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Metastatic Prostate CarcinomaPhase 2NCT03821792

Abiraterone Acetate, Prednisone, and Apalutamide in Treating Patients With Hormone-Naive Metastatic Prostate Cancer

A Phase 2 study testing Abiraterone Acetate, Apalutamide and Prednisone in people with Metastatic Prostate Carcinoma and Prostate Adenocarcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This phase II trial studies how well abiraterone acetate, prednisone, and apalutamide work in treating patients with hormone-naive prostate cancer that has spread to other places in the body. Androgen can cause the growth of prostate cancer cells. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Abiraterone Acetate, Apalutamide and Prednisone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
22 Jul 2019to 11 Oct 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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
  • At least 2 of the 3 following high-risk prognostic factors:
  • Gleason score of >= 8
  • Presence of 3 or more lesions on bone scan
  • Presence of measurable visceral (excluding lymph node disease) metastasis on computed tomography (CT) or magnetic resonance imaging (MRI) (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)
  • Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
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  • Hemoglobin >= 9.0 g/dL independent of transfusion and/or growth factors within 3 months prior to enrollment
  • Platelet count >= 100,000/uL independent of transfusion and/or growth factors within 3 months prior to enrollment
  • Serum albumin >= 3.0 g/dL
  • Medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks prior to study entry
  • Absolute neutrophil count (ANC) >= 1,500/mm^3
  • Calculated creatinine clearance (Cockcroft-Gault equation) >= 45 mL/min
  • Serum potassium >= 3.5 mEg/L
  • Serum magnesium >= 1.6 mg/dL
  • Serum bilirubin < 1.5 x institutional upper limit of normal (IULN) (except for patients with known Gilbert's disease if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject may be eligible)
  • Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2.5 x IULN for patients without liver metastases. (Note: In subjects with Gilbert's syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject may be eligible. For patients with liver metastases AST or ALT < 4 x IULN is allowed)
  • Able to swallow study drugs whole as a tablet/capsule
  • 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
  • Patients must agree to tissue collection for correlative studies at the specified time points

Who cannot join

  • Small cell prostate cancer
  • Treatment within 28 days of cycle 1 day 1: Any prior pharmacotherapy, radiation therapy, or surgery for metastatic prostate cancer. The following exceptions are permitted:
  • Up to 3 months of antiandrogen therapy (ADT) with LHRH agonists or antagonists or orchiectomy with or without concurrent anti-androgens prior to cycle 1 day 1. Anti-androgens (flutamide, bicalutamide or nilutamide) for subjects receiving an LHRH agonist must be discontinued within 2 weeks of cycle 1 day 1, or subjects may have one course of palliative radiation or surgical therapy to treat symptoms resulting from metastatic disease (e.g., impending cord compression or obstructive symptoms) if it was administered at least 28 days prior to cycle 1 day 1. All adverse events associated with these procedures must be resolved at least to grade 1 by cycle 1 day 1, or
  • Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone/prednisolone daily. Use of inhaled, intranasal, intra-articular and topical steroids are acceptable, as is a short course (i.e. =< 1 day) of corticosteroids to prevent a reaction to the intravenous (IV) contrast used for CT scans
  • Active infection (requiring oral or IV antibiotics or antiviral therapy) or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
  • A malignancy (other than the one treated in this study) which required radiotherapy or systemic treatment within the past 5 years, or has a >= 30% probability of recurrence within 24 months (except for non-melanoma skin cancer or Ta urothelial carcinomas)
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  • Chronically uncontrolled hypertension, defined conventionally as consistent systolic pressures above 170 or diastolic pressures above 110 despite anti-hypertensive therapy. Note that this is NOT a criterion related to particular blood pressure (BP) results at the time of assessment for eligibility, nor does it apply to acute BP excursions that are related to iatrogenic causes, acute pain or other transient, reversible causes. (For example doctor's visit related stress i.e. "white coat syndrome")
  • Prolonged corrected QT interval by Fridericia's formula (QTcF) interval on pre-entry electrocardiogram (>= 450 msec)
  • Known active or symptomatic viral hepatitis or chronic liver disease
  • Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsade de pointes), New York Heart Association class III-IV heart disease or cardiac ejection fraction measurement of < 40% at baseline
  • Patients who have had a history of illness which put them at current risk for bowel perforation such as acute diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction and abdominal carcinomatosis
  • Baseline moderate and severe hepatic impairment (Child Pugh class B \& C)
  • Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign central nervous system [CNS] or meningeal disease which may require treatment with surgery or radiation therapy)
  • Gastrointestinal disorder affecting absorption
  • Untreated symptomatic spinal cord compression
  • Any underlying medical or psychiatric condition, which in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Phase 2 Course Determining Study for Men With Hormone-Naïve Metastatic Prostate Cancer (HNMPCa)

This phase II trial studies how well abiraterone acetate, prednisone, and apalutamide work in treating patients with hormone-naive prostate cancer that has spread to other places in the body. Androgen can cause the growth of prostate cancer cells. Antihormone therapy, such as abiraterone acetate and apalutamide may lessen the amount of androgen made by the body.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine if a baseline molecular-pathologic androgen receptor response (AR-response) signature predicts efficacy to abiraterone plus apalutamide in patients with hormone-naive metastatic prostate cancer (HNMPCa).

SECONDARY OBJECTIVES:

  1. Evaluate the efficacy of abiraterone acetate plus apalutamide in patients with HNMPCa.

II. Evaluate the safety of abiraterone acetate plus apalutamide in patients with HNMPCa.

III. Explore the relationship between molecular markers and clinical efficacy outcomes.

OUTLINE:

Patient receive abiraterone acetate orally (PO) daily, prednisone PO twice daily (BID), and apalutamide PO daily. Cycles repeat every 28 days for 1 year in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and then for up to 6 months.

Being tested
Abiraterone Acetate, Apalutamide, Prednisone
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • Abiraterone AcetateDrug

    Also called CB7630, Yonsa, Zytiga

    Given PO

  • ApalutamideDrug

    Also called ARN 509, ARN-509, ARN509, Erleada

    Given PO

  • PrednisoneDrug

    Also called .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl

    Given PO

Study groups in NCT03821792
Study groupRoleWhat they receive
Treatment (abiraterone acetate, prednisone, apalutamide)ExperimentalPatient receive abiraterone acetate PO daily, prednisone PO BID, and apalutamide PO daily. Cycles repeat every 28 days for 1 year in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Abiraterone Acetate; Drug: Apalutamide; Drug: Prednisone

What is being measured

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

  1. Time on treatment

    Calculated as the time from start of protocol treatment

    Measured: Up to 6 months

Secondary outcomes (5)

  1. Progression free survival (PFS)

    Median PFS and 95% confidence interval will be presented for all patients and by the androgen receptor molecular-pathologic responsiveness signature.

    Measured: Time from starting treatment until progression, assessed up to 6 months

  2. Incidence of adverse events

    Will be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.

    Measured: Up to 6 months

  3. Efficacy assessed

    prostate specific antigen, bone specific alkaline phosphatase, and urine n-telopeptides

    Measured: Up to 6 months

  4. Expression of candidate markers

    Candidate markers for different biologic domains by immunohistochemistry, mass spectrometry (for steroid metabolome) and genomic profiling. Markers will encompass bone remodeling (e.g. integrin signaling), steroid metabolome (e.g. glucocorticoid receptor) and tumor immunoprofile (e.g. PD-1, PDL-1).

    Measured: Up to 6 months

  5. Overall survival

    Time from start of protocol treatment until death or last contact

    Measured: up to 6 months

Timeline

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

  1. First posted30 Jan 2019
  2. Study start22 Jul 2019
  3. Primary completion11 Oct 2028 (estimated)
  4. Study completion11 Oct 2028 (estimated)

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 (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03821792
Sponsor's protocol ID
2018-0533
Other IDs
NCI-2018-03599, 2018-0533
Status last verified
Oct 2026
First submitted
25 Jan 2019
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abiraterone Acetate, Apalutamide and Prednisone in people with Metastatic Prostate Carcinoma and Prostate Adenocarcinoma, run by M.D. Anderson Cancer Center 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 19 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2026. 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.

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?

This study is still under way. Results are not available in the source record yet.

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?

Time on treatment (time frame: Up to 6 months). 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 NCT03821792.

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 7 Oct 2026.

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