Prostate CancerNCT01961843
Abiraterone Acetate for Castrate Resistant Prostate Cancer
A study testing Abiraterone and Prednisone in people with Prostate Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Abiraterone and Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2014to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Surgically or medically castrated
- Previous anti-androgen therapy and progression after withdrawal
- Life expectancy of at least 6 months
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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
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.
Read more
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.
Read the detailed description
If a patient agrees to participate in this research study, he will be asked to undergo some screening tests and procedures to confirm eligibility. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out the patient does not take part in the research study. These tests and procedures include: a medical history, physical exam, performance status, EKG, MUGA scan, bone scan, evaluation of the patient's disease, blood tests and a urine test. If these tests show that the patient is eligible to participate in the research study, he will begin the study treatment. If the patient does not meet the eligibility criteria, he will not be able to participate.
Once confirmed eligible to participate in the study, the patient will be started on the treatment. Patients will be seen in an outpatient setting. All patients will receive the study drugs, abiraterone acetate and prednisone. For the purposes of this description, study treatment will refer to abiraterone acetate in combination with prednisone.
Patients will take 4 tablets of abiraterone acetate by mouth daily. Patients will also take 1 tablet of prednisone by mouth twice a day. Patients will be given a study diary which includes instructions on how and when to take the study medication.
During the first two months in the study, patients will make about 3 visits to the clinic. Afterwards, patients will visit the clinic about once a month.
This study uses bone scans to assess worsening of subjects' prostate cancer (tumor progression) in the bones. Because arthritis can cause spots to appear on the bone scans, the scan is repeated a few weeks later. Cancer spots remain the same, but arthritis spots may disappear. Prostate Specific Antigen (PSA) tests can also be unreliable in the first few weeks after starting any new prostate cancer therapy. This is because the death of prostate cancer cells as a result of a new treatment can release PSA leading to an initial higher level in your blood. Such early rises in PSA can be mistaken for progression of a patient's cancer.
Cancer treatments can be divided into periods of time called cycles. A cycle in this study will last 28 days. At the start of each cycle of treatment, patients will be asked to visit the clinic to have regular pre-scheduled checkups and lab assessments. During Cycle 1 of this study, patients will be asked to come to the clinic twice for assessments, on Day 1 and Day 15. At these visits the study staff will talk to patients about the study in greater detail, perform all study visit procedures and provide the study treatment. The staff may also perform more tests and evaluations if needed.
If a subject continues to qualify for the study after Cycle 1, he will undergo a medical review, physical exam and blood sample on Day 1 of each cycle. Throughout the study, patients will be asked if you are experiencing any side effects. Subjects will be responsible for keeping your doctor informed if they feel they are having a reaction to the study treatment. In addition, subjects will be responsible for taking the medications on a daily basis as directed. It is very important to inform the treating clinician of any missed doses and the reasons why doses were missed, at each study visit. Patients will also be responsible for returning unused medication or the empty bottle at each study visit.
On Day 1 of Cycles 4, 7, 10 and every third cycle for as long as patients remain on study a blood sample for the CTC tests (about 2 tablespoons) will be collected. The following additional procedures will be done on Day 1 of Cycles 4, 7, 10 and every third cycle thereafter, and at Treatment Discontinuation: CT or MRI of abdomen and pelvis and bone scans.
After the final dose of study drug, patients will return for an End of Study Treatment Visit (15-28 days from treatment discontinuation). The tests completed at this end of study visit are the same as Cycle 1 Day 1.
- Conditions
- Prostate Cancer
- Being tested
- Abiraterone, Prednisone
- Keywords
- Castration Resistant
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbirateroneDrug
Also called Abiraterone acetate, Zytiga
Abiraterone acetate is an orally bioavailable inhibitor of steroid synthesis, specifically testosterone synthesis.
PrednisoneDrug
Prednisone is a synthetic corticosteroid that is co-administered with abiraterone acetate to offset the hypokalemia and hypertension side effects of abiraterone acetate.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Abiraterone; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
Change in number and proliferative fraction of CTCs with abiraterone treatment
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2013 (estimated)
- Study start14 Jan 2014
- Primary completion6 Apr 2023
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard J. Lee, MD, Massachusetts General Hospital
- Investigators
- Richard Lee, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01961843
- Sponsor's protocol ID
- 13-209
- Status last verified
- Nov 2025
- First submitted
- 8 Oct 2013
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01961843
- Acronym / sponsor ID
- 13-209
- Conditions
- Prostate Cancer
- Keywords
- Castration Resistant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 14 Jan 2014
- Primary completion
- 6 Apr 2023 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 11 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
If a patient agrees to participate in this research study, he will be asked to undergo some screening tests and procedures to confirm eligibility. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out the patient does not take part in the research study. These tests and procedures include: a medical history, physical exam, performance status, EKG, MUGA scan, bone scan, evaluation of the patient's disease, blood tests and a urine test. If these tests show that the patient is eligible to participate in the research study, he will begin the study treatment. If the patient does not meet the eligibility criteria, he will not be able to participate.
Once confirmed eligible to participate in the study, the patient will be started on the treatment. Patients will be seen in an outpatient setting. All patients will receive the study drugs, abiraterone acetate and prednisone. For the purposes of this description, study treatment will refer to abiraterone acetate in combination with prednisone.
Patients will take 4 tablets of abiraterone acetate by mouth daily. Patients will also take 1 tablet of prednisone by mouth twice a day. Patients will be given a study diary which includes instructions on how and when to take the study medication.
During the first two months in the study, patients will make about 3 visits to the clinic. Afterwards, patients will visit the clinic about once a month.
This study uses bone scans to assess worsening of subjects' prostate cancer (tumor progression) in the bones. Because arthritis can cause spots to appear on the bone scans, the scan is repeated a few weeks later. Cancer spots remain the same, but arthritis spots may disappear. Prostate Specific Antigen (PSA) tests can also be unreliable in the first few weeks after starting any new prostate cancer therapy. This is because the death of prostate cancer cells as a result of a new treatment can release PSA leading to an initial higher level in your blood. Such early rises in PSA can be mistaken for progression of a patient's cancer.
Cancer treatments can be divided into periods of time called cycles. A cycle in this study will last 28 days. At the start of each cycle of treatment, patients will be asked to visit the clinic to have regular pre-scheduled checkups and lab assessments. During Cycle 1 of this study, patients will be asked to come to the clinic twice for assessments, on Day 1 and Day 15. At these visits the study staff will talk to patients about the study in greater detail, perform all study visit procedures and provide the study treatment. The staff may also perform more tests and evaluations if needed.
If a subject continues to qualify for the study after Cycle 1, he will undergo a medical review, physical exam and blood sample on Day 1 of each cycle. Throughout the study, patients will be asked if you are experiencing any side effects. Subjects will be responsible for keeping your doctor informed if they feel they are having a reaction to the study treatment. In addition, subjects will be responsible for taking the medications on a daily basis as directed. It is very important to inform the treating clinician of any missed doses and the reasons why doses were missed, at each study visit. Patients will also be responsible for returning unused medication or the empty bottle at each study visit.
On Day 1 of Cycles 4, 7, 10 and every third cycle for as long as patients remain on study a blood sample for the CTC tests (about 2 tablespoons) will be collected. The following additional procedures will be done on Day 1 of Cycles 4, 7, 10 and every third cycle thereafter, and at Treatment Discontinuation: CT or MRI of abdomen and pelvis and bone scans.
After the final dose of study drug, patients will return for an End of Study Treatment Visit (15-28 days from treatment discontinuation). The tests completed at this end of study visit are the same as Cycle 1 Day 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abiraterone acetate with Prednisone | Experimental | Drug: Abiraterone, Drug: Prednisone1000 mg Abiraterone daily by mouth, 4 x 250 mg tablets Prednisone administered as 5 mg orally twice a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AbirateroneAlso: Abiraterone acetate, ZytigaAbiraterone acetate is an orally bioavailable inhibitor of steroid synthesis, specifically testosterone synthesis. | Drug | Abiraterone acetate with Prednisone |
| PrednisonePrednisone is a synthetic corticosteroid that is co-administered with abiraterone acetate to offset the hypokalemia and hypertension side effects of abiraterone acetate. | Drug | Abiraterone acetate with Prednisone |
Primary outcome
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.
1 secondary outcome
Change in number and proliferative fraction of CTCs with abiraterone treatment
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Lee, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abiraterone and Prednisone in people with Prostate Cancer, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of AR signaling in CTCs and correlation with response (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.