West Cancer Center

PROSTATE: Metastatic; 2nd line; "AFFINITY"

A randomized phase 3 study comparing cabazitaxel/prednisone in combination with custirsen (OGX-011) to cabazitaxel/prednisone for second-line chemotherapy in men with metastatic castrate resistant prostate cancer (AFFINITY)

Title

Onco-Genex 011-12

Study Title

Site Link

NCT01578655

Malignancy

Prostate, CRPC, Castration Resistant

Stage

Stage 4

Disease Setting

_Metastatic/palliative, castration resistant

Line Of Therapy

_2nd line (post docetaxel)

Investigational Agent

Custirsen

Drug Class

Inhibitor of clusterin expression

Brad Somer, MD

Sponsor

Oncogenex Technologies

Phase

Phase 3

Status

Closed to Accrual

Key Eligibility Criteria

Key Eligibility Criteria Details

_Radiographic evidence of metastatic disease (CT or bone scan), previous 1st line docetaxel containing regimen, radiographic progression on 1st line OR PSA increasing from starting value of at least 5, needs to continue primary ADT, no planned changes in bone directed therapy, no prior radioisotope, no CNS disease, no tx with CYP3A inhibitors or inducers.

Objective

Primary: Overall survival. Secondary: Progression-free survival at Day 140

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

_Adenocarcinoma

Dosing Frequency

...

Control Agents

Cabazitaxel and predisone

Study Protocol

Randomized

Yes