Clinical Trial for Metastatic Castrate Resistant Prostate Cancer (mCRPC) and Prostate Cancer (Adenocarcinoma).

Who may participate

Each clinical study has its own guidelines for who may participate, called eligibility criteria. These factors can include your age, sex, overall health, type and stage of disease, and personal treatment history. However, only the research study staff can determine if you qualify to enroll in the study.

Condition

Metastatic Castrate Resistant Prostate Cancer (mCRPC), Prostate Cancer (Adenocarcinoma)

Sex

Male

Age

18+ years

Healthy participants

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Eligibility criteria

Inclusion criteria

Willing and able to provide written informed consent
Age 18 years or older
Diagnosis of prostate cancer (adenocarcinoma) confirmed by tissue sample, without neuroendocrine or small cell features
Currently taking or recently treated with enzalutamide, darolutamide, or apalutamide (within 30 days of screening) and willing to switch to or restart enzalutamide for this study
Cancer has spread to bone or soft tissue (metastatic disease), confirmed by imaging
ECOG performance status of 0, 1, or 2 (able to care for self and up and about more than 50% of waking hours)
Testosterone level less than 50 ng/dL at screening, with ongoing hormone deprivation therapy or prior surgical castration
If receiving bone-protective therapy (e.g., denosumab or bisphosphonates), must be on a stable dose for at least 4 weeks
Evidence of cancer progression while on enzalutamide, darolutamide, or apalutamide, shown by rising PSA, worsening disease on imaging, or new bone lesions
Adequate organ function based on blood tests within 28 days of starting treatment, including adequate blood counts, kidney function, and liver function
Willing to use acceptable birth control during the study and for 30 days after the last dose

Exclusion criteria

History of myelodysplastic syndrome, acute myeloid leukemia, or other prior cancer (exceptions: non-melanoma skin cancer, carcinoma in situ, cancers more than 3 years ago with no recurrence, or early-stage cancers with low risk of recurrence)
Any medical or psychiatric condition, including active infection or recent suicidal ideation, that may make study participation unsafe
History of seizure or conditions that may increase seizure risk (e.g., prior stroke, significant brain trauma), or loss of consciousness or transient ischemic attack within 12 months
Untreated brain metastases, spinal cord compression, or clinically significant epidural disease
Use of 5-alpha reductase inhibitors, herbal medications, or supplements known to alter PSA levels within 4 weeks of starting treatment
AIDS-related illness or active hepatitis B or C (well-controlled HIV is allowed)
Known history of chronic liver disease (e.g., alcoholic liver disease, primary biliary cirrhosis, autoimmune hepatitis, Wilson's disease, hemochromatosis)
Known history of active inflammatory gastrointestinal disease, chronic diarrhea, or prior gastric resection or lap-band surgery
Clinically significant cardiovascular disease within the past 6 months (e.g., heart attack, unstable angina, stroke, heart failure NYHA Class III/IV, pulmonary embolism, significant arrhythmias), cardiac pacemaker, or QTcF greater than 480 msec on screening ECG
Prior or current use of PARP inhibitors and/or AKT inhibitors
Prior cancer progression on abiraterone (stopping abiraterone due to side effects is allowed)
Known allergy to any study drug
Blood transfusion within 28 days prior to screening blood tests
Use of another investigational drug within 4 weeks before starting study treatment
Any other condition that, in the opinion of the investigator, would prevent safe participation
Current use or anticipated need for strong CYP3A4/5 inhibitors or inducers (other than enzalutamide) within 10 days or 5 half-lives prior to treatment start

Study overview

The purpose of this study is to find out whether mevrometostat in combination with enzalutamide delays cancer progression in people with metastatic castration-resistant prostate cancer (mCRPC) who have previously received enzalutamide, darolutamide, or apalutamide in the metastatic castration-sensitive prostate cancer (mCSPC) or non-metastatic castration-resistant prostate cancer (nmCRPC) setting but have not previously progressed on abiraterone.

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A Study of Mevrometostat With Enzalutamide in People With Prostate Cancer Who Have Previously Received Androgen Receptor Pathway Inhibitor Therapy

Who may participate

Eligibility criteria

Study overview

View locations for this study

Nearest Locations found

Join PfizerConnect

A Study of Mevrometostat With Enzalutamide in People With Prostate Cancer Who Have Previously Received Androgen Receptor Pathway Inhibitor Therapy

Who may participate

Eligibility criteria

Study overview

View locations for this study

Nearest Locations found

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