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
Last Update Posted : March 4, 2021
|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 :||31 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
- Change in the number of subjects with dose limiting toxicities (DLT) [ Time Frame: Will be collected at the time of visit 1 through end of study or 100 months ]DLTs will be measured by the recommended phase II dose in utilizing the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
- Maximum tolerated dose (MTD) [ Time Frame: Will be collected at the time of visit 1 through end of study or 100 months ]The dose that produces an "acceptable" level of toxicity or that, if exceeded, would put subjects at "unacceptable" risk for toxicity. Definition of the MTD usually relies on the sample, as MTD is defined as the dose level at which no more than two patients out of six experienced dose-limiting toxicity (DLT).
- Change in prostate specific antigen (PSA) response [ Time Frame: Samples will be collected at Screening, Day 1, Day 8, Day 15, Day 29, Day 57, Day 85 then then every 4 weeks for 3 visits ]PSA will be analyzed through blood specimen collection
- Change in circulating tumor cells (CTC) response [ Time Frame: Samples will be collected at Screening, Day 1 and Day 85 visit then every 4 weeks for 3 visits ]CTCs will be analyzed through blood specimen collection via CellSearch methodology lab testing
- Change in the number of subjects with radiographic (imaging) response [ Time Frame: Scans will be performed at Screening and Day 85 ]Radiographic response rate by Response evaluation criteria in solid tumors (RECIST) criteria with Prostate Cancer Working Group 3 (PCWG3) modifications
- Change in the number of subjects in patient reported outcomes (PRO) through Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire [ Time Frame: Samples will be collected at Screening, Day 1, Day 8, Day 15, Day 29, Day 57, Day 85 then then every 4 weeks for 3 visits ]Functional Assessment of Cancer Therapy-Prostate or FACT-P questionnaire is a commonly used patient reported outcome that looks at health-related quality of life in men with prostate cancer. The FACT-p scale is measured from a minimum of 0 (little to no difficulty) to a maximum of 4(very difficult).
- Change in the number of subjects in patient reported outcomes(PRO) through Brief Pain Inventory (BPI) short form [ Time Frame: Samples will be collected at Screening, Day 1, Day 8, Day 15, Day 29, Day 57, Day 85 then then every 4 weeks for 3 visits ]BPI is a questionnaire is utilized to assess the severity of pain and the impact it has on daily functioning. The scale is based on a rating of 0-10
- Change in Biochemical and radiographic progression-free survival (PFS) [ Time Frame: Scans will be captured at Screening and Day 85 then every 4 weeks for 3 visits then every 6 months for 3 years ]Radiographic evaluation will include bone scan, CT/MRI of abdomen/pelvis, and Chest x-ray (waived if CT/MRI includes chest). Prostate Cancer Working Group 3(PCWG3) modification will be utilized
- Overall survival (OS) following single dose of 225Ac-J591 [ Time Frame: Survival will be collected from Day1 through study completion up to 100 months ]Overall survival will be captured through in-clinic or telephone contact with subjects
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|