One-year, Open Extension to Evaluate the Treatment of Patients With Castration-Resistant Prostate Cancer With YONSA™

Sun Pharmaceutical Industries Limited20 enrolled

Overview

This is an open-label, single-arm, multi-center extension study to evaluate safety in patients with mCRPC of YONSA 500 mg (4 x 125 mg qd) with methylprednisolone (4 mg bid). Patients will have successfully completed an 84-day treatment with abiraterone acetate in a previous trial. Results from the final visit of the previous study will be used to determine patient's eligibility for this study. Patients in this study will be eligible to receive open-label YONSA with methylprednisolone for up to 12 months. Pharmacodynamic parameters of serum testosterone and PSA levels will be monitored. Disease progression will be assessed by PCWG2 criteria.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastatic Prostate Cancer

Interventions

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Successful completion of 84 days of treatment with YONSA in Churchill Pharmaceuticals clinical trial, CHL-AA-201 * Last dose of YONSA or Zytiga within 45 days prior to treatment in this study * Written informed consent obtained prior to any study-related procedure being performed * Has in the investigator's opinion, the potential to gain clinical benefit with YONSA treatment * Ongoing therapy with a GnRH agonist or antagonist AND serum testosterone level \<50 ng/dL at screening * Life expectancy of at least 9 months at screening * Subject is willing and able to comply with all protocol requirements assessments * Agrees to protocol-defined use of effective contraception. Exclusion Criteria: * Serious concurrent illness, including psychiatric illness, that would interfere with study participation * Inability to swallow tablets whole * Known hypersensitivity to YONSA, methylprednisolone, or any excipients in study medications * Moderate to severe hepatic impairment (Child-Pugh Classes B and C)

Outcomes

Primary Outcomes

Number of Subjects With Adverse Events

Adverse events

Time frame: one year

Secondary Outcomes

Proportion of Subjects With Disease Progression

Number of participants who had disease progression

Time frame: one year

Testosterone Levels

Change in serum testosterone levels from baseline

Time frame: Baseline and 360 days

Prostate Specific Antigen Levels

Change in serum testosterone levels after one year of treatment against baseline

Time frame: One year

Testosterone Complete Suppression

Proportion of subjects with complete suppression of testosterone levels

Time frame: 360 days

Percentage of Subjects With Prostate Specific Antigen - 50 Response

A decrease of ≥50% reduction from baseline of the study CHL-AA-201

Time frame: 360 days