Cancer
Conditions
Interventions
MK5684
Abiraterone
Enzalutamide
Sponsors
MSD Pty Ltd
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Have histologically or cytologically confirmed (if acceptable according to local health authority regulations) adenocarcinoma of the prostate without small cell histology. The diagnosis must be stated in a pathology report and confirmed by the investigator. 2. Have prostate cancer progression while receiving ADT (or post bilateral orchiectomy) within 6 months before screening. 3. Have disease progression under the following conditions if the participant received first generation antiandrogen therapy before screening 4. Have current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease shown by CT/MRI. 5. Have disease that progressed during or after treatment with one NHA (eg, abiraterone acetate, enzalutamide, apalutamide, darolutamide) for HSPC (mHSPC or nmHSPC), or nmCRPC, for at least 8 weeks (at least 14 weeks for participants with bone progression). 6. Have had prior treatment with PARPi or were deemed ineligible to receive treatment by the investigator or have refused PARPi treatment 7. Have ongoing ADT with serum testosterone <50 ng/dL (<1.7 nM). If the participant is currently being treated with luteinizing hormone-releasing hormone agonists or antagonists (in participants who have not undergone orchiectomy), this therapy must have been initiated at least 4 weeks before the date of randomization, and treatment must be continued throughout the study. 8. Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses for =4 weeks before randomization. 9. Have an ECOG performance status of 0 or 1 assessed within 7 days before randomization. 10. Adequate organ function. 11. Is at least 18 years of age at the time of providing informed consent.
Exclusion criteria
Exclusion criteria: 1. Has presence of gastrointestinal condition, eg, malabsorption, that might affect the absorption of study medication. 2. Is unable to swallow capsules/tablets. 3. History of pituitary dysfunction. Note: Exceptions may be considered after Sponsor consultation. 4. Poorly controlled diabetes mellitus. 5. Clinically significant abnormal serum potassium or sodium level. 6. Has any of the following at Screening Visit: • Hypotension: systolic BP 470 msec, electrolyte disturbances, etc.), or has congenital long QT syndrome. 10. Has a history of seizure(s) within 6 months before providing documented informed consent or has any condition that may predispose to seizure within 12 months before the date of enrollment, including, but not limited to loss of consciousness or prior cerebrovascular accident, transient ischemic attack, or brain arteriovenous malformation; or intracranial masses such as a schwannoma or meningioma that is causing edema or mass effect. 11. Has a history of clinically significant ventricular arrhythmias (eg, ventricular tachycardia, ventricular fibrillation, torsades de pointes) or Mobitz II second degree or third-degree heart block without a permanent pacemaker in place. 12. Has received a taxane-based chemotherapy and or NHA for mCRPC. 13. Participants who received a total of more than one NHA before enrollment are not eligible (this includes nmHSPC, mHSPC, and nmCRPC).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival: The time from randomization to death due to any cause;Progression Free Survival : The time from randomization to radiographic progression or death due to any cause, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| TFST the time from randomization to initiation of the first subsequent anticancer therapy or death, whichever occurs first.;OR confirmed complete response or partial response. DOR the time from the earliest date of first documented evidence of confirmed CR or PR until the earliest date of disease progression or death from any cause, whichever comes first. | — |
Countries
Kenya, South Africa
Contacts
Public ContactUrmilla Bridgmohun
Therapeutic Area Head
Outcome results
None listed