Abiraterone Race in Metastatic Castrate-resistant Prostate Cancer

NCT01940276 | Completed Phase 2 Results

• 2 other identifiers: Pro00046383212082PCR2018
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 14

Brief Summary

The primary goal is to prospectively estimate the median radiographic PFS of African American and Caucasian men with mCRPC to abiraterone acetate and prednisone.

Conditions

Prostate Cancer

Keywords

Prostate cancer; metastatic; castrate resistant; abiraterone acetate; prednisone; metastatic prostate cancer

Outcome Measures

Primary Outcomes (1)

• Median Radiographic Progression Free Survival (PFS)

  Time in months from the start of study treatment to the date of first progression according to Prostate Cancer Working Group 2 criteria, or to death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median rPFS was estimated using a Kaplan-Meier curve.

  up to 2 years

Secondary Outcomes (5)

• Change in PSA Response

  Baseline and up to 2 years

• Median Time to PSA Progression

  up to 2 years

• Number of Men With PSA Decline to < 0.1 and < 0.2 ng/ml

  up to 2 years

• Percent of Subjects Experiencing Hypertension

  up to 2 years

• Overall Survival

  up to 3 years

Study Arms (1)

Abiraterone Acetate and Prednisone

EXPERIMENTAL

abiraterone acetate will be administered by the patient at a dose of 1000mg orally once daily with prednisone 5 mg BID in 4-week cycles

Drug: Abiraterone acetate; Drug: Prednisone

Interventions

Abiraterone acetate DRUG

Also known as: Zytiga

Abiraterone Acetate and Prednisone

Prednisone DRUG

Abiraterone Acetate and Prednisone

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male, age ≥ 18 years
• Karnofsky performance status ≥ 70
• Life expectancy of ≥ 12 months
• 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, and should be able to swallow tablets whole, without crushing/chewing tablets
• 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 and sponsor during the study and for 1 week after last dose of abiraterone acetate
• Adequate laboratory parameters
• Histologically confirmed diagnosis of adenocarcinoma of the prostate. Histologic variants of prostate cancer, including neuroendocrine features and small cell carcinoma of the prostate are excluded
• Radiographic evidence of metastatic disease; evaluable non-target lesions and/or bone only metastasis are permitted
• Ongoing ADT using an LHRH agonist (e.g. leuprolide, goserelin) or antagonist (e.g. degarelix) must continue on therapy unless prior bilateral orchiectomy has been performed. Screening serum testosterone must be \<50 ng/dl
• PSA ≥ 2.0 ng/mL
• Evidence of of castration resistant disease on ADT as evidenced by one of the following:
• Absolute rise in PSA of 2.0 ng/mL or greater, minimum 2 consecutive rising PSA levels with an interval of ≥ 1 week between each PSA level, OR
• consecutive PSA levels 50% or greater above the PSA nadir achieved on ADT and separated at least 1 week apart, OR
• CT or MRI based evidence of disease progression (soft tissue, nodal or visceral disease progression) according to modified PCWG2 criteria or modified RECIST 1.1 criteria, or at least 1 new bone scan lesion as compared to the most immediate prior radiologic studies)
• A minimum of 2 weeks elapsed off of antiandrogen therapy prior to start of study drug (i.e. flutamide, nilutamide, bicalutamide)

You may not qualify if:

• Prior treatment with abiraterone acetate or enzalutamide
• Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
• Any chronic medical condition requiring a higher dose of corticosteroid than 5mg prednisone/prednisolone bid
• Have known allergies, hypersensitivity, or intolerance to abiraterone acetate or prednisone or their excipients
• Pathological finding consistent with small cell carcinoma of the prostate
• Symptomatic Liver or visceral organ metastasis
• Have a history of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study agents
• Known brain metastasis
• Prior cytotoxic chemotherapy or biologic therapy for the treatment of CRPC
• Previously treated with ketoconazole for prostate cancer for greater than 7 days
• Prior systemic treatment with an azole drug (e.g. fluconazole, itraconazole) within 4 weeks of Cycle 1, Day 1
• 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.
• Poorly controlled diabetes
• Active or symptomatic viral hepatitis or chronic liver disease
• History of pituitary or adrenal dysfunction

Sponsors & Collaborators

• Duke University: lead

Study Sites (14)

Birmingham VA Medical Center

Birmingham, Alabama, 35233, United States

Location

Tulane Cancer Center

New Orleans, Louisiana, 70112, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Maria Parham Medical Center

Henderson, North Carolina, 27536, United States

Location

Scotland Memorial Hospital

Laurinburg, North Carolina, 28352, United States

Location

Southeastern Regional

Lumberton, North Carolina, 28359, United States

Location

Duke Raleigh Hospital

Raleigh, North Carolina, 27609, United States

Location

W. G. 'Bill' Hefner VA Medical Center

Salisbury, North Carolina, 28144, United States

Location

Johnston Memorial Hospital

Smithfield, North Carolina, 27577, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

Spartanburg Regional

Spartanburg, South Carolina, 29303, United States

Location

Virginia Oncology Associates

Hampton, Virginia, 23666, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Metastasis

Interventions

Abiraterone Acetate; Prednisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes

Results Point of Contact

• Title: Daniel George, MD
• Organization: Duke University

daniel.george@duke.edu

919-668-4615

Study Officials

• Daniel George, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2013
• First Posted: September 12, 2013
• Study Start: October 1, 2013
• Primary Completion: October 8, 2019
• Study Completion: October 8, 2019
• Last Updated: December 9, 2020
• Results First Posted: December 9, 2020

Record last verified: 2020-11

Locations

US (14)