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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the start of treatment to progression, up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the start of treatment to progression, up to 3 years
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 moreSide effects data
From 2023 Phase 1 trial • 32 Patients • NCT03276572100%
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
13,718 Previous Clinical Trials
40,963,359 Total Patients Enrolled
564 Trials studying Prostate Cancer
529,032 Patients Enrolled for Prostate Cancer
National Institutes of Health (NIH)NIH
2,720 Previous Clinical Trials
7,494,414 Total Patients Enrolled
28 Trials studying Prostate Cancer
6,925 Patients Enrolled for Prostate Cancer
Weill Medical College of Cornell UniversityLead Sponsor
1,060 Previous Clinical Trials
1,316,131 Total Patients Enrolled
48 Trials studying Prostate Cancer
34,579 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have active cancer that has spread to your brain or the tissues surrounding your brain.You have had a blood clot in your leg or lung within the past month.You have received treatment with at least one of the following in the past:You have a serious illness affecting your heart, lungs, brain, kidneys, liver, or blood that could make it difficult for you to complete the study or make it hard to determine if any side effects you experience are related to the study medication.You are currently taking a medication called enzalutamide, which is used to block the effects of the hormone testosterone.You are taking a medication called abiraterone acetate, which is a type of drug that inhibits CYP 17.You have another type of cancer, except for non-melanoma skin cancer. If you have completed treatment for your other cancer and your doctor thinks there is a low risk of it coming back (less than 30% chance), then you may still be eligible.
Research Study Groups:
This trial has the following groups:- Group 1: All Subjects
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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