Trial Search Results

A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer

The study will look at the efficacy of a new medication ARN-509 in men with prostate cancer who have a rising PSA but no evidence of prostate cancer in the bone. It will be compared to placebo in a blinded fashion.

ARN-509 is a novel androgen receptor (AR) antagonist for the treatment of castration-resistant prostate cancer (CRPC).

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Aragon Pharmaceuticals, Inc.

Stanford Investigator(s):

Intervention(s):

  • Drug: Apalutamide
  • Drug: Placebo

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Histologically or cytologically confirmed adenocarcinoma of the prostate without
   neuroendocrine differentiation or small cell features with high risk for development
   of metastases, defined as prostate-specific antigen doubling time (PSADT) less than or
   equal to (<=) 10 months. PSADT is calculated using at least 3 prostate-specific
   antigen (PSA) values obtained during continuous ADT (androgen deprivation therapy)

   - Castration-resistant prostate cancer demonstrated during continuous ADT, defined as 3
   PSA rises, at least 1 week apart, with the last PSA greater than (>) 2 nanogram per
   milliliter (ng/mL)

   - Maintain castrate levels of testosterone within 4 weeks prior to randomization and
   throughout the study

   - Patients currently receiving bone loss prevention treatment with bone-sparing agents
   must be on stable doses for at least 4 weeks prior to randomization

   - Patients who received a first generation anti-androgen (for example, bicalutamide,
   flutamide, nilutamide) must have at least a 4-week washout prior to randomization AND
   must show continuing disease (PSA) progression (an increase in PSA) after washout

   - At least 4 weeks must have elapsed from the use of 5-alpha reductase inhibitors,
   estrogens, and any other anti-cancer therapy prior to randomization

   - At least 4 weeks must have elapsed from major surgery or radiation therapy prior to
   randomization

   - Eastern Cooperative Oncology Group Performance Status 0 or 1

   - Resolution of all acute toxic effects of prior therapy or surgical procedure to Grade
   <= 1 or baseline prior to randomization

   - Adequate organ function according to protocol-defined criteria

   - Administration of growth factors or blood transfusions will not be allowed within 4
   weeks of the hematology labs required to confirm eligibility

Exclusion Criteria:

   - Presence of confirmed distant metastases, including central nervous system and
   vertebral or meningeal involvement

   - Symptomatic local or regional disease requiring medical intervention

   - Prior treatment with second generation anti-androgens

   - Prior treatment with CYP17 inhibitors

   - Prior treatment with radiopharmaceutical agents, or any other investigational agent
   for non-metastatic castration-resistant prostate cancer

   - Prior chemotherapy for prostate cancer except if administered in the
   adjuvant/neoadjuvant setting

   - History of seizure or condition that may pre-dispose to seizure

   - Concurrent therapy with protocol-defined excluded medications

   - History or evidence of any of the following conditions: any prior malignancy (other
   than adequately treated basal cell or squamous cell skin cancer, superficial bladder
   cancer, or any other cancer in situ currently in complete remission) within 5 years
   prior to randomization; severe/unstable angina, myocardial infarction, symptomatic
   congestive heart failure, arterial or venous thromboembolic events, or clinically
   significant ventricular arrhythmias within 6 months prior to randomization;
   uncontrolled hypertension; gastrointestinal disorder affecting absorption; active
   infection; and, any other condition that, in the opinion of the investigator, would
   impair the patient's ability to comply with study procedures

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Male

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting