Klinische Studie
A Phase 3, Randomized, Open-label Study of MK-5684 Versus Alternative Abiraterone Acetate or Enzalutamide in Participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) That Progressed On or After Prior Treatment with One Nextgeneration Hormonal Agent (NHA)(OMAHA (MK-5684-004))Phase 3,Randomized,Open-label Study of MK-5684 Vs Alternative Abiraterone Acetate or Enzalutamide in Participants with mCRPC That Progressed On/After Prior Treatment with one NHA
Krankheitsentität(en)
Prostata
StudientypInterventionsstudiePhase III
StudientypInterventionsstudiePhase III
Wesentliche Einschlusskriterien1. 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. Prostate cancer progression will be determined by the investigator through 1 of the following:
• PSA progression shown by local laboratory values, as defined by a minimum of 2 consecutive rising PSA levels with an interval of ≥1 week between each assessment, where PSA at screening should be ≥1 ng/mL.
• Radiographic disease progression in soft tissue based on RECIST 1.1, with or without PSA progression.
• Radiographic disease progression in bone per PCWG, defined as the appearance of 2 or more new bone lesions on bone scan with or without PSA progression.
3. Have disease progression under the following conditions if the participant received first generation antiandrogen therapy before screening:
• Evidence of progression >4 weeks since the last flutamide treatment.
• Evidence of progression >6 weeks since the last bicalutamide or nilutamide treatment.
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).
Wesentliche Ausschlusskriterien1. 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.
Statusrekrutierend
Ansprechpartner & KontaktCaritas-Krankenhaus St. Josef RegensburgUrologieStudienzentrale0941 7823506uro-studienzentrum(at)csj.de