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Abiraterone Acetate for Castrate Resistant Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01961843
Recruitment Status : Active, not recruiting
First Posted : October 11, 2013
Last Update Posted : April 14, 2020
Sponsor:
Information provided by (Responsible Party):
Richard J. Lee, MD, Massachusetts General Hospital

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Abiraterone Drug: Prednisone Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2013
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Abiraterone acetate with Prednisone
1000 mg Abiraterone daily by mouth, 4 x 250 mg tablets Prednisone administered as 5 mg orally twice a day
Drug: Abiraterone
Abiraterone acetate is an orally bioavailable inhibitor of steroid synthesis, specifically testosterone synthesis.
Other Names:
  • Abiraterone acetate
  • Zytiga

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




Primary Outcome Measures :
  1. Assessment of AR signaling in CTCs and correlation with response [ Time Frame: 2 years ]
    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.


Secondary Outcome Measures :
  1. Change in number and proliferative fraction of CTCs with abiraterone treatment [ Time Frame: 2 years ]
    The investigators will examine the number number and proliferative fraction of CTCs found in the blood of subjects prior to and during abiraterone treatment. Proliferation will be measured by Ki-67 staining. Baseline and post-treatment change in Ki-67 proliferative index will be correlated with other measure of clinical response to abiraterone.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
  • Bicalutamide, nilutamide within 6 weeks of Cycle 1, Day 1
  • 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
  • Administration of an investigational therapeutic within 30 days of Cycle 1, Day 1

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01961843


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Richard Lee, MD, PhD Massachusetts General Hospital
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Responsible Party: Richard J. Lee, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01961843    
Other Study ID Numbers: 13-209
First Posted: October 11, 2013    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Richard J. Lee, MD, Massachusetts General Hospital:
Castration Resistant
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Prednisone
Abiraterone Acetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Cytochrome P-450 Enzyme Inhibitors