PROSTATE: METASTATIC: Castration Resistant: 2nd Line Hormonal: MK-5684-004

Study snapshot

Title: Merck MK-5684-004 mCRPC post 1 endocrine therapy
Malignancy: Prostate Cancer
Stage: Stage 4
Disease setting: Metastatic/Palliative
Line of therapy: 2nd Line Hormonal Therapy
Investigational agent: MK-5684
Drug class: CYP11A1 inhibitor
Principal investigator: Brad Somer, MD
Sponsor: Merck Sharp and Dohme
Path: Castration-Resistant
Randomized: Yes
ClinicalTrials.gov ID: NCT06136650

Eligibility and objectives

Key eligibility criteria details

Have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology
Has current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease shown by computed tomography scan (CT)/magnetic resonance imaging (MRI)
Has prostate cancer progression while receiving androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months before Screening
Has disease that progressed during or after treatment with one next-generation hormonal agent (NHA) for hormone sensitive prostate cancer (HSPC) metastatic hormone sensitive prostate cancer (mHSPC) or non metastatic hormone sensitive prostate cancer (nmHSPC), 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 six cycles of docetaxel and had no radiographic disease progression while receiving docetaxel
ECOG PS 0-1
Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<1.7 nM)
Has had prior treatment with Poly polymerase inhibitors (PARPi) or were deemed ineligible to receive treatment by the investigator or have refused PARPi treatment
Has adequate organ function
Has provided tumor tissue from a fresh core or excisional biopsy from soft tissue not previously irradiated. Samples from tumors progressing at a prior site of radiation are allowed
Participants who have adverse event (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement therapy (HRT) or participants who have ≤Grade 2 neuropathy are eligible
Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
No presence of gastrointestinal condition
No history of pituitary dysfunction
No poorly controlled diabetes mellitus
No active or unstable cardio/cerebro-vascular disease, including thromboembolic events
Has not received a taxane-based chemotherapy and or NHA for metastatic castration-resistant prostate cancer (mCRPC)
Has not received prior treatment with radium for prostate cancer
Does not have a "superscan" bone scan defined as an intense symmetric activity in the bones and diminished renal parenchymal activity on baseline bone scan such that the presence of additional metastases in the future could not be evaluated
Has known additional malignancy that is progressing or has required active treatment within the past 3 years
No known active central nervous system (CNS) metastases

Objective

Primary
- radiologic PFS
- OS
Secondary
- TFST
- ORR
- DOR
- Time to pain progression
- Time to PSA progression
- Time to first symptomatic skeletal related event
- Safety

Study snapshot

Eligibility and objectives

Key eligibility criteria details

Objective

Treatment details