Clinical trial • Phase I • Oncology

225Ac-PSMA I&T for Metastatic prostate cancer

Phase I trial of 225Ac-PSMA I&T for Metastatic prostate cancer. None/Not specified-controlled. 30 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Metastatic prostate cancer
Trial Stage
Phase I
Drug Modality
Radiopharmaceutical

Key dates

Initial CTIS Submission Date
05-09-2024
First CTIS Authorization Date
24-09-2024

Trial design

None/Not specified-controlled Phase I trial across 1 site in Netherlands.

Comparator
None/Not specified
Target Sample Size
30

Eligibility

Recruits 30 Vulnerable populations not selected; no information on consent or assent handling provided..

Vulnerable Population
Vulnerable populations not selected; no information on consent or assent handling provided.

Recruitment

Planned Sample Size
30
Recruitment Window Months
45

Geography

Total Number Of Sites
1
Total Number Of Participants
30

Netherlands

Earliest CTIS Part Ii Submission Date
18-09-2024
Latest Decision Or Authorization Date
24-09-2024
Processing Time Days
6
Number Of Sites
1
Number Of Participants
30

Sites

Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Radiology and Nuclear Medicine
Contact Person Name
Tessa Brabander
Contact Person Email
t.brabander@erasmusmc.nl
Number Of Participants
30

Sponsor

Primary sponsor

Full Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

Investigational products

Investigational Product Name
225Ac-PSMA I&T
Active Substance
225Ac-PSMA I&T
Modality
Radiopharmaceutical

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