The Role of Highly Selective Androgen Receptor (AR) Targeted Therapy in Men With Biochemically Relapsed Hormone Sensitive Prostate Cancer
NCT ID: NCT01790126
Last Updated: 2020-03-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
90 participants
INTERVENTIONAL
2013-03-04
2019-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ARN-509
ARN-509 Tablets, 240 mg/day administered orally
ARN-509
LHRH agonist + ARN-509
Choice of LHRHa per investigator discretion/site practice guidelines (e.g, Eligard®, Zoladex®, Lupron Depot®, Trelstar®) and ARN-509 Tablets, 240 mg/day administered orally
ARN-509
LHRH Agonist
LHRH agonist
Choice of LHRHa per investigator discretion/site practice guidelines (e.g., Eligard®, Zoladex®, Lupron Depot®, Trelstar®).
LHRH Agonist
Interventions
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ARN-509
LHRH Agonist
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Rising PSA after prior definitive local therapy (radical prostatectomy, external beam radiation, or brachytherapy) or combination of radical prostatectomy and radiotherapy with curative intent
* PSA doubling time less than or equal to 12 months
* No evidence of metastatic disease on imaging by whole body bone scan and computerized tomography (CT) or Magnetic Resonance Imaging (MRI) of the abdomen/pelvis within 6 weeks prior to randomization
* Minimum PSA 1.0 ng/mL if prior radical prostatectomy +/- adjuvant or salvage radiation; nadir + 2.0 ng/mL if prior RT without prior radical prostatectomy
* Prior androgen deprivation therapy (ADT) allowed if last dose was greater than (\>) 6 months prior to randomization
* No prior androgen deprivation therapy (ADT) or anti-androgen for biochemical relapse
* Serum testosterone \> 150 ng/dL at study entry
* No history of seizures or medical conditions which may lower seizure threshold
Exclusion Criteria
* Use of antiandrogen (e.g. flutamide, nilutamide, bicalutamide) within 6 weeks prior to randomization
* Prior bilateral orchiectomy
* Prior treatment with ADT for biochemically relapsed prostate cancer. Prior ADT as neo-adjuvant, concurrent, and/or adjuvant treatment following salvage radiation therapy or prostatectomy for biochemically relapsed disease is allowed provided last dose of ADT is greater than (\>) 6 months prior to randomization and the Screening serum testosterone level is greater than or equal to (≥)150 ng/dL
* Use of systemic steroids at an equivalent dose of prednisone 5 mg/day or higher at randomization
* Any history of seizures or medical condition which lowers seizure threshold
18 Years
MALE
No
Sponsors
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Aragon Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Aragon Pharmaceuticals, Inc Clinical Trial
Role: STUDY_DIRECTOR
Aragon Pharmaceuticals, Inc.
Locations
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Scottsdale, Arizona, United States
San Francisco, California, United States
Chicago, Illinois, United States
Portland, Oregon, United States
Seattle, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ARN-509-002
Identifier Type: -
Identifier Source: secondary_id
CR103305
Identifier Type: -
Identifier Source: org_study_id
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