Phase I Trial of 225Ac-J591 in Patients With mCRPC
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|ClinicalTrials.gov Identifier: NCT03276572|
Recruitment Status : Active, not recruiting
First Posted : September 8, 2017
Results First Posted : December 6, 2022
Last Update Posted : December 6, 2022
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: 225Ac-J591||Phase 1|
This clinical trial is for men with advanced prostate cancer. The purpose of this study is to find the highest dose level of the study drug, 225Ac-J591 that can be given without severe side effects. The research study is being done because the standard treatments for prostate cancer that has spread beyond the prostate gland are intended to minimize the adverse effects of the disease. These treatments, however, are not curative. Patients who choose to participate in this study will have a screening visit to determine whether or not they are eligible to participate in the study. The treatment phase is comprised of 8 visits over approximately 12 weeks. The study medication is called 225Ac-J591, and participants will receive an infusion of the study drug on the Treatment visit of the study. Upon completion of investigational treatment with single dose of 225Ac-J591, subjects will undergo 68Ga-PSMA-HBED-CC injection and same day PET/CT at the end of study visit to document treatment response. Subsequently survival data and additional treatment(s) information will be captured from their routine Standard of care (SOC) visits.During the other study visits, participants will undergo routine tests and procedures, such as physical examinations, and routine blood tests. Some blood tests will be done for research purposes only. After completion of therapy, participants may be contacted on a periodic basis to see how they are doing.
- Open to men age 18 and older.
- Diagnosis of progressive metastatic prostate cancer
- Have been previously treated for their disease with particular types of therapy.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Dose-Escalation Trial of 225Ac-J591 in Patients With Metastatic Castration-Resistant Prostate Cancer|
|Actual Study Start Date :||October 10, 2017|
|Actual Primary Completion Date :||January 7, 2021|
|Estimated Study Completion Date :||July 2024|
Experimental: All Subjects
A single dose of 225Ac-J591 will be given to subjects with documented progressive metastatic CRPC.
225Ac-J591 (13.3 KBq/Kg - 93.3 KBq/Kg or 0.36 uCi/Kg - 2.52 uCi/Kg) on day 1
Other Name: 68Ga-PSMA-HBED-CC injection for PET/CT Scan on day 1 and at end of study
- Number of Subjects With Dose Limiting Toxicities (DLT) [ Time Frame: Assessed from start of treatment to up to 8 weeks after first study drug administration. ]Count of participants will be measured by the recommended phase II dose in utilizing the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for DLTs.
- Number of Subjects Who Reached Maximum Tolerated Dose (MTD) [ Time Frame: Assessed from start of treatment to up to 8 weeks after first study drug administration. ]The MTD is the highest dose amongst the different dose-level cohorts in this study at which no more than 2 (33%) of the subjects in a cohort experience DLT.
- Number of Subjects With Prostate Specific Antigen (PSA) Response [ Time Frame: PSA was assessed at screening, and up to 6 months after first treatment with study drug. ]PSA will be analyzed through blood specimen collection
- Number of Subjects With Circulating Tumor Cells (CTC) Response [ Time Frame: CTC was assessed at screening and 12 weeks after starting study drug. ]CTCs will be analyzed through blood specimen collection via CellSearch methodology lab testing
- Number of Subjects With Radiographic (Imaging) Response [ Time Frame: Response were assessed for patients throughout their duration on the study, up to 3 years. ]Radiographic response rate by Response evaluation criteria in solid tumors (RECIST) criteria with Prostate Cancer Working Group 3 (PCWG3) modifications
- Progression Free Survival (PFS) [ Time Frame: From the start of treatment to progression, up to 3 years ]Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03276572
|United States, Louisiana|
|Tulane Cancer Center Clinic|
|New Orleans, Louisiana, United States, 70112|
|United States, New York|
|Weill Cornell Medical College|
|New York, New York, United States, 10065|
|Principal Investigator:||Scott Tagawa, MD||Weill Medical College of Cornell University|