Abiraterone Acetate in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer

NCT01503229 | Completed Phase 2 Results

• 4 other identifiers: 7639NCI-2011-037450801P30CA015704
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well abiraterone acetate works in treating patients with hormone-resistant prostate cancer that has spread from the primary site (place where it started) to other places in the body (metastatic). Abiraterone acetate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Conditions

Hormone-Resistant Prostate Cancer; Metastatic Prostate Carcinoma; Recurrent Prostate Carcinoma; Stage IV Prostate Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Change in Tissue Testosterone and Dihydrotestosterone

  Tissue testosterone will be measured in biopsy tissues

  From baseline to week 4

Study Arms (1)

Treatment (abiraterone acetate and prednisone)

EXPERIMENTAL

Patients receive abiraterone acetate orally once daily and prednisone orally twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: Abiraterone Acetate; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Drug: Prednisone

Interventions

Abiraterone Acetate DRUG

Given by mouth

Also known as: CB7630, Zytiga

Treatment (abiraterone acetate and prednisone)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (abiraterone acetate and prednisone)

Pharmacological Study OTHER

Correlative studies

Treatment (abiraterone acetate and prednisone)

Prednisone DRUG

Given PO

Also known as: .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl, Dacortin, DeCortin, Decortisyl, Decorton, Delta 1-Cortisone, Delta-Dome, Deltacortene, Deltacortisone, Deltadehydrocortisone, Deltasone, Deltison, Deltra, Econosone, Lisacort, Meprosona-F, Metacortandracin, Meticorten, Ofisolona, Orasone, Panafcort, Panasol-S, Paracort, PRED, Predicor, Predicorten, Prednicen-M, Prednicort, Prednidib, Prednilonga, Predniment, Prednisonum, Prednitone, Promifen, Servisone, SK-Prednisone

Treatment (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:

• 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
• Written authorization for use and release of health and research study information has been obtained
• Be willing/able to adhere to the prohibitions and restrictions specified in this protocol
• Able to swallow the study drug whole as a 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 and sponsor during the study and for 1 week after last dose of abiraterone acetate
• Histologically proven adenocarcinoma of the prostate
• Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
• Metastatic castration resistant prostate cancer as defined by serum testosterone \< 50 ng/ml and one of the following:
• Prostate specific antigen (PSA) level of at least 2 ng/ml that has risen on at least 2 successive occasions at least 1 week apart
• Evaluable disease progression by modified RECIST (Response Evaluation Criteria in Solid Tumors)
• Progression of metastatic bone disease on bone scan with \> 2 new lesions
• Maintenance of Lupron or antagonist unless previously treated with orchiectomy
• The presence of metastatic disease amenable to computed tomography (CT) or ultrasound guided biopsy; this may include thoracolumbar vertebral bodies, pelvis, femur or humerus, or soft tissue or nodal metastasis amenable to biopsy (excluding lung or pleural lesions)
• Patients may have received secondary hormonal manipulations (excluding prior abiraterone acetate, MDV3100 or TAK700) or up to two lines of chemotherapy; all prior therapy except Lupron must have been discontinued for more than 4 weeks before enrollment

You may not qualify if:

• Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
• Patients who are currently receiving active therapy for other neoplastic disorders will not be eligible
• Patients with histologic evidence of small cell carcinoma of the prostate will not be eligible
• Known brain metastasis
• Uncontrolled hypertension (systolic blood pressure \[BP\] \>= 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 II-IV heart disease or cardiac ejection fraction measurement of \< 50 % at baseline
• Atrial fibrillation, or other cardiac arrhythmia requiring medical therapy
• Administration of an investigational therapeutic within 30 days of screening
• Patients with dementia/psychiatric illness/social situations that would limit compliance with study requirements or would prohibit the understanding and/or giving of informed consent will not be eligible
• Patients with 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
• Patients requiring therapeutic anticoagulation (e.g., warfarin, dabigatran, heparin, or low molecular weight heparins \[Lovenox, dalteparin\])
• Patients with poorly controlled diabetes
• Patients with a history of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study agents

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Abiraterone Acetate; Prednisone; deltacortene; prednylidene

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Bruce Montgomery
• Organization: University of Washington

rbmontgo@uw.edu

206-598-0860

Study Officials

• Robert Montgomery

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 27, 2011
• First Posted: January 2, 2012
• Study Start: December 1, 2012
• Primary Completion: March 12, 2020
• Study Completion: March 12, 2020
• Last Updated: May 14, 2021
• Results First Posted: May 14, 2021

Record last verified: 2021-04

Locations

US (1)