Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06925737
Registration number
NCT06925737
Ethics application status
Date submitted
7/04/2025
Date registered
13/04/2025
Date last updated
27/06/2025
Titles & IDs
Public title
A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)
Query!
Scientific title
A Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (IDeate-Prostate01)
Query!
Secondary ID [1]
0
0
U1111-1312-2498
Query!
Secondary ID [2]
0
0
2400-001
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer
0
0
Query!
Prostatic Neoplasms
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Prostate
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Ifinatamab deruxtecan
Treatment: Drugs - Docetaxel
Treatment: Drugs - Prednisone
Experimental: I-DXd - Participants receive I-DXd 12mg/kg every 3 weeks (q3w)
Active comparator: Docetaxel - Participants receive docetaxel 75 mg//m\^2 q3w and prednisone 10 mg/day or per approved product label
Treatment: Drugs: Ifinatamab deruxtecan
Administered via intravenous (IV) infusion every 3 weeks (q3W) until disease progression, unacceptable adverse events (AEs), or other cessation of treatment
Treatment: Drugs: Docetaxel
Administered via IV infusion q3W until disease progression, unacceptable adverse events (AEs), or other cessation of treatment
Treatment: Drugs: Prednisone
Oral tablet administered once per day or per approved product label
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Overall Survival (OS)
Query!
Assessment method [1]
0
0
OS is defined as the time from randomization to death due to any cause.
Query!
Timepoint [1]
0
0
Up to approximately 36 months
Query!
Primary outcome [2]
0
0
Radiographic Progression Free Survival (rPFS)
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Up to approximately 36 months
Query!
Secondary outcome [1]
0
0
Time to First Subsequent Therapy (TFST)
Query!
Assessment method [1]
0
0
TFST is defined as the time from randomization to initiation of the first subsequent anticancer therapy or death, whichever occurs first.
Query!
Timepoint [1]
0
0
Up to approximately 36 months
Query!
Secondary outcome [2]
0
0
Objective Response (OR)
Query!
Assessment method [2]
0
0
The OR is defined as a confirmed complete response (CR) or partial response (PR) per PCWG-modified RECIST 1.1 as assessed by BICR.
Query!
Timepoint [2]
0
0
Up to approximately 36 months
Query!
Secondary outcome [3]
0
0
Duration of Response (DOR)
Query!
Assessment method [3]
0
0
For participants who demonstrate confirmed CR or PR, DOR is defined as the time from the first documented evidence of CR or PR until disease progression per PCWG-modified RECIST 1.1 as assessed by BICR or death due to any cause, whichever occurs first.
Query!
Timepoint [3]
0
0
Up to approximately 36 months
Query!
Secondary outcome [4]
0
0
Time to Pain Progression (TTPP)
Query!
Assessment method [4]
0
0
TTPP is defined as the time from randomization to pain progression based on the brief pain inventory-short form (BPI-SF) Item 3 "worst pain in 24 hours" and opiate analgesic use (AQA score).
Query!
Timepoint [4]
0
0
Up to approximately 36 months
Query!
Secondary outcome [5]
0
0
Time to Prostate-specific Antigen (PSA) Progression
Query!
Assessment method [5]
0
0
Time to PSA progression is defined as the time from randomization to PSA progression. The PSA progression date is defined as the first date that 1) =25% increase and =2 ng/mL above the nadir which is confirmed by a second value=3 weeks later if there is PSA decline from baseline, 2) =25% increase and =2 ng/mL increase from baseline beyond 12 weeks if there is no PSA decline from baseline.
Query!
Timepoint [5]
0
0
Up to approximately 36 months
Query!
Secondary outcome [6]
0
0
PSA Response
Query!
Assessment method [6]
0
0
PSA response rate is defined as the proportion of participants in the analysis population who have a PSA reduction of =50% from baseline with a consecutive confirmation assessment at least 3 weeks later per PCWG criteria
Query!
Timepoint [6]
0
0
Up to approximately 36 months
Query!
Secondary outcome [7]
0
0
Time to First Symptomatic Skeletal-related Event (SSRE)
Query!
Assessment method [7]
0
0
Time to first SSRE is defined as the time from randomization to the first occurrence of any of the following symptomatic skeletal-related events: 1. use of EBRT to prevent or relieve skeletal symptoms, 2. new symptomatic pathologic bone fracture (vertebral or non-vertebral), 3. spinal cord compression, 4. a tumor-related orthopedic surgical intervention.
Query!
Timepoint [7]
0
0
Up to approximately 36 months
Query!
Secondary outcome [8]
0
0
Number of Participants Who Experienced at least One Adverse Event (AE)
Query!
Assessment method [8]
0
0
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Query!
Timepoint [8]
0
0
Up to approximately 36 months
Query!
Secondary outcome [9]
0
0
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Query!
Assessment method [9]
0
0
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Query!
Timepoint [9]
0
0
Up to approximately 36 months
Query!
Eligibility
Key inclusion criteria
The main inclusion criteria include but are not limited to the following:
* Has diagnosis of metastatic castration-resistant prostate cancer (mCRPC)
* Has prostate cancer progression while on androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months prior to entering the study
* Has received prior treatment with 1 or 2 androgen receptor pathway inhibitor (ARPI) and progressed during or after at least 8 weeks of treatment
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Males
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
The main exclusion criteria include but are not limited to the following:
* History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids
* Has uncontrolled or significant cardiovascular disease
* Has received prior treatment with a taxane-based chemotherapy agent for mCRPC
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
13/05/2025
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
6/01/2031
Query!
Actual
Query!
Sample size
Target
1440
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
0
0
Peter MacCallum Cancer Centre ( Site 0152) - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
3000 - Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Michigan
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Minnesota
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Montana
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Nebraska
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
New Jersey
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Virginia
Query!
Country [7]
0
0
Argentina
Query!
State/province [7]
0
0
La Rioja
Query!
Country [8]
0
0
Guatemala
Query!
State/province [8]
0
0
Guatemala City
Query!
Country [9]
0
0
Guatemala
Query!
State/province [9]
0
0
Guatemala
Query!
Country [10]
0
0
Israel
Query!
State/province [10]
0
0
Haifa
Query!
Country [11]
0
0
Israel
Query!
State/province [11]
0
0
Petah Tikva
Query!
Country [12]
0
0
Israel
Query!
State/province [12]
0
0
Ramat Gan
Query!
Country [13]
0
0
Israel
Query!
State/province [13]
0
0
Tel Aviv
Query!
Country [14]
0
0
Japan
Query!
State/province [14]
0
0
Osaka
Query!
Country [15]
0
0
Japan
Query!
State/province [15]
0
0
Kumamoto
Query!
Country [16]
0
0
Japan
Query!
State/province [16]
0
0
Nagano
Query!
Country [17]
0
0
Korea, Republic of
Query!
State/province [17]
0
0
Seoul
Query!
Country [18]
0
0
Korea, Republic of
Query!
State/province [18]
0
0
Ulsan-Kwangyokshi
Query!
Country [19]
0
0
Taiwan
Query!
State/province [19]
0
0
Taipei
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Merck Sharp & Dohme LLC
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/industry
Query!
Name [1]
0
0
Daiichi Sankyo
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief 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,
Query!
Trial website
https://clinicaltrials.gov/study/NCT06925737
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Medical Director
Query!
Address
0
0
Merck Sharp & Dohme LLC
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Toll Free Number
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
1-888-577-8839
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06925737
Download to PDF