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Radioisotope Therapy

225Ac-J591 for Prostate Cancer

Phase 1
Waitlist Available
Led By Scott Tagawa, MD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the start of treatment to progression, up to 3 years
Awards & highlights

Study Summary

This trial is testing a new cancer treatment to determine the maximum tolerated dose while minimizing side effects.

Eligible Conditions
  • Prostate Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the start of treatment to progression, up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the start of treatment to progression, up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Subjects Who Reached Maximum Tolerated Dose (MTD)
Number of Subjects With Dose Limiting Toxicities (DLT)
Secondary outcome measures
Number of Subjects With Circulating Tumor Cells (CTC) Response
Number of Subjects With Prostate Specific Antigen (PSA) Response
Number of Subjects With Radiographic (Imaging) Response
+1 more

Side effects data

From 2023 Phase 1 trial • 32 Patients • NCT03276572
100%
Xerostomia
100%
Anemia
100%
Nausea
100%
Fatigue
100%
Anorexia
100%
Weight loss
100%
Pain
100%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
225Ac-J591 Cohort 1
225Ac-J591 Cohort 2
225Ac-J591 Cohort 3
225Ac-J591 Cohort 4
225Ac-J591 Cohort 5
225Ac-J591 Cohort 6
225Ac-J591 Cohort 7

Trial Design

1Treatment groups
Experimental Treatment
Group I: All SubjectsExperimental Treatment1 Intervention
A single dose of 225Ac-J591 will be given to subjects with documented progressive metastatic CRPC.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gallium Ga-68 gozetotide
FDA approved

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,093 Total Patients Enrolled
560 Trials studying Prostate Cancer
507,141 Patients Enrolled for Prostate Cancer
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,595 Total Patients Enrolled
28 Trials studying Prostate Cancer
6,925 Patients Enrolled for Prostate Cancer
Weill Medical College of Cornell UniversityLead Sponsor
1,054 Previous Clinical Trials
1,316,584 Total Patients Enrolled
48 Trials studying Prostate Cancer
35,607 Patients Enrolled for Prostate Cancer

Media Library

225Ac-J591 (Radioisotope Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03276572 — Phase 1
Prostate Cancer Research Study Groups: All Subjects
Prostate Cancer Clinical Trial 2023: 225Ac-J591 Highlights & Side Effects. Trial Name: NCT03276572 — Phase 1
225Ac-J591 (Radioisotope Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03276572 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA given clearance for 225Ac-J591 to be used in medical treatments?

"Our team at Power rated the safety of 225Ac-J591 with a score of 1 due to this being a Phase 1 trial, indicating there is sparse evidence supporting its efficacy and security."

Answered by AI

What is the target number of participants for this clinical experiment?

"Unfortunately, no more participants can be recruited for this trial at this time. Initially appearing on October 10th 2017 and most recently updated on March 2nd 2021, applicants are directed to other avenues of research; there are currently 1321 trials recruiting patients with prostate cancer and 12 clinical studies actively seeking 225Ac-J591 test subjects."

Answered by AI

Has 225Ac-J591 been the focus of any prior experiments?

"The develpoment of 225Ac-J591 began in 2016 at the Holden Comprehensive Cancer Center. Currently, 9 studies have concluded and 12 more are still ongoing - many within New Orleans, Louisiana."

Answered by AI

Are there still opportunities open to participants in this research?

"According to the clinicaltrials.gov platform, this particular trial is not actively seeking patients at the moment and was last modified on March 2nd 2021. Although there are 1,333 other studies that are currently accepting participants."

Answered by AI

What is the principal intent of this research?

"The primary endpoint of this clinical trial, which will be monitored over 100 months, is evaluating the occurrence of dose limiting toxicities (DLT). Additionally, researchers are also gathering data on overall survival after a single 225Ac-J591 dosage. Circulating tumor cells (CTC) response and patient reported outcomes (PRO) through Brief Pain Inventory score assessment have been identified as secondary objectives for evaluation."

Answered by AI

What afflictions is 225Ac-J591 typically deployed against?

"The radioimmunotherapy drug 225Ac-J591 is clinically employed to address tumor antigens, suspected metastasis, and positron emission tomography."

Answered by AI
~4 spots leftby Apr 2025