Clinical Trials List
2025-08-01 - 2035-08-31
Phase III
Recruiting6
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Mevrometostat (PF-06821497) With Enzalutamide in Metastatic Castration-Sensitive Prostate Cancer (MEVPRO-3)
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 張瓈文 Division of Urology
- Chia-Yen Lin Division of Urology
- JU-CHUAN HU Division of Urology
- 王樹吉 Division of Urology
- 張家程 Division of Urology
- 林雁婷 Division of Urology
- 裘坤元 Division of Urology
- 洪晟鈞 Division of Urology
- Jian-Ri Li Division of Urology
- Chuan-Shu Chen Division of Urology
- 楊哲瑞 Division of Urology
- 楊涵中 Division of Urology
- 賴谷順 Division of Urology
- Cheng-Kuang Yang Division of Urology
- 梅承恩 Division of Urology
- Shian-Shiang Wang Division of Urology
- 蔡世傳 Division of Urology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Hong-Cheng Gan 無
- PO-HUNG LIN 無
- 余紹銘 無
- 沈鼎文 無
- Feng-Yuan Liu 無
- 張境夫 無
- Yung-Chia Kao 無
- Kai-Jie Yu 無
- 黃文冠 無
- I-hung Shao 無
- See-Tong Pang 無
- Yung-Chang Lin 無
- 吳俊德 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Jiun-I Lai 無
- Tzu-Hao Huang 無
- I-Shen Huang 無
- 沈書慧 Division of Urology
- Jia-An Hong 無
- 蔡承翰 無
- Chien-Hsin Ting 無
- Chih-Chieh Lin 無
- Yen-Hwa Chang 無
- Tzu-chun Wei 無
- William Huang 無
- Yi-Hsiu Huang 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 闕士傑 無
- - - 無
- YEN-HENG LIN 無
- FU-JEN HSUEH 無
- 王中傑 無
- PO-MING CHOW 無
- YU-CHUAN LU 無
- 吳書丞 無
- 張尚仁 無
- Yu-Chieh Tsai 無
- Ying-Chun Shen 無
- JHE-CYUAN GUO 無
- JIAN-HUA HONG 無
- CHING-CHU LU 無
- Yeong-Shiau Pu 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Hsin-Chih Yeh 無
- Wen-Jeng Wu 無
- Ching-Chia Li 無
- 阮雍順 無
- 李明儒 無
- 張顥瀚 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Capsules
Active Ingredient
Enzalutamide
Dosage Form
130
Dosage
40 mg
Endpoints
Inclution 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.
The Estimated Number of Participants
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Taiwan
50 participants
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Global
1000 participants