Study on Combining Mevrometostat with Enzalutamide for Treating Metastatic Castration-Sensitive Prostate Cancer
Sponsor: Pfizer
ClinicalTrials ID:NCT07028853
This clinical trial is testing whether adding the investigational drug mevrometostat to the standard treatment enzalutamide is more effective than using enzalutamide alone for patients with metastatic castration-sensitive prostate cancer (mCSPC) who have not previously received certain treatments.
Patient Parameters
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Program Overview
The purpose of this study is to find out if combining the investigational drug mevrometostat with enzalutamide works better than enzalutamide alone in treating patients with metastatic castration-sensitive prostate cancer (mCSPC) who have not received chemotherapy or other advanced prostate cancer treatments.
Description
This is a large, international study involving multiple centers. It is designed to compare two treatment options for patients with metastatic castration-sensitive prostate cancer (mCSPC). Participants will be randomly assigned to one of two groups: one group will receive the investigational drug mevrometostat along with enzalutamide, while the other group will receive a placebo (a substance with no active drug) along with enzalutamide. The study is double-blind, meaning neither the participants nor the researchers will know who is receiving the investigational drug or the placebo.
The study includes several phases: a Screening Phase to determine eligibility, a Randomization Phase to assign participants to a treatment group, a Treatment Phase where participants receive their assigned treatment, a Safety Follow-up to monitor for any side effects, and a Long-Term Follow-up to track the participants' health over time.
Participants are eligible if they have not received any systemic anticancer treatments for mCSPC, except for androgen-deprivation therapy (ADT) and first-generation antiandrogen agents. They may have had up to 3 months of ADT, as long as there is no evidence of disease progression or rising PSA levels before starting the study treatment.
Eligibility Criteria
Inclusion Criteria
- Male participants aged ≥18 years (or the minimum age of consent in accordance with local regulations) at screening.
- Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features.
- Metastatic prostate cancer documented by positive bone scan (for bone disease) or metastatic lesion(s) on CT or MRI (for soft tissue/visceral disease).
- Resolution of acute effects of any prior therapy to either baseline severity or CTCAE Grade ≤1 (except for AEs which do not constitute a safety risk in the investigator's judgement).
- Participants must have ECOG PS 0 or 1.
Exclusion Criteria
- Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- Clinically significant cardiovascular disease.
- Known or suspected brain metastasis or active leptomeningeal disease.
- Participants must be treatment naïve at the mCSPC stage, eg, participants cannot have received any cytotoxic chemotherapy with the following exceptions: Treatment with first-generation antiandrogen (ADT) agents is allowed for mCSPC.
- Previous administration with an investigational product (drug or vaccine) within 30 days.
- Current use or anticipated need for drugs that are known strong CYP3A4/5 inhibitors and inducers (with exception of enzalutamide as part of this study).
- Inadequate organ function.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Ironwood Cancer & Research Centers | 85224 | Chandler | Arizona |
| Ironwood Cancer & Research Centers | 85297 | Gilbert | Arizona |
| Ironwood Cancer & Research Centers | 85306 | Glendale | Arizona |
| Ironwood Cancer & Research Centers | 85395 | Goodyear | Arizona |
| Ironwood Cancer & Research Centers | 85202 | Mesa | Arizona |
| Ironwood Cancer & Research Centers | 85206 | Mesa | Arizona |
| Ironwood Cancer & Research Centers | 85028 | Phoenix | Arizona |
| Ironwood Cancer & Research Centers | 85260 | Scottsdale | Arizona |
| Highlands Oncology Group, PA | 72703 | Fayetteville | Arkansas |
| Highlands Oncology Group, PA | 72758 | Rogers | Arkansas |
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