West Cancer Center

PROSTATE: Non-metastatic; high-risk; anti-androgen; "SPARTAN"

A multicenter, randomized, double-blind, placebo-controlled, phase III study of ARN-509 in men with non-metastatic (M0) castration-resistant prostate cancer

Title

Aragon ARN-509-003

Study Title

A multicenter, randomized, double-blind, placebo-controlled, phase III study of ARN-509 in men with non-metastatic (M0) castration-resistant prostate cancer

Site Link

NCT01946204

Malignancy

Prostate cancer, non-metastatic, castrate resistant prostate, CRPC, PSA recurrent

Stage

Stage 4

Disease Setting

Non-metastatic, PSA recurrence

Line Of Therapy

After failure of ADT

Investigational Agent

ARN-509

Drug Class

Anti-androgen

Brad Somer, MD

Sponsor

Aragon Pharmaceuticals

Phase

Phase 3

Status

Closed to Accrual

Key Eligibility Criteria

http://www.clinicaltrials.gov/ct2/show/NCT01946204

Key Eligibility Criteria Details

Adenocarcinoma without neuroendocrine or small cell features
PSADT of < /=10 months (3 rising values during ADT, last >2ng/ml)
No evidence of metastasis (pelvic nodes up to 2cm allowed)
Castrate levels of testosterone x 4 weeks prior
Stable doses of bone resorptive agents x4 weeks prior
No anti-androgen x 4 weeks prior (ie. bicalutamide)
No surgery x 4 weeks prior
ECOG PS 0-1
No prior tx with 2nd gen anti-androgens
No hx of seizures
No prior malignancy (except skin and superficial bladder) within 5 years
No cardiac disease within 5years

Objective

Primary- Metastasis free survival: Secondary- OS, time to symptomatic progression, time to start of chemo, PFS

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Adenocarcinoma. No neuroendocrine differentiation or small cell features.PSA doubling time of <10 months

Dosing Frequency

ARN 509 240mg PO qday

Control Agents

placebo PO qday

Study Protocol

Randomized

Yes