Phase 3 Study of MK-5684 Versus Alternative Treatment with an NHA in mCRPC After Treatment with an NHA

Phase 3

Conditions: D075 Prostate
Prostate
D075

Registration Number: PER-047-23

Lead Sponsor: Merck Sharp & Dohme LLC., (una subsidiaria de Merck & Co. Inc.)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Without startig enrollment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Participant type and disease characteristics
Has histologically or cytologically confirmed prostate adenocarcinoma without small cell histology (if acceptable according to local health authority regulations). The diagnosis must be established in a pathology report and confirmed by the investigator.

Participant type and disease characteristics
Has prostate cancer progression while receiving ADT (or after bilateral orchiectomy) within 6 months prior to screening. The investigator will determine prostate cancer progression using 1 of the following:
• PSA progression based on local laboratory values, defined as 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. See Section 8.2.2 for additional information.
Note: A PSA level obtained during the screening period may count as the second confirmatory rising PSA.
• Radiographic progression of the disease in soft tissues according to RECIST 1.1, with or without PSA progression.
• Radiographic disease progression in bone according to PCWG, defined as the appearance of 2 or more new bone lesions on bone imaging with or without PSA progression.

Participant type and disease characteristics
Has disease progression under the following conditions if the participant received first-generation antiandrogen therapy prior to screening:
• Evidence of progression >4 weeks since last flutamide treatment.
• Evidence of progression >6 weeks since last treatment with bicalutamide or nilutamide.

Participant type and disease characteristics
Has current evidence of metastatic disease documented by bone lesions on bone imaging and/or soft tissue disease visible on CT/MRI.

Participant type and disease characteristics
You have disease that has progressed during or after treatment with an NHA (e.g., 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).
Note: Participants may have received abiraterone acetate and docetaxel or darolutamide and docetaxel for HSPC. However, participants must have received no more than 6 cycles of docetaxel and must not have had radiographic disease progression while receiving docetaxel.

Participant type and disease characteristics
Have received prior treatment with PARPi or have been deemed unsuitable for treatment by the investigator or have refused treatment with PARPi.

Participant type and disease characteristics
Has 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 had an orchiectomy), this treatment must have been started at least 4 weeks before the randomization date and the Treatment should continue throughout the study.

Exclusion Criteria

Medical conditions
Has a gastrointestinal condition; for example, malabsorption, which may affect the absorption of the study medication.

Medical conditions
Cannot swallow capsules/tablets.

Medical conditions
History of pituitary dysfunction.
Note: Exceptions may be considered after consulting Sponsor.

Medical conditions
Poorly controlled diabetes mellitus.

Medical conditions
Clinically significant abnormal serum potassium or sodium level.

Medical conditions
You present any of the following symptoms at the screening visit:
• Hypotension: for systolic <110 mmHg; or
• Uncontrolled hypertension: for systolic =160 mmHg or for diastolic =90 mmHg, in 2 of 3 records with optimized antihypertensive treatment.

Medical conditions
Have active or unstable cardiovascular or cerebrovascular disease, including thromboembolic events.
Examples: recent myocardial infarction (within 6 months), coronary artery bypass graft, or symptomatic stroke or congestive heart failure (New York Heart Association class III-IV).

Medical conditions
History or family history of long QTc syndrome.

Medical conditions
Has a resting ECG that indicates unmonitored and possibly reversible cardiac conditions at the discretion of the investigator (e.g., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation >470 ms, electrolyte disturbances, etc.) or have congenital long QT syndrome.

Medical conditions
Have a history of seizures within 6 months prior to providing documented informed consent or have a condition that could predispose you to seizures within 12 months prior to the date of enrollment, including, but not limited to, loss of consciousness or previous stroke, transient ischemic attack or cerebral arteriovenous malformation, or intracranial tumor, such as schwannoma or meningioma, that is causing edema or mass effect.

Medical conditions
You have a history of clinically significant ventricula

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
on-parametric Kaplan-Meier method<br> NAME OF THE RESULT: Efficacy endpoint:<br>Radiographic progression-free survival (rPFS)<br> PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE<br> PRIMARY RESULT: Time from randomization to first documented disease progression as assessed by blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) modified by the Prostate Cancer Working Group (PCWG) or death from any cause, whichever comes first. ;Non-parametric Kaplan-Meier method<br> NAME OF THE RESULT: Efficacy endpoint:<br>Overall survival (OS)<br> PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE<br> PRIMARY RESULT: Time from randomization to death from any cause.

Secondary Outcome Measures