AzTrials
AzTrials

Castration-Resistant Prostate CarcinomaPhase 2NCT03360721

Apalutamide, Abiraterone Acetate, and Prednisone in Treating Participants With Metastatic Castration Resistant Prostate Cancer

A Phase 2 study testing Abiraterone Acetate, Apalutamide and Prednisone in people with Castration-Resistant Prostate Carcinoma and Prostate Adenocarcinoma Without Neuroendocrine Differentiation, run by M.D. Anderson Cancer Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This phase II trial studies how well apalutamide and abiraterone acetate work in treating participants with castration resistant prostate cancer that has spread to other places in the body (metastatic). 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
7 participants
Where
1 siteUnited States
Study dates
6 Mar 2018to 12 Mar 2026
Phase
Phase 2
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 without neuroendocrine differentiation or small cell features
  • Presence of metastatic disease that can be biopsied by any methodology applicable
  • Ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or orchiectomy (i.e., surgical or medical castration)
  • Serum testosterone level =< 50 ng/dL at the screening visit
  • Progressive disease defined as one or more of the following three criteria (NOTE: Patients who received an antiandrogen must demonstrate disease progression following discontinuation of antiandrogen):
  • PSA progression defined by a minimum of two rising PSA levels with an interval of >= 1 weeks between each determination. The PSA value at the screening visit should be >= 2 ng/mL
Show all 21Show fewer
  • Soft tissue disease progression as defined by the Response Evaluation Criteria in Solid Tumors (RECIST)
  • Bone disease progression defined by two or more new lesions on bone scan
  • Patients previously treated with chemotherapy must have no more than two prior chemotherapy regimens for the treatment of metastatic prostate cancer
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Serum albumin >= 3.0 g/dL
  • Serum potassium >= 3.5 mmol/L
  • Estimated life expectancy of >= 6 months
  • Able to swallow the study drug and comply with study requirements
  • Willing and able to give informed consent
  • Tumor specimen obtained prior to treatment initiation by interventional radiology guided biopsy will be interrogated per immunohistochemistry (IHC) and features should be as follows for a patient to be eligible
  • Overexpression of androgen receptor (AR)-C terminal and AR-N terminal and PTEN with lack of ARV7 expression along with and ki67 =<10%
  • No combined RB loss and p53 mutation and
  • No expression of neuroendocrine markers CD56 and chromogranin (all markers assessed by standardized IHC protocols)
  • 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
  • The methods must consist of a condom and the use of another barrier method (such as a diaphragm or cervical/vault caps) with a spermicidal agent. Your female partner can choose to use an intrauterine device or system (intrauterine device [IUD] or intrauterine system [IUS]) or use birth control pills, injections, or implants instead of a barrier method

Who cannot join

  • Known allergy to the study drugs or any of its components
  • Severe, concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollment or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
  • Known metastases to the brain
  • Absolute neutrophil count < 1000/uL at the screening visit
  • Platelet count =< 100,000 x 10^9/uL at the screening visit
  • Hemoglobin < 9 g/dL at the screening visit at the screening visit
Show all 46Show fewer
  • NOTE: patients may not have received any growth factors or blood transfusions within seven days of the hematologic laboratory values obtained at the screening visit
  • Total bilirubin (Tbili) > 1.5 times the upper limit of normal at the screening visit
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 times the upper limit of normal at the screening visit
  • Creatinine (Cr) > 2 mg/dL at the screening visit
  • History of another malignancy within the previous 2 years with > 30 % probability of relapse other than curatively treated non-melanomatous skin cancer
  • Treatment with androgen receptor antagonists (bicalutamide, flutamide, nilutamide), 5-alpha reductase inhibitors (finasteride, dutasteride), estrogens, chemotherapy, or biologic therapy within 4 weeks of enrollment (day 1 visit)
  • Radiation therapy within 3 weeks (if single fraction of radiotherapy within 2 weeks) of enrollment (day 1 visit)
  • Planned palliative procedures for alleviation of bone pain such as radiation therapy or surgery
  • Structurally unstable bone lesions suggesting impending fracture
  • History of seizure or any condition that may increase the patient's seizure risk. Also, history of loss of consciousness or transient ischemic attack within 12 months of day 1
  • Clinically significant cardiovascular disease including:
  • Myocardial infarction within 6 months
  • Uncontrolled angina within 6 months
  • Congestive heart failure New York Heart Association (NYHA) class 3 or 4 in the past, or history of anthracycline or anthracenedione (mitoxantrone) treatment, unless a screening echocardiogram or multi-gated acquisition scan (MUGA) performed within three months results in a left ventricular ejection fraction that is >= 45%
  • History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes)
  • Prolonged corrected QT interval by the Fridericia correction formula (QTcF) on the screening electrocardiogram (ECG) > 470 msec
  • History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place
  • Hypotension (systolic blood pressure < 86 millimeters of mercury or bradycardia with a heart rate of < 50 beats per minute on any ECG taken at the screening visit
  • Bradycardia with a heat rate of < 50 beats per minutes in the screening ECG, unless pharmaceutically induced and reversible
  • Chronically uncontrolled hypertension as indicated by consistently elevated resting blood pressure (systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg) during screening
  • Have used or plan to use from 30 days prior to enrollment (day 1 visit) through the end of the study the following medications known to lower the seizure threshold:
  • Aminophylline/theophylline
  • Atypical antipsychotics (e.g., clozapine, olanzapine, risperidone, ziprasidone)
  • Bupropion
  • Insulin
  • Lithium
  • Pethidine
  • Phenothiazine antipsychotics (e.g., prochlorperazine [compazine], chlorpromazine, mesoridazine, thioridazine)
  • Tricyclic and tetracyclic antidepressants (e.g., amitriptyline, desipramine, doxepin, imipramine, maprotiline, mirtazapine)
  • Prior use of ketoconazloe, enzalutamide, abiraterone or apalutamide or participation in a previous clinical trial of ketoconazloe,enzalutamide, abiraterone or apalutamide unless within the neoadjuvant setting
  • Use of an investigational agent within 4 weeks of enrollment (day 1)
  • Gastrointestinal disorder affecting absorption (e.g., gastrectomy)
  • Major surgery within 4 weeks prior to enrollment (day 1)
  • History of significant bleeding disorder unrelated to cancer, including:
  • Diagnosed congenital bleeding disorders (e.g., von Willebrand's' disease)
  • Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies)
  • History of gastrointestinal (GI) bleeding within one year
  • Known active or symptomatic viral hepatitis or chronic liver disease
  • Known history of pituitary or adrenal dysfunction
  • Baseline moderate and severe hepatic impairment (Child Pugh class B \& C)

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, Study of Apalutamide and Abiraterone Acetate in Castration-Resistant Metastatic Prostate Cancer Patients Evaluating a Predetermined Biomarker Signature

This phase II trial studies how well apalutamide and abiraterone acetate work in treating participants with castration resistant prostate cancer that has spread to other places in the body (metastatic). Abiraterone acetate and apalutamide may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunosuppressive therapy, such as prednisone, is used to decrease the body's immune response and may improve bone marrow function. Giving apalutamide, abiraterone acetate, and prednisone may work better in treating participants with castration resistant prostate cancer.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To assess the radiographic progression free survival (PFS) of men with metastatic castration resistant prostate cancer (mCRPC) who are selected for treatment based on positive biomarker signature.

SECONDARY OBJECTIVES:

  1. Safety. II. Composite progression free survival (PFSc) defined by Prostate Cancer Working Group 2 (PCWG2) (radiographic progression, prostate specific antigen [PSA] progression, or clinical deterioration).

III. Overall survival. IV. Exploratory biomarker analyses. V. Measures of prostate specific antigen (PSA) decline and associations with outcome.

VI. Radiologic response by PCWG2 criteria. VII. Measures of circulating tumor cell (CTC) and conversion to undetectable and/or favorable < 5.

OUTLINE:

Participants receive abiraterone acetate orally (PO) once daily (QD), apalutamide PO QD, and prednisone PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, participants are followed up for up to 16 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 NCT03360721
Study groupRoleWhat they receive
Treatment (abiraterone acetate, apalutamide, prednisone)ExperimentalParticipants receive abiraterone acetate PO once daily QD, apalutamide PO QD, and prednisone PO QD on days 1-28. Cycles repeat every 28 days 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. Progression free survival (PFS)

    Will be assessed using primary analysis set (PAS). Kaplan-Meier curves will be presented.

    Measured: From enrollment until radiographic progression, death from any cause, start of other therapy or last follow-up without progression, whichever comes first assessed up to 28 months

Secondary outcomes (6)

  1. Incidence of adverse events

    Will be assessed according to Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.03 with grade and attribution to study drug.

    Measured: Up to 28 months

  2. Composite progression free survival (PFSc)

    Will be assessed using PAS.

    Measured: From protocol treatment start until Prostate Cancer Working Group 2 (PCWG2) progression (radiographic progression, PSA progression, or clinical deterioration), death, starting new treatment or last follow-up without PCWG2 progression

  3. Overall survival (OS)

    Will be assessed using PAS.

    Measured: Baseline until death or last contact, assessed up to 28 months

  4. Androgen expression signaling

    Will be assessed using marker evaluable set (MES). The association between the biomarker and PSA level will be estimated using Spearman's rank correlation.

    Measured: Baseline to week 13

  5. Survival escape pathway signaling

    Will be assessed using MES.

    Measured: Baseline to week 13

  6. PSA measurement

    Measured: Up to 28 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 Dec 2017
  2. Study start6 Mar 2018
  3. Primary completion12 Mar 2026
  4. Study completion12 Mar 2026

Why it stopped: \<75% participation

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
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03360721
Sponsor's protocol ID
2017-0060
Other IDs
NCI-2018-01054, 2017-0060
Status last verified
Mar 2026
First submitted
28 Nov 2017
Last updated
16 Mar 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 Castration-Resistant Prostate Carcinoma and Prostate Adenocarcinoma Without Neuroendocrine Differentiation, 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 21 inclusion and 46 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: stopped early, as of the sponsor's last update on 16 Mar 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?

The study was stopped early (reason given: \<75% participation). Results are not available in the source record.

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?

Progression free survival (PFS) (time frame: From enrollment until radiographic progression, death from any cause, start of other therapy or last follow-up without progression, whichever comes first assessed up to 28 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 NCT03360721.

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 16 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in