participants	10
Count of Participants [Participants]	9 81.8%

2. Secondary Outcome

Title	Response Assessment
Description	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
Time Frame	up to 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Abiraterone Acetate
Arm/Group Description	Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
Measure Participants	10
PR	9 81.8%
SD	1 9.1%

3. Secondary Outcome

Title	Time to Progression
Description	post-treatment changes in measurable disease by time to disease progression (as per PCWG2 guidelines)
Time Frame	up to 12 weeks

Outcome Measure Data

Analysis Population Description

data not collected

Arm/Group Title	Abiraterone Acetate
Arm/Group Description	Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
Measure Participants	0

4. Secondary Outcome

Title	Bone Scan
Description	post-treatment changes in bone scans (as per PCWG2 guidelines) ("no new lesions" versus "new lesions.")
Time Frame	up to 12 weeks

Outcome Measure Data

Analysis Population Description

data not collected

Arm/Group Title	Abiraterone Acetate
Arm/Group Description	Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
Measure Participants	0

5. Secondary Outcome

Title	Safety of Abiraterone
Description	To determine the safety of abiraterone Adverse events as defined by CTCAE v4. Number of participants with serious adverse events grade 4 or 5
Time Frame	up to 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Abiraterone Acetate
Arm/Group Description	Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
Measure Participants	10
Count of Participants [Participants]	0 0%

6. Secondary Outcome

Title	Testosterone
Description	Post-treatment changes in testosterone
Time Frame	up to 12 weeks

Outcome Measure Data

Analysis Population Description

data not collected

Arm/Group Title	Abiraterone Acetate
Arm/Group Description	Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
Measure Participants	0

Adverse Events

Arm/Group Title	Abiraterone Acetate
Arm/Group Description	Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
All Cause Mortality
	Abiraterone Acetate
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Serious Adverse Events
	Abiraterone Acetate
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Other (Not Including Serious) Adverse Events
	Abiraterone Acetate
	Affected / at Risk (%)	# Events
Total	10/10 (100%)
Blood and lymphatic system disorders
Platelet count decreased	2/10 (20%)
Lymphocyte count decreased	4/10 (40%)
General disorders
Fatigue	7/10 (70%)
Hot flashes	4/10 (40%)
Nausea	4/10 (40%)
Vomiting	4/10 (40%)
Cough	3/10 (30%)
Diarrhea	2/10 (20%)
Anorexia	3/10 (30%)
Metabolism and nutrition disorders
Hypocalcemia	2/10 (20%)
Hypokalemia	2/10 (20%)
Alkaline phosphatase level increased	7/10 (70%)
Hypophosphatemia	4/10 (40%)
Hyperglycemia	5/10 (50%)
Hypoalbuminemia	2/10 (20%)
Aspartate aminotransferase level increased	3/10 (30%)
Alanine aminotransferase level increased	2/10 (20%)
Musculoskeletal and connective tissue disorders
Muscle weakness in lower limb	2/10 (20%)
Back pain	3/10 (30%)
Renal and urinary disorders
Urinary incontinence	3/10 (30%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.