Abiraterone Acetate for Castrate Resistant Prostate Cancer

NCT01961843 | Completed DMC

• 1 other identifier: 13-209
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is a Pilot clinical trial. Pilot clinical trials often examine new tests (such as laboratory or radiology tests) in patients who receive either standard cancer treatments or new treatments that have been well-tested in many patients on other trials. It is often difficult to determine how prostate cancer is going to behave when a new treatment is started. Physicians have no way to predict how a patient's tumor will respond to treatment. Although scientists have learned about changes that happen in tumors due to treatment, it is difficult to get cells from tumors because a biopsy (surgical procedure to remove a small piece of tissue) is needed. This study will evaluate a method to detect tumor cells that are circulating in the blood without getting a biopsy. It is known that tumors shed a small number of cells into the blood stream every day. These are called circulating tumor cells or CTCs. Some early studies indicate the amount and type of CTCs in the blood can help determine the status of the tumor itself and the way it is responding to treatment. In this study, the investigators will examine protein levels in CTCs from patients' blood at different times before and after drug treatment to determine if they correlate with response to the drug. The new test will not affect whether subjects continue on the study drug. Abiraterone acetate is a marketed drug that has been studied for the treatment of metastatic CRPC. It blocks the remaining or residual male hormones in the body that may be helping prostate cancer to grow. Abiraterone acetate is now FDA-approved for patients with metastatic CRPC who have not yet received docetaxel chemotherapy. Abiraterone acetate has been used by a large number of participants in previous clinical trials. In most of these trials, participants with CRPC have been given abiraterone acetate with prednisone. Prednisone is a man-made hormone commonly referred to as a steroid. Prednisone has been approved in the US, Canada, and Europe for various disorders and diseases, such as asthma, Lupus and chronic obstructive lung disease. The combination of prednisone with abiraterone acetate has been approved for the treatment of CRPC. Prednisone together with abiraterone acetate will be given in this study in order to reduce or eliminate some side effects. Investigators will use patients' blood samples to study the genes (also called DNA) and their products (RNA and proteins) found in CTCs.

Conditions

Prostate Cancer

Keywords

Castration Resistant

Outcome Measures

Primary Outcomes (1)

• Assessment of AR signaling in CTCs and correlation with response

  To assess AR signaling in CTCs and correlate with PSA response and/or measurable disease response, if applicable. The investigators have developed a protein-based test to evaluate whether the AR signal is active ("AR-on") or inactive ("AR-off") or indeterminate ("AR-mixed"). The investigators will examine the AR signaling present in CTCs prior to and during abiraterone therapy. By correlating the baseline or post-treatment change in AR signaling with other measures of clinical benefit, the investigators aim to evaluate the use of AR signaling in CTCs to predict response to abiraterone. This may be applicable to other agents that target AR signaling.

  2 years

Secondary Outcomes (1)

• Change in number and proliferative fraction of CTCs with abiraterone treatment

  2 years

Study Arms (1)

Abiraterone acetate with Prednisone

EXPERIMENTAL

1000 mg Abiraterone daily by mouth, 4 x 250 mg tablets Prednisone administered as 5 mg orally twice a day

Drug: Abiraterone; Drug: Prednisone

Interventions

Abiraterone DRUG

Abiraterone acetate is an orally bioavailable inhibitor of steroid synthesis, specifically testosterone synthesis.

Also known as: Abiraterone acetate, Zytiga

Abiraterone acetate with Prednisone

Prednisone DRUG

Prednisone is a synthetic corticosteroid that is co-administered with abiraterone acetate to offset the hypokalemia and hypertension side effects of abiraterone acetate.

Abiraterone acetate with Prednisone

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed adenocarcinoma of the prostate
• Able to swallow the study drug whole as a tablet
• Willing to take abiraterone on an empty stomach
• Willing to use a method of birth control with adequate barrier protection
• Metastatic disease as documented by positive bone scan or metastatic lesions other than liver or visceral metastasis on CT, MRI
• Asymptomatic or mildly symptomatic from prostate cancer
• Surgically or medically castrated
• Previous anti-androgen therapy and progression after withdrawal
• Life expectancy of at least 6 months

You may not qualify if:

• Active infection or other medical condition that would make corticosteroid use contraindicated
• Uncontrolled hypertension
• Severe hepatic impairment
• 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 NYHA Class III or IV heart disease
• 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 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
• Pathologic finding consistent with small cell carcinoma of the prostate
• Liver, visceral organ or brain metastasis
• Prior cytotoxic chemotherapy or biologic therapy for the treatment of CRPC
• Radiation therapy for treatment of the primary tumor within 6 weeks of Cycle 1, Day 1
• Radiation or radionuclide therapy for treatment of metastatic CRPC tumor within 2 or 6 weeks, respectively, of Cycle 1, Day 1

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

abiraterone; 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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Richard Lee, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• 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: October 8, 2013
• First Posted: October 11, 2013
• Study Start: January 14, 2014
• Primary Completion: April 6, 2023
• Study Completion: May 31, 2024
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)