A Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (IDeate-Prostate01)
Summary
Researchers are looking for new ways to treat metastatic castration-resistant prostate cancer (mCRPC). Researchers have designed a study medicine called ifinatamab deruxtecan (also called I-DXd or MK-2400) to treat mCRPC. The goal of this study is to learn if people who receive I-DXd live longer overall and live longer without the cancer growing or spreading than people who receive chemotherapy.
Arms & interventions
- DrugIfinatamab deruxtecan
Administered via intravenous (IV) infusion every 3 weeks (q3w) until disease progression, unacceptable adverse events (AEs), or other cessation of treatment
- DrugDocetaxel
Administered via IV infusion q3W until disease progression, unacceptable adverse events (AEs), or other cessation of treatment
- DrugPrednisone
Oral tablet administered once per day or per approved product label
- DrugRescue Medication
Before administering each dose of I-DXd, premedication is required for prevention of nausea and vomiting with a 2 or 3 drug combination regimen (eg, corticosteroids with either a 5-HT3 receptor antagonist or an NK-1 receptor antagonist and other drugs as indicated) per approved product label
Outcome measures
Primary
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Time frame: Up to approximately 36 months
Radiographic Progression Free Survival (rPFS)
rPFS is defined as the time from randomization to the first documented disease progression per prostate cancer working group (PCWG)-modifed Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 by blinded independent central review (BICR) or death due to any cause, whichever occurs first.
Time frame: Up to approximately 36 months
Secondary
Time to First Subsequent Therapy (TFST)
Time frame: Up to approximately 36 months
Objective Response Rate (ORR)
Time frame: Up to approximately 36 months
Duration of Response (DOR)
Time frame: Up to approximately 36 months
Time to Pain Progression (TTPP)
Time frame: Up to approximately 36 months
Time to Prostate-specific Antigen (PSA) Progression
Time frame: Up to approximately 36 months
PSA Response Rate
Time frame: Up to approximately 36 months
Time to First Symptomatic Skeletal-Related Event (SSRE)
Time frame: Up to approximately 36 months
Number of Participants Who Experienced at Least One Adverse Event (AE)
Time frame: Up to approximately 36 months
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Time frame: Up to approximately 36 months
Eligibility criteria
Study locations (50)
Mayo Clinic in Arizona - Phoenix ( Site 0044)
Phoenix, Arizona, 85054
City of Hope Comprehensive Cancer Center ( Site 0049)
Duarte, California, 91010
City of Hope Lennar Foundation Cancer Center ( Site 0059)
Irvine, California, 92618
Moores Cancer Center ( Site 0010)
La Jolla, California, 92093
Cedars-Sinai Medical Center ( Site 0068)
Los Angeles, California, 90048
UCLA Hematology/Oncology - Santa Monica ( Site 0002)
Los Angeles, California, 90404
University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0006)
Orange, California, 92868
Stanford Cancer Center ( Site 0046)
Palo Alto, California, 94304
Rocky Mountain Regional Veterans Affairs Medical Center ( Site 0053)
Aurora, Colorado, 80045
Yale-New Haven Hospital-Yale Cancer Center ( Site 0050)
New Haven, Connecticut, 06510
Veterans Affairs Connecticut Healthcare System ( Site 0062)
West Haven, Connecticut, 06516
The GW Medical Faculty Associates ( Site 0057)
Washington D.C., District of Columbia, 20037
Washington DC Veterans Affairs Medical Center ( Site 0056)
Washington D.C., District of Columbia, 20422
Mayo Clinic in Florida-Mayo Clinic Comprehensive Cancer Center ( Site 0077)
Jacksonville, Florida, 32224
Emory University School of Medicine- Grady Campus ( Site 0103)
Atlanta, Georgia, 30303
Winship Cancer Institute, Emory University ( Site 0003)
Atlanta, Georgia, 30322
Rush University Medical Center-Hematology and Oncology ( Site 0028)
Chicago, Illinois, 60607
University of Illinois at Chicago-University of Illinois Cancer Center ( Site 0063)
Chicago, Illinois, 60612
University of Kentucky Chandler Medical Center ( Site 0048)
Lexington, Kentucky, 40536
Greenebaum Comprehensive Cancer Center ( Site 0021)
Baltimore, Maryland, 21201
Beth Israel Deaconess Medical Center ( Site 0043)
Boston, Massachusetts, 02215
Dana Farber Cancer Institute ( Site 0012)
Boston, Massachusetts, 02215
University of Michigan ( Site 0005)
Ann Arbor, Michigan, 48109
Henry Ford Hospital ( Site 0035)
Detroit, Michigan, 48202
Cancer and Hematology Centers of Western Michigan ( Site 0015)
Grand Rapids, Michigan, 49503
Mayo Clinic in Rochester, Minnesota-Mayo Clinic Comprehensive Cancer Center ( Site 0078)
Rochester, Minnesota, 55905
HealthPartners Cancer Research Center-HealthPartners Frauenshuh Cancer Center ( Site 0032)
Saint Louis Park, Minnesota, 55426
HealthPartners Cancer Center at Regions Hospital ( Site 0052)
Saint Paul, Minnesota, 55101
St. Vincent Frontier Cancer Center-Research ( Site 0037)
Billings, Montana, 59102
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Grand Island ( Site 0076)
Grand Island, Nebraska, 68803
Oncology Hematology West P.C. dba Nebraska Cancer Specialists ( Site 0026)
Omaha, Nebraska, 68130
Comprehensive Cancer Centers of Nevada ( Site 0082)
Las Vegas, Nevada, 89148
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0016)
Hackensack, New Jersey, 07601
University of New Mexico Comprehensive Cancer Center ( Site 0022)
Albuquerque, New Mexico, 87131
Icahn School of Medicine at Mount Sinai ( Site 0009)
New York, New York, 10029
Great Lakes Cancer Care ( Site 0047)
Williamsville, New York, 14221
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0061)
Columbus, Ohio, 43221
VA Portland Health Care System ( Site 0038)
Portland, Oregon, 97239
Perelman Center for Advanced Medicine ( Site 0067)
Philadelphia, Pennsylvania, 19104
Abramson Cancer Center - Penn Medicine ( Site 0079)
Philadelphia, Pennsylvania, 19106
Memphis VA Medical Center ( Site 0072)
Memphis, Tennessee, 38105
SCRI Oncology Partners ( Site 0074)
Nashville, Tennessee, 37203
Henry-Joyce Cancer Clinic ( Site 0042)
Nashville, Tennessee, 37232
UT Southwestern Medical Center ( Site 0039)
Dallas, Texas, 75390
University of Texas-MD Anderson Cancer Center ( Site 0055)
Houston, Texas, 77030
Blue Ridge Cancer Care ( Site 0024)
Roanoke, Virginia, 24014
VA Puget Sound Health Care System ( Site 0054)
Seattle, Washington, 98108
Fred Hutchinson Cancer Center ( Site 0060)
Seattle, Washington, 98109
University Hospital and UW Health Clinics ( Site 0065)
Madison, Wisconsin, 53792
Medical College of Wisconsin ( Site 0008)
Milwaukee, Wisconsin, 53226