Conditions

Metastatic Castration-resistant Prostate Cancer

Purpose of the study

Substudy 01A is part of a larger research study that is testing experimental treatments for metastatic castration-resistant prostate cancer (mCRPC). The larger study is the umbrella study (U01). 

The goal of substudy 01A is to evaluate the safety and efficacy of opevesostat-based treatment combinations, or as a single agent, in participants with mCRPC.  NCT06353386

Official Title

MK-5684-01A Substudy: A Phase 1/2 Umbrella Substudy of MK-5684-U01 Master Protocol to Evaluate the Safety and Efficacy of MK-5684-Based Treatment Combinations or MK-5684 Alone in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC).

Who is eligible to participate?

• Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate without small cell histology. 

• Prostate cancer progression and received androgen deprivation therapy (ADT) or post bilateral orchiectomy within 6 months before screening. 

• Evidence of disease progression from either, >4 weeks from last flutamide treatment, or >6 weeks from last bicalutamide or nilutamide treatment, if receiving first generation anti-androgen therapy as last treatment therapy. 

• Current evidence of metastatic disease. 

• Prior treatment with 1 to 2 novel hormonal agent(s) (NHA) for non-metastatic, or metastatic, hormone-sensitive prostate cancer or castration-resistant prostate cancer and have disease progression during or after treatment. 

• Treatment with bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses for >4 weeks before randomization. 

• Participants who experienced adverse events (AEs) due to previous anticancer therapies must have recovered to <Grade 1 or baseline. 

• Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy. 

• Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load. 

• Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable. 

Register your interest

To register your interest or find out more information about this clinical trial, please email: enquiries@gallipoliresearch.org.au. 

Study location

Gallipoli Medical Research, Greenslopes Private Hospital, Brisbane