NCT01961843Completed
Abiraterone Acetate for Castrate Resistant Prostate Cancer
Investigator-Initiated, Pilot Translational Study of Circulating Tumor Cells to Identify Predictive Factors of Response to Abiraterone Acetate in Men With Castration-Resistant Prostate Cancer
Source: ClinicalTrials.gov · Last updated 25 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 8 Oct 2013
- Start date
- 14 Jan 2014
- Primary completion date
- 6 Apr 2023
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Prostate cancer
- NCT number
- NCT01961843
What you commit to
- Study type: Interventional
- Participants enrolled: 40
- From 14 Jan 2014 to the primary completion date, 6 Apr 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Previous treatment with ketoconazole for prostate cancer for greater than 7 days
- Prior systemic treatment with an azole drug
- Prior flutamide treatment within 4 weeks of Cycle 1, Day 1
Other illness
- 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
- Active or symptomatic viral hepatitis or chronic liver disease
- History of a different malignancy except for the following circumstances: disease-free for at least 5 years and deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: basal cell or squamous cell carcinoma of the skin
Other
- Pathologic finding consistent with small cell carcinoma of the prostate
- Liver, visceral organ or brain metastasis
- Bicalutamide, nilutamide within 6 weeks of Cycle 1, Day 1
- Administration of an investigational therapeutic within 30 days of Cycle 1, Day 1
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.