Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

AASUR in High Risk Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02772588
Recruitment Status : Active, not recruiting
First Posted : May 13, 2016
Last Update Posted : February 9, 2022
Janssen Pharmaceuticals
Weill Medical College of Cornell University
University of Michigan
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: ARN-509 Drug: Abiraterone Drug: Leuprolide Radiation: stereotactic, ultra-fractionated radiotherapy Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2016
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: patients with prostate cancer
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
Other Names:
  • apalutamide
  • JNJ-56021927

Drug: Abiraterone
Drug: Leuprolide
Radiation: stereotactic, ultra-fractionated radiotherapy

Primary Outcome Measures :
  1. proportion of patients with biochemical failure [ Time Frame: 36 months ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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
  • 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.

Exclusion Criteria:

  • 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)
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02772588

Layout table for location information
United States, Maryland
John Hopkins Medical Center
Baltimore, Maryland, United States, 21287
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
United States, New Jersey
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States, 07645
United States, New York
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Weill Cornell Medical Center
New York, New York, United States, 10065
Memorial Sloan Kettering Rockville
Rockville Centre, New York, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, United States, 11553
United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Janssen Pharmaceuticals
Weill Medical College of Cornell University
University of Michigan
Layout table for investigator information
Principal Investigator: Sean M McBride, MD, MPH Memorial Sloan Kettering Cancer Center
Additional Information:
Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center Identifier: NCT02772588    
Other Study ID Numbers: 15-334
c15-164 ( Other Identifier: Prostate Cancer Clinical Trials Consortium, LLC (PCCTC) )
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: February 9, 2022
Last Verified: February 2022
Keywords provided by Memorial Sloan Kettering Cancer Center:
Intensity-Modulated and Image-Guided Radiation Therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents