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Castration-resistant Prostate CancerPhase 2NCT02025010

Study of Abiraterone Acetate Without Exogenous Glucocorticoids in Men With Castration-resistant Prostate Cancer

A Phase 2 study testing abiraterone acetate in people with Castration-resistant Prostate Cancer, run by Dana-Farber Cancer Institute at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is comparing the safety and effectiveness of abiraterone acetate alone, followed by the addition of prednisone (when the participant's disease worsens or the physician feels it would lessen symptoms of toxicity) versus the current approved treatment regimen which involves the concomitant use of prednisone… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Castration-resistant Prostate Cancer
What is being tested?
abiraterone acetate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
8 sitesUnited States
Study dates
27 Jan 2014to 7 Apr 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Participants must meet the following criteria on screening examination to be eligible to participate in the study:
  • Be a male ≥ 18 years of age.
  • Participants must have histologically or cytologically confirmed adenocarcinoma of the prostate without >50% neuroendocrine differentiation or small cell histology.
  • Participants must have progressive disease as defined by one or more of the following:
  • Castrate resistant disease as defined by Prostate cancer working Group (PCWG).[30] Participants must have a rise in PSA on two successive determinations at least one week apart and PSA levels ≥ 2 ng/ml (only the screening PSA needs to be ≥ 2 ng/ml) and testosterone levels < 50 ng/dL.
  • Soft tissue progression defined by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
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  • Bone disease progression defined by Prostate Cancer Clinical Trials Working Group 2 (PCWG2) with two or more new lesions on bone scan.[30]
  • Castration-resistant prostate cancer (CRPC) with metastatic disease with at least one site of metastatic disease must be amenable to needle biopsy. Soft tissue biopsy sites include: lymph node or visceral metastases. Bone sites include lumbar vertebrae, pelvic bones and long bones. Excluded sites are thoracic, cervical vertebrae, skull and rib lesions. Biopsy site will be selected with guidance of interventional radiologist determining best site to optimize balance of obtaining useful tissue for analysis and minimizing risk.
  • Participants without orchiectomy must be maintained on Luteinizing hormone-releasing hormone (LHRH) agonist/antagonist therapy.
  • Participants may have had any number of previous hormonal therapies (antiandrogens including enzalutamide, steroids, estrogens, finasteride, dutasteride, ketoconazole) provided these were discontinued ≥ 4 weeks before starting the trial.
  • Participants may have had up to two previous cytotoxic therapeutic regimens provided these were discontinued ≥ 4 weeks before starting the trial.
  • At least a 4 week interval from previous prostate cancer treatment other than LHRH agonist/antagonist therapy or bisphosphonates to the start of protocol therapy.
  • Participants receiving bisphosphonates therapy can be maintained on this therapy. If participants have not started bisphosphonates, it is recommended that they start treatment after the first biopsy.
  • Eastern Cooperative Oncology Group (ECOG) performance status < 2 (Karnofsky >60%, see Appendix A).
  • Participants must have normal organ and marrow function as defined below:
  • Platelets > 50,000/microliter (mcL)
  • Serum potassium ≥ 3.5 mmol/L (independent of potassium supplementation)
  • Serum albumin ≥ 3.0 g/dL
  • Aspartate transaminase (AST), Alanine transaminase (ALT), and total bilirubin ≤ 1.5 x Institutional Upper Limit of Normal (ULN).
  • Partial thromboplastin time (PTT) ≤ 60, International Normalized Ratio (INR) ≤ 1.5 Institutional ULN unless on warfarin therapy (investigator would need to determine if safe for participant to stop warfarin prior to biopsy)
  • Controlled blood pressure (systolic blood pressure < 140 and diastolic blood pressure <90) on no more than three anti-hypertensive agents. Drug formulations containing two or more anti-hypertensive agents will be counted based on the number of active agents in each formulation.
  • EKG showing a normal QTc interval (QTc < 450 msec).
  • Left ventricular ejection fraction ≥ 50%.
  • 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.
  • Be willing/able to adhere to the prohibitions and restrictions specified in this protocol.
  • Written Authorization for Use and Release of Health and Research Study Information (US sites only) has been obtained.
  • Able to swallow the study drug whole as a tablet.
  • Willing to take AA on an empty stomach; no food should be consumed at least two hours before and for at least one hour after the dose AA is taken.
  • Participants 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 PI during the treatment period and for 1 week after last dose of AA.

Who cannot join

  • Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
  • Uncontrolled illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or would make prednisone/prednisolone (corticosteroid) use contraindicated.
  • 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 III or IV heart disease or cardiac ejection fraction measurement of < 50 % at baseline.
  • Thromboembolism within 6 months of Cycle 1, Day 1.
  • Severe hepatic impairment (Child-Pugh Class C).
  • History of pituitary or adrenal dysfunction.
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  • Poorly controlled diabetes.
  • History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study drug.
  • Have a pre-existing condition that warrants long-term corticosteroid use.
  • Individuals with a history of a different malignancy are ineligible except for the following circumstances: 1) individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy, or 2) individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: superficial bladder cancer, basal cell or squamous cell carcinoma of the skin.
  • Known brain metastasis.
  • Prior therapy with AA.
  • Have known allergies, hypersensitivity, or intolerance to AA or prednisone or their excipients.
  • Surgery or local prostatic intervention within 30 days of the first dose. In addition, any clinically relevant issues from the surgery must have resolved prior to Cycle 1, Day 1.
  • Major surgery or radiation therapy within 4 weeks of Cycle 1, Day 1.
  • Strontium-89 or samarium-153 therapy within 4 weeks of Cycle 1, Day 1.
  • Radiotherapy, chemotherapy or immunotherapy within 4 weeks, or single fraction of palliative radiotherapy within 14 days of administration of Cycle 1, Day 1.
  • Current enrollment in an investigational drug or device study or participation in such a study within 30 days of Cycle 1, Day 1.
  • Any acute toxicities due to prior chemotherapy and/or radiotherapy that have not resolved to a NCI Common Toxicity Criteria for Adverse Effects (CTCAE) version 4 grade of ≤ 1. Chemotherapy induced alopecia and grade 2 peripheral neuropathy are allowed.
  • Condition or situation which, in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with participant's participation in the study.
  • Individuals not willing to comply with the procedural requirements of this protocol.
  • HIV-positive individuals on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with AA.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Memorial Sloan Kettering Cancer Center Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Memorial Sloan Kettering Cancer Center Commack

    Commack, New York, 11725

  • Memorial Sloan Kettering Cancer Center West Harrison

    Harrison, New York, 10604

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • Memorial Sloan Kettering Cancer Center Rockville Centre

    Rockville Centre, New York, 11510

  • Memorial Sloan Kettering Cancer Center Sleepy Hollow

    Sleepy Hollow, New York, 10591

Other trials in United States

About this study

Official title: Phase II Clinical Trial of Abiraterone Acetate Without Exogenous Glucocorticoids in Men With Castration-resistant Prostate Cancer With Correlative Assessment of Hormone Intermediates.

This study is comparing the safety and effectiveness of abiraterone acetate alone, followed by the addition of prednisone (when the participant's disease worsens or the physician feels it would lessen symptoms of toxicity) versus the current approved treatment regimen which involves the concomitant use of prednisone in conjunction with abiraterone acetate. Additionally, this study is also examining why participants stop responding to treatment with abiraterone acetate by evaluating blood and tissue.

Read the detailed description

Participants will be treated with abiraterone acetate (AA) in 28-day cycles. Participants will be monitored (weekly for the first two cycles, then on Day 1 of each subsequent cycle) for symptoms of persistent or severe mineralocorticoid excess (including hypertension, hypokalemia).

For participants who experience symptoms of persistent or severe hypertension or hypokalemia as detailed in the above schema, prednisone 5 mg by mouth twice daily will be added. We will monitor for other symptoms of AA toxicity to include fluid retention and fatigue.

For participations who tolerate AA monotherapy without the addition of prednisone to manage symptoms of persistent or severe mineralocorticoid excess, prednisone 5 mg by mouth twice daily will be added at Prostate Specific Antigen (PSA) progression. Participants will be continued on study until symptomatic or radiographic progression or taken off study for another reason as detailed in protocol.

Being tested
abiraterone acetate
Keywords
Castration-resistant Prostate Cancer, Abiraterone Acetate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • abiraterone acetateDrug

    Also called JNJ21208

    Abiraterone acetate is a selective and irreversible inhibitor of CYP17 which has demonstrated clinical efficacy in patients with CRPC. Currently, AA is administered with concomitant prednisone.

Study groups in NCT02025010
Study groupRoleWhat they receive
abiraterone acetateExperimentalParticipants will be treated with four 250 mg tablets (1,000 mg) of abiraterone acetate (AA) orally on 28-day cycles. For participants who experience persistent or severe mineralocorticoid excess or have PSA progression, prednisone 5 mg by mouth twice daily will be added. Patients will be treated until radiographic disease progression and unacceptable AE or taken off study for other reason.
Receives: Drug: abiraterone acetate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Toxicities That Required the Addition of Prednisone to Manage Symptoms of Persistent or Severe Mineralocorticoid Excess

    Patients requiring prednisone to manage toxicities such as COU-302 any grade or COU-301 grade 3-4 hypertension, hypokalemia and edema per CTCAE v. 4.0 were summarized using frequency and percentage.

    Measured: Patients were on abiraterone acetate up to 57 months and toxicities of mineralocorticoid excess were monitored each cycle (1cycle = 28 days).

Secondary outcomes (14)

  1. Safety and Tolerability Associated With AA Monotherapy and the Addition of Prednisone to AA.

    Grade 3 or higher toxicities attribution to AA monotherapy with or without prednisone were summarized descriptively.

    Measured: Adverse events were assessed continuously on treatment and up to 30 days after going off treatment (up to 55 months).

  2. Number of Participants Requiring the Addition of Prednisone to Manage Symptoms of Severe Fatigue.

    Participants initiated treatment with prednisone for ≥grade 3 fatigue were summarized using frequency and percentage.

    Measured: Patients were on abiraterone acetate up to 57 months.

  3. Changes in Serum Concentrations of Corticosteroid Intermediates Between the First and Second Assessment Visits.

    Percent change in corticosterone level between the first visit and the second visit was summarized by whether patients initiated prednisone for hypertension and hypokalemia.

    Measured: 1 month

  4. Changes in Serum Concentrations of ACTH Between Cycle 1 and Cycle 2.

    Changes in serum concentrations of ACTH at second assessment referent to the value at the first visit were summarized descriptively.

    Measured: 1 month

  5. Percent Changes in Serum Concentrations of Androgen (Including Testosterone, DHT and Androgen Precursors) Between Cycle 1 and Cycle 2.

    Change in corticosterone level between cycle 2 and cycle 1 was summarized by whether patients initiated prednisone for hypertension and hypokalemia.

    Measured: 1 month

  6. Changes in BMI Between Cycle 1 and Next Cycle

    Changes in BMI between cycle 1 and cycle 2 were summarized descriptively.

    Measured: 1 month

  7. Changes in Hemoglobin-A1c Between Cycle 1 and Next Cycle (Cycle 4)

    Changes in HbA1c at cycle 1 and next measurement at cycle 4 were summarized descriptively.

    Measured: 3 months

  8. PSA Response and Its Duration to AA Monotherapy.

    PSA response was defined per PCWG2 criteria (PSA reduction of ≥50%) and duration of PSA response is defined as time from PSA response to PSA progression or death, whichever occurs first.

    Measured: PSA was measured every cycle (up to 25 months)

  9. PSA Response and Its Duration to Addition of Prednisone to AA at Time of PSA Progression on AA Monotherapy.

    Among those who initiated prednisone due to PSA progression, duration of PSA response was calculated as time from PSA response (PSA reduction ≥50%) to PSA progression or death, whichever occurs first.

    Measured: PSA was measured every cycle (up to 25 months)

  10. Response of Measurable Disease to AA Monotherapy.

    Radiographic response of measurable disease is defined using RECIST v 1.1 for soft-tissue and visceral disease and PCWG2 for bone disease.

    Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm.

    Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

    Response is tabulated descriptively.

    Measured: Imaging was performed every 12 weeks up to 23 months.

  11. Number of Patients Who Received AA Monotherapy and Progressed With Measurable Disease at Pre-study

    Radiographic disease progression is defined using RECIST v 1.1 for soft-tissue and visceral disease and PCWG2 for bone disease (2 or more new lesions on bone scan and for the first 12-week assessment, defining disease progression requires a confirmatory scan performed 6 or more weeks later which shows a minimum of 2 additional new lesions).

    Measured: Imaging was performed every 12 weeks up to 23 months.

  12. Response of Measurable Disease to Addition of Prednisone to AA at Time of PSA Progression on AA Monotherapy.

    Radiographic response of measurable disease is defined using RECIST v 1.1 for soft-tissue and visceral disease and PCWG2 for bone disease.

    Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm.

    Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

    Response is tabulated descriptively.

    Measured: Imaging was performed every 12 weeks up to 23 months.

  13. Number of Patients Who Progressed With Measurable Disease at Pre-study Among Those Who Were Added of Prednisone to AA at Time of PSA Progression on AA Monotherapy.

    Radiographic response of measurable disease is defined using RECIST v 1.1 for soft-tissue and visceral disease and PCWG2 for bone disease. Due to small number patients, patients who experienced progressive disease were summarized using frequency and time to progression using Kaplan-Meier method was not calculated.

    Measured: Imaging was performed every 12 weeks up to 23 months.

  14. Subsequent Lines of Therapy

    Subsequent lines of therapy following study drug discontinuation were not collected for this trial.

    Measured: Data not collected.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Dec 2013 (estimated)
  2. Study start27 Jan 2014
  3. Primary completionDec 2021
  4. Study completion7 Apr 2025

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02025010
Sponsor's protocol ID
13-449
Status last verified
Apr 2025
First submitted
13 Dec 2013
Last updated
15 Apr 2025
Data monitoring committee
Yes

Publications

  • Sperger JM, Emamekhoo H, McKay RR, Stahlfeld CN, Singh A, Chen XE, Kwak L, Gilsdorf CS, Wolfe SK, Wei XX, Silver R, Zhang Z, Morris MJ, Bubley G, Feng FY, Scher HI, Rathkopf D, Dehm SM, Choueiri TK, Halabi S, Armstrong AJ, Wyatt AW, Taplin ME, Zhao SG, Lang JM. Prospective Evaluation of Clinical Outcomes Using a Multiplex Liquid Biopsy Targeting Diverse Resistance Mechanisms in Metastatic Prostate Cancer. J Clin Oncol. 2021 Sep 10;39(26):2926-2937. doi: 10.1200/JCO.21.00169. Epub 2021 Jul 1.

    PubMed 34197212

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing abiraterone acetate in people with Castration-resistant Prostate Cancer, run by Dana-Farber Cancer Institute at 8 sites 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 29 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 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Toxicities That Required the Addition of Prednisone to Manage Symptoms of Persistent or Severe Mineralocorticoid Excess (time frame: Patients were on abiraterone acetate up to 57 months and toxicities of mineralocorticoid excess were monitored each cycle (1cycle = 28 days).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02025010, which also lists 1 linked publication.

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 15 Apr 2025.

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