Principal Investigator:
Study sponsor: Merck Sharpe & Dohme LLC
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: III
Purpose of study: The purpose of this study is to test the safety and effectiveness of the study drug MK-5684 combined with hormone replacement therapy (HRT) compared to alternative Abiraterone acetate or Enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC).
Inclusion Criteria:
– Have histologically or cytologically confirmed adenocarcinoma of prostate without small cell histology.
– Have current evidence of metastatic disease documented either by bone lesions on bone scan, or by soft tissue disease documented by CT or MRI scan.
– Has prostate cancer progression while receiving androgen deprivation therapy.
– Has had disease progress during or after treatment with one next-generation hormonal agent.
– Has ECOG of 0 – 1.
– Has adequate organ function as determined by lab tests.
– Has provided tumor tissue from fresh core or excisional biopsy from soft tissue that was not previously radiated.
– Participants that test positive for Hepatitis B are eligible if they have received antiviral therapy for at least 4 weeks, and have undetectable load prior to randomization. Additionally, participants with Hepatitis C are eligible if viral load is undetectable at screening.
– HIV positive patients must be on well controlled antiretroviral therapy.
– Additional criteria may apply and will be discussed with the study team and physician.
Exclusion Criteria:
– Has other Gastrointestinal condition
– Unable to swallow capsules/tablets
– Has poorly controlled diabetes mellitus
– Has active or unstable cardio/Cerebro-vascular disease or thromboembolic events.
– Has significant abnormal sodium or potassium levels, or hypotension at screening.
– History or family history of long QTc Syndrome.
– Has history of seizures within 6 months prior to signing consent, or condition that may predispose to seizures within 12 months prior to signing consent.
– Has previously received Taxane-based chemotherapy or next-generation hormonal agent for metastatic castration-resistant prostate cancer.
– Has not recovered from previous major surgery or has ongoing surgical complications.
– Has received prior treatment with Radium for prostate cancer.
– Has received CYP450-inducing antiepileptic drugs for seizure.
– Has received radiotherapy within 2 weeks prior to first dose of study drug.
– Is on an unstable dose of thyroid hormone therapy within 6 months prior to first dose of study drug.
– Has received prior systemic therapy including other investigational drugs, or investigational devices within 4 weeks prior to first dose of study drug.
– Has received a live or live-attenuated vaccine within 30 days prior to first dose of study drug.
– Has known hypersensitivity to components or excipients in abiraterone acetate, prednisone or prednisolone, or enzalutamide.
– Has known other malignancy that is progressing or has required active treatment within the past 3 years.
– Is receiving chronic systemic steroid therapy (>10mg / day of prednisone or equivalent).
– Has known central nervous system metastases. Patients with previously treated brain Mets may participate if they have been radiologically stable for 4 weeks and have not required steroid treatment for at least 14 days prior to first dose of study drug.
– Has active autoimmune disease that required systemic treatment in the last 2 years.
– Has active infection that requires treatment.
– Has concurrent Hepatitis B and Hepatitis C virus infection.
– Additional criteria may apply and will be discussed with the study team and physician.
Study Contact:
Alissa Gavenda, RN
(952) 992-5705
Alissa.Gavenda@ParkNicollet.com
