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

Study Overview
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Brief Summary
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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.

Official Title
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An Open-Label, Single-Arm, Multiple Center Extension Study to Evaluate One Year of Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer With YONSA™ 500 mg (4 x 125 mg qd) With Methylprednisolone (4 mg Bid)

Conditions
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Metastatic Prostate Cancer

Intervention / Treatment
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* Drug: abiraterone acetate with Methylprednisolone


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YONSA with Methylprednisolone<br>Aberaterone Acetate 500 mg (4 x 125 mg qd) with Methylprednisolone (4 mg bid) | Drug: abiraterone acetate with Methylprednisolone<br>* YONSA 500 mg (4 x 125 mg qd) with Methylprednisolone (4 mg bid)<br>* Other names: YONSA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Adverse Events | Adverse events | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects With Disease Progression | Number of participants who had disease progression | one year | 
| Testosterone Levels | Change in serum testosterone levels from baseline | Baseline and 360 days | 
| Prostate Specific Antigen Levels | Change in serum testosterone levels after one year of treatment against baseline | One year | 
| Testosterone Complete Suppression | Proportion of subjects with complete suppression of testosterone levels | 360 days | 
| Percentage of Subjects With Prostate Specific Antigen - 50 Response | A decrease of ≥50% reduction from baseline of the study CHL-AA-201 | 360 days |