AASUR in High Risk Prostate Cancer

NCT02772588 | Completed Phase 2 Results

• 2 other identifiers: 15-334c15-164
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Prostate Cancer

Keywords

ARN-509; Abiraterone; Leuprolide; Intensity-Modulated and Image-Guided Radiation Therapy; 15-334; apalutamide,; JNJ-56021927

Outcome Measures

Primary Outcomes (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.

  36 months

Study Arms (1)

patients with prostate cancer

EXPERIMENTAL

Eligible 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.

Drug: ARN-509; Drug: Abiraterone; Drug: Leuprolide; Radiation: stereotactic, ultra-fractionated radiotherapy

Interventions

ARN-509 DRUG

Also known as: apalutamide, JNJ-56021927

patients with prostate cancer

Abiraterone DRUG

patients with prostate cancer

Leuprolide DRUG

patients with prostate cancer

stereotactic, ultra-fractionated radiotherapy RADIATION

patients with prostate cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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)
• 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)

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Janssen Pharmaceuticals: collaborator
• University of Michigan: collaborator
• Weill Medical College of Cornell University: collaborator

Study Sites (11)

John Hopkins Medical Center

Baltimore, Maryland, 21287, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Weill Cornell Medical Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Rockville

Rockville Centre, New York, United States

Location

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

apalutamide; abiraterone; Leuprolide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Dr. Sean McBride, MD
• Organization: Memorial Sloan Kettering Cancer Center

mcbrides@mskcc.org

646-608-2450

Study Officials

• Sean M McBride, MD, MPH

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2016
• First Posted: May 13, 2016
• Study Start: May 12, 2016
• Primary Completion: January 22, 2026
• Study Completion: January 22, 2026
• Last Updated: April 13, 2026
• Results First Posted: April 13, 2026

Record last verified: 2026-01

Locations

US (11)