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Prostate CancerPhase 2PANTHERNCT03098836

Apalutamide and Abiraterone Acetate in African American and Caucasian Men With Metastatic Castrate Resistant Prostate Cancer

A Phase 2 study testing ARN-509, Abiraterone Acetate and Prednisone in people with Prostate Cancer, run by Daniel George, MD at 14 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

The primary goal is to prospectively estimate the median PFS of African American and Caucasian men with mCRPC taking apalutamide, abiraterone acetate, and prednisone. Secondary objectives include: PSA kinetics: to determine the duration of PSA response, time to nadir, and percent of men who achieve a PSA < 0.1… 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?
ARN-509, Abiraterone Acetate and Prednisone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
93 participants
Where
14 sitesUnited States
Study dates
10 Jul 2017to 9 Jul 2024
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

  • Male, age ≥ 18 years
  • Karnofsky performance status ≥ 70 (Appendix 1)
  • Life expectancy of ≥ 12 months as determined by treating investigator
  • Written Authorization for Use and Release of Health and Research Study Information (HIPAA authorization per institutional requirements)
  • Willing/able to adhere to the prohibitions and restrictions specified in this protocol
  • Willing to take abiraterone acetate on an empty stomach, and should be able to swallow tablets whole, without crushing/chewing tablets. Must have the ability to swallow, retain, and absorb oral medication.
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  • Medications known to lower the seizure threshold (see list under prohibited meds, appendix 2) must be discontinued or substituted at least 4 weeks prior to study entry
  • Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug. Must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug. Abstinence is an acceptable method of birth control.
  • Adequate bone marrow function as shown by: ANC ≥ 1.0 x 109/L, Platelets ≥ 100 x 109/L, Hb≥9 g/dL, (independent of transfusion and/or growth factors within 3 months prior to Cycle 1 Day 1)
  • Serum potassium ≥ 3.5 mEq/L
  • Serum albumin of ≥ 3.0 g/dl
  • AST/SGOT and ALT/SGPT <2.5 x Institutional Upper Limit of Normal (ULN)
  • Serum total bilirubin ≤ 1.5 x Institutional ULN (Note: In subjects with Gilbert's syndrome, if total bilirubin is >1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤1.5 × ULN, subject may be eligible)
  • GFR ≥45 mL/min
  • Histologically confirmed diagnosis of adenocarcinoma of the prostate. Histologic variants of prostate cancer comprising of >50% of the tumor including neuroendocrine features and small cell carcinoma of the prostate are excluded.
  • Radiographic evidence of metastatic disease based on RECIST 1.1 Criteria OR by prostate cancer-specific PET imaging. Evaluable non-target lesions and/or bone only metastasis are permitted per RECIST 1.1 and PCWG3 guidelines. Non-target, pathological lymph nodes ≥ 10 mm and less than 15 mm in the short axis are permitted.
  • Ongoing ADT using an LHRH agonist (e.g. leuprolide, goserelin) or antagonist (e.g. degarelix) must continue on therapy unless prior bilateral orchiectomy has been performed.
  • PSA ≥ 2.0 ng/mL
  • Evidence of castration resistant disease in the setting of ongoing ADT (medical or surgical) as evidenced by one of the following:
  • Absolute rise in PSA of 2.0 ng/mL or an increase >25% from the nadir, minimum 2 consecutive rising PSA levels with an interval of ≥ 1 week between each PSA level, OR
  • CT or MRI based evidence of disease progression (soft tissue, nodal or visceral disease progression) according to PCWG3 criteria or RECIST 1.1 criteria, OR
  • At least 1 new bone scan lesion as compared to the most immediate prior radiologic studies.
  • A minimum of 2 weeks elapsed off of antiandrogen therapy prior to start of study drug (i.e. flutamide, nilutamide, bicalutamide.)
  • A minimum of 2 weeks elapsed off of sipuleucel-T and radiation therapy prior to start of study drug
  • A minimum of 4 weeks from any major surgery prior to start of study drug.
  • Self-reported race of either African American or Caucasian.
  • Ability to understand and the willingness to sign a written informed consent document. If the subject is unable to understand the consent due to comorbidity, such as Alzheimer's disease, consent by a legally authorized representative and assent by the subject will be obtained.

Who cannot join

  • Prior treatment with abiraterone acetate, enzalutamide, apalutamide (ARN-509), galaterone (TOK-001), orteronel (TAK-700), or similar agent
  • Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
  • Active or symptomatic infection including HIV, viral hepatitis or chronic liver disease
  • Any chronic medical condition requiring a higher dose of corticosteroid than 5mg prednisone/prednisolone bid
  • Have known allergies, hypersensitivity, or intolerance to abiraterone acetate, apalutamide or prednisone or their excipients.
  • Pathological finding consistent with small cell carcinoma of the prostate
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  • Symptomatic liver or visceral organ metastasis
  • Have a history of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study agents
  • Known brain metastasis
  • Prior cytotoxic chemotherapy or biologic therapy for the treatment of CRPC. Note: sipulecel-T is permitted with a 2-week washout.
  • Previously treated with ketoconazole for prostate cancer for greater than 7 days
  • Prior systemic treatment with an azole anti-fungal drug (e.g. fluconazole, itraconazole) within 4 weeks of Cycle 1, Day 1.
  • Uncontrolled hypertension (systolic BP ≥ 140 mmHg or diastolic BP ≥ 90 mmHg). Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment
  • Poorly controlled diabetes, FBS ≥200 mg/dL
  • History of pituitary or adrenal dysfunction
  • Symptomatic Atrial Fibrillation, or other symptomatic cardiac arrhythmia
  • Other malignancy, except non-melanoma skin cancer, with a ≥ 30% probability of recurrence within 24 months
  • History of any of the following:
  • Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 6 months of Cycle 1 Day 1, brain arteriovenous malformation, Schwannoma, meningioma, or other benign CNS or meningeal disease which may require treatment with surgery or radiation therapy)
  • Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to first dose of study drug. Venous thrombolic events within 6 months are permitted IF they are not attributed to prostate cancer (in the opinion of the treating physician).
  • Avoid concomitant strong CYP3A4 inducers during abiraterone acetate treatment.
  • Avoid co-administration of abiraterone acetate with CYP2D6 substrates that have a narrow therapeutic index. If an alternative treatment cannot be used, exercise caution and consider a dose reduction of the concomitant CYP2D6 substrate
  • Baseline moderate or severe hepatic impairment (Child Pugh Class B \& C)
  • Use of herbal products that may decrease PSA levels (i.e., saw palmetto) refer to section 8.3.2 (no washout period required)
  • Administration of an investigational therapeutic within 30 days prior to Cycle 1, Day 1
  • Any condition which, in the opinion of the investigator, would preclude participation in this trial

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • Chesapeake Urology Associates

    Baltimore, Maryland, 21204

  • Duke Cancer Center Cary

    Cary, North Carolina, 27518

  • UNC Lineberger Cancer Center

    Chapel Hill, North Carolina, 27514

  • Johnston Hematology and Oncology of Clayton

    Clayton, North Carolina, 27520

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Virginia Oncology Associates

    Hampton, Virginia, 29303

  • Maria Parham Hospital

    Henderson, North Carolina, 27536

  • Scotland Memorial Hospital

    Laurinburg, North Carolina, 28352

  • Southeastern Regional

    Lumberton, North Carolina, 28358

  • Tulane University

    New Orleans, Louisiana, 70112

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Johnston Memorial Hospital

    Smithfield, North Carolina, 27577

  • Spartanburg Regional

    Spartanburg, South Carolina, 29303

Other trials in United States

About this study

Official title: Prospective Study of Apalutamide and Abiraterone Acetate iN ChemoTHerapy-Naïve mEn With mCRPC Stratified by Race

The primary goal is to prospectively estimate the median PFS of African American and Caucasian men with mCRPC taking apalutamide, abiraterone acetate, and prednisone. Secondary objectives include: PSA kinetics: to determine the duration of PSA response, time to nadir, and percent of men who achieve a PSA < 0.1; Radiographic assessments: to estimate the rate of objective response and incidence of bone flares; Safety (NCI CTC v4.0) and tolerability, particularly incidence and grade of hypertension in the two populations.

This is a non-comparative pilot open-label, parallel arm, multicenter study of apalutamide and abiraterone acetate in African American and Caucasian men with mCRPC. It is anticipated that 3 additional sites will be needed to accrue 100 subjects (50 African American and 50 Caucasian) over a 24 month accrual period. The study agents will be administerd at the following doses: apalutamide 240mg orally once daily, abiraterone acetate 1000mg orally once daily, and prednisone 5 mg BID in 4-week cycles throughout the treatment period.

Fifty (50) patients will be enrolled in each group (AA and Caucasians). The proportion of patients who experience PSA decline of 30%, 50% and 90% will be estimated with exact 95% confidence intervals based on the binomial distribution will be computed. In addition, post therapy changes in PSA will be explored as a continuous outcome. The Kaplan-Meier product limit method will be used to estimate the rPFS, biochemical PFS and overall survival distributions.

Conditions
Prostate Cancer
Being tested
ARN-509, Abiraterone Acetate, Prednisone
Keywords
metastatic, castrate resistant
Medical subject headings
Prostatic Neoplasms, Neoplasm Metastasis

What participants receive

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

  • ARN-509Drug

    Also called apalutamide

    240 mg orally daily

  • Abiraterone AcetateDrug

    Also called Zytiga

    1000 mg orally daily

  • PrednisoneDrug

    5 mg orally twice daily (for total daily dose 10 mg)

Study groups in NCT03098836
Study groupRoleWhat they receive
CaucasianExperimentalNot described
Receives: Drug: ARN-509; Drug: Abiraterone Acetate; Drug: Prednisone
African AmericanExperimentalNot described
Receives: Drug: ARN-509; Drug: Abiraterone Acetate; Drug: Prednisone

What is being measured

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

  1. Percentage of Participants With 2-Year Progression-Free Survival (PFS)

    Radiographic PFS based on PCWG2 criteria or based on the onset of a skeletal related event. Imaging obtained every 12 weeks. Kaplan-Meier estimate of percentage of participants is reported.

    Measured: every 12 weeks, up to 2 years

Secondary outcomes (7)

  1. 2-year PSA Progression Free Survival

    PSA progression-free survival

    Measured: every 4 weeks, up to 2 years

  2. Time to PSA Nadir

    Time to PSA nadir

    Measured: every 4 weeks, up to 2 years

  3. Percent of Men Who Achieve a PSA < 0.1

    Percent of men who achieve a PSA < 0.1

    Measured: every 4 weeks, up to 2 years

  4. Radiologic Response Rates

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions assessed by CT: Complete Response (CR), disappearance of all lesions and any pathologic lymph nodes (target or non-target) must have reduction in short axis to <10 mm; Partial Response (PR), ≥30% decrease in the sum diameter of target lesions as compared to the baseline sum diameter; Overall Response (OR) = CR + PR

    Measured: every 12 weeks, up to 2 years

  5. Percentage of Participants With Bone Flares

    Percentage of participants who experienced bone flares per radiographic assessments

    Measured: 12 weeks

  6. Percentage of Participants With Hypertension

    Safety (NCI CTC v4.0) and tolerability, particularly incidence and grade of hypertension in the two populations. Grade assessed according to NCI CTC v4.0 with higher grade being worse is reported.

    Measured: up to 2 years

  7. Median Overall Survival

    Survival of subjects over the time the study is ongoing

    Measured: every 6 months, up to 82 months

Timeline

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

  1. First posted4 Apr 2017
  2. Study start10 Jul 2017
  3. Primary completion9 Jul 2024
  4. Study completion9 Jul 2024

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03098836
Sponsor's protocol ID
Pro00075097
Acronym
PANTHER
Status last verified
Sep 2025
First submitted
28 Mar 2017
Last updated
12 Sep 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Piwarski SA, Howard LE, Paul MA, Bachelder N, LaCroix B, Clayton A, Allen D, Kephart J, Armstrong AJ, Patierno SR, George DJ, Hyslop T, Freedman JA. Genetic ancestry-concordant ceramide metabolism and response to androgen receptor pathway inhibition in metastatic castration-resistant prostate cancer. Cancer. 2026 Jun 1;132(11):e70371. doi: 10.1002/cncr.70371.

    PubMed 42186347

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ARN-509, Abiraterone Acetate and Prednisone in people with Prostate Cancer, run by Daniel George, MD at 14 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 27 inclusion and 26 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 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 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 12 Sep 2025). 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?

Percentage of Participants With 2-Year Progression-Free Survival (PFS) (time frame: every 12 weeks, up to 2 years). 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 NCT03098836, 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 12 Sep 2025.

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