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The Role of Highly Selective Androgen Receptor (AR) Targeted Therapy in Men With Biochemically Relapsed Hormone Sensitive Prostate Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

The Role of Highly Selective Androgen Receptor (AR) Targeted Therapy in Men With Biochemically Relapsed Hormone Sensitive Prostate Cancer


Key

Inclusion Criteria:



- Histologically proven adenocarcinoma of the prostate

- 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 by CT/MRI abdomen/pelvis and whole body bone scan

- 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

- No androgen deprivation therapy or anti-androgen (i.e. bicalutamide) within 12 months
of study entry

- 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

Key Exclusion Criteria:

- Use of 5-alpha reductase antagonist (i.e. finasteride, dutasteride) within 3 months
of study entry

- Use of antiandrogen (e.g. flutamide, nilutamide, bicalutamide) within 12 months of
study entry

- Prior bilateral orchiectomy

- Prior hormonal treatment with ADT or antiandrogen for biochemically relapsed prostate
cancer

- Use of systemic steroids at an equivalent dose of prednisone 5 mg/day or higher at
the time of study entry

- Any history of seizures or medical condition which lowers seizure threshold

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Mean change in quality of life (QOL) measured by total FACT-P score

Outcome Description:

To compare the mean change in QOL as measured by total FACT-P score after 12 months of therapy with ARN-509 monotherapy and ARN-509 + LHRHa versus LHRHa monotherapy, in men with biochemically relapsed prostate cancer.

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Edna Chow Maneval, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Aragon Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

ARN-509-002

NCT ID:

NCT01790126

Start Date:

February 2013

Completion Date:

February 2018

Related Keywords:

  • Prostate Cancer
  • Men with Biochemically Relapsed Hormone Sensitive Prostate Cancer
  • Prostatic Neoplasms

Name

Location

Oregon Health & Science UniversityPortland, Oregon  97201
University of Chicago Comprehensive Cancer CenterChicago, Illinois  60637-1470
Mayo Clinic ArizonaScottsdale, Arizona  85259
Seattle Cancer Care Alliance/University of WashingtonSeattle, Washington  98109
University of California San Francisco (UCSF) Medical CenterSan Francisco, California  94115