AzTrials
AzTrials

Prostate CancerPhase 2NCT02772588

AASUR in High Risk Prostate Cancer

A Phase 2 study testing ARN-509, Abiraterone and Leuprolide in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 11 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to determine whether anti-testosterone medications, when administered before, during, and after high-dose, precision radiation, will be effective in preventing the prostate cancer from returning. 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 and Leuprolide
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
11 sitesUnited States
Study dates
12 May 2016to 22 Jan 2026
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

  • Histological or cytologic evidence of adenocarcinoma of the prostate confirmed at local institution.
  • At least one of the following:
  • Two or more high risk features OR
  • Gleason score 8-10
  • PSA ≥20 ng/mL within two months prior to registration
  • Clinical Stage ≥T3 disease, as determined by standard digital rectal examination (DRE)
Show all 26Show fewer
  • Radiographic stage ≥T3 disease as determined by a ≥75% probability of extracapsular extension or seminal vesicle invasion per reading radiologist
  • Any Gleason 9 or 10 disease OR >4 cores of Gleason 8 disease
  • KPS ≥ 70%
  • IPSS (International Prostate Symptom Score) ≤ 20F
  • Patient must be available for follow-up
  • Laboratory test findings within 28 days of study registration :
  • Adequate hepatic function:
  • Bilirubin ≤ 1.5 times the upper institutional limits of normal (ULN). Patients with a history of Gilbert's syndrome may be enrolled if the total bilirubin is < 3 mg/dL with a predominance of indirect bilirubin. If the total bilirubin is >1.5 x the institutional ULN, direct and indirect bilirubin will be measured and if direct bilirubin is ≤ 1.5 x the institutional ULN, the patient will be eligible to participate
  • SGPT (ALT) and SGOT (AST) ≤ 2.5 x ULN
  • Adequate renal function with creatinine <2.0 x the institutional ULN
  • Adequate hematologic function:
  • Absolute neutrophil counts ≥ 1500 cell/mm3
  • Platelets ≥ 100,000 cells/mm3 (independent of blood transfusion and/or growth factors within 3 months prior to registration)
  • Hemoglobin value ≥9 g/dL at the Screening Visit (independent of blood transfusion and/or growth factors within 3 months prior to registration)
  • Albumin ≥ 3.0 g/dL
  • Potassium ≥ 3.5 mmol/L
  • Patients with pelvic and/or retroperitoneal lymph nodes < 1.5 cm in short axis are eligible as they are not considered to have definitive metastases
  • Willing and able to provide written informed consent and HIPAA authorization for the release of personal health information NOTE: HIPAA authorization may be either included in the informed consent or obtained separately
  • Males 18 years of age and above
  • The effects of apalutamide, abiraterone, leuprolide and stereotactic, ultra-hypofractionated radiation on the developing human fetus at the recommended therapeutic dose are unknown. Men (including men with vasectomies) must agree to use adequate contraception (a condom and another effective method of birth control) prior to registration, for the duration of study participation, and for at least 3 months thereafter. Men must also agree not to donate sperm for the duration of study participation, and for at least 3 months thereafter.

Who cannot join

  • Radiographic evidence of metastatic disease
  • Patients with one or more positive lymph nodes as determined by radiographic assessment of MRI or CT NOTE: lymph nodes noted on MRI or CT to be > 1.5 cm on the short axis will require review by the local reference radiologist per institutional RECIST review practices. If the lymph nodes are considered suspicious on repeat review, they must be confirmed negative for study participation
  • Prior treatment for prostate cancer; this includes any prior surgery (including Transurethral resection of the prostate (TURP), prostate cancer treatment), chemotherapy, radiation, or anti-androgen therapy/androgen deprivation therapy with the following exception: patients who will have been on LHRH Agonist/Antagonist Therapy for </= 1 month prior to registration are permitted to enroll with study PI approval.
  • Prior use of steroidal antiandrogens (megestrol acetate, cyproterone acetate), AR partial agonists, ketoconazole, chemotherapy, immunotherapy, estrogens, radiopharmaceuticals within 3 months before registration
  • Prior use of non-steroidal anti-androgens (e.g., bicalutamide, flutamide, nilutamide) within 1 month before registration
  • Prior treatment with medications known to lower the seizure threshold within 4 weeks of registration (see section 5.5.2 apalutamide for a list of prohibited medications)
Show all 28Show fewer
  • History of another malignancy within the previous 3 years except for the following: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, adequately treated Stage I or Stage II cancer currently in complete remission, or any other cancer that has been in complete remission for at least 3 years
  • Severe hepatic impairment (Child-Pugh Class C)
  • Concurrent treatment with strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital)
  • Major surgery within 4 weeks of registration
  • Presence of a pacemaker
  • Active infection or other medical condition that would make prednisone use contraindicated
  • A known hypersensitivity to abiraterone acetate, apalutamide, and prednisone and/or any of their excipients
  • 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 registration.
  • Seizure or known condition that may pre-dispose to seizure (including but not limited to prior stroke, transient ischemic attack, loss of consciousness within 1 year prior to randomization, brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect)
  • Any ECG changes that interfere with QT interval interpretation (e.g., left bundle branch block, frequent premature ventricular contractions)
  • Prolonged QTc >450ms at the Screening Visit
  • Uncontrolled diabetes, heart disease, hypertension
  • Gastrointestinal disorder that may affect absorption of study treatment
  • Active symptomatic viral hepatitis or chronic liver disease
  • History of pituitary or adrenal dysfunction
  • Active Infection (e.g., human immunodeficiency virus [HIV] or viral hepatitis) or other medical condition that would make prednisone/prednisolone corticosteroid) use contraindicated
  • Patients with Crohn's disease or ulcerative colitis
  • Patients that cannot tolerate MRI
  • Inability to have fiducial markers placed
  • Any condition that in the opinion of the investigator, would preclude participation in this study
  • Enrollment concurrently in another investigational drug study or within 4 weeks of registration
  • Concurrent treatment with strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital)

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109

  • John Hopkins Medical Center

    Baltimore, Maryland, 21287

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Weill Cornell Medical Center

    New York, New York, 10065

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Memorial Sloan Kettering Rockville

    Rockville Centre, New York

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553

Other trials in United States

About this study

Official title: ARN-509+Abiraterone Acetate+Leuprolide With Stereotactic, Ultra-Hypofractionated Radiation (AASUR) in Very High Risk Prostate Cancer: A Single Arm, Phase II Study

The purpose of this study is to determine whether anti-testosterone medications, when administered before, during, and after high-dose, precision radiation, will be effective in preventing the prostate cancer from returning.

Conditions
Prostate Cancer
Being tested
ARN-509, Abiraterone, Leuprolide, stereotactic, ultra-fractionated radiotherapy
Keywords
ARN-509, Abiraterone, Leuprolide, Intensity-Modulated and Image-Guided Radiation Therapy, 15-334, apalutamide,, JNJ-56021927
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • ARN-509Drug

    Also called apalutamide, JNJ-56021927

  • AbirateroneDrug

  • LeuprolideDrug

  • stereotactic, ultra-fractionated radiotherapyRadiation

Study groups in NCT02772588
Study groupRoleWhat they receive
patients with prostate cancerExperimentalEligible patients will receive a total of 6 months of leuprolide, abiraterone, and ARN-509 to begin three months prior to RT and continuing until approximately 3 months post-RT. Patients will be assessed every 4 weeks (±1 week) (a cycle = 28 days) throughout their treatment with the study drugs, and at least once during RT.
Receives: Drug: ARN-509; Drug: Abiraterone; Drug: Leuprolide; Radiation: stereotactic, ultra-fractionated radiotherapy

What is being measured

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

  1. Number of Participants With Biochemical Failure

    Biochemical failure is defined as an increase in PSA by more than 2ng/mL above the nadir value. PSA rise equals or exceeds 2ng/mL will be the date of failure.

    Measured: 36 months

Timeline

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

  1. First posted13 May 2016 (estimated)
  2. Study start12 May 2016
  3. Primary completion22 Jan 2026
  4. Study completion22 Jan 2026

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
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02772588
Sponsor's protocol ID
15-334
Other IDs
c15-164
Status last verified
Jan 2026
First submitted
12 May 2016
Last updated
13 Apr 2026

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ARN-509, Abiraterone and Leuprolide in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 11 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 26 inclusion and 28 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 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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 13 Apr 2026). 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 Biochemical Failure (time frame: 36 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 NCT02772588.

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 13 Apr 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