← Back to Search

Radioisotope Therapy

225Ac-J591 for Prostate Cancer

Phase 1 & 2

Recruiting

Led By Joseph R Osborne, 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

Patients must have normal organ and marrow function as defined below: Absolute neutrophil count >2,000 cells/mm3, Hemoglobin ≥9 g/dL, Platelet count >150,000 x 109/uL, Serum creatinine <1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60 mL/min/1.73 m2 by Cockcroft-Gault, Serum total bilirubin <1.5 x ULN (unless due to Gilbert's Syndrome in which case direct bilirubin must be normal), Serum AST and ALT <3 x ULN in absence of liver metastases; < 5x ULN if due to liver metastases(in both circumstances bilirubin must meet entry criteria), Ability to understand and the willingness to sign a written informed consent document

Age > 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up will be collected at the time of visit 1 through end of study or 100 months

Awards & highlights

Study Summary

This trial is testing a new drug to see what dose is safe for humans and how it should be given.

Who is the study for?

This trial is for adults over 18 with advanced prostate cancer that's getting worse despite treatment. They need to have good physical function and normal blood, kidney, and liver tests. They must have had hormone therapy and chemotherapy or be ineligible/refused chemo. People can't join if they've used certain investigational drugs recently, have serious illnesses, brain metastases, recent clots, started bone treatments within 4 weeks of the study start or are unwilling to use birth control.Check my eligibility

What is being tested?

The trial is testing a drug called 225Ac-J591 for progressive metastatic castration-resistant prostate cancer (mCRPC). Initially, it aims to find a safe dose level and schedule (phase I), followed by assessing how well it works in reducing PSA levels by more than half in patients with PSMA-positive tumors (phase II).See study design

What are the potential side effects?

Possible side effects include reactions related to organ inflammation due to radiation exposure from the drug being tested. Since this is an early-phase trial determining safety, specific side effect profiles will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am older than 18 years.

Select...

My testosterone levels are below 50 ng/dL, and I am on hormone therapy or have had an orchiectomy.

Select...

I can take care of myself and am up and about more than half of my waking hours.

Select...

My prostate cancer is worsening, shown by rising PSA levels or new cancer spots on scans.

Select...

My prostate cancer was confirmed by a lab test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ will be collected at the time of visit 1 through end of study or 100 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~will be collected at the time of visit 1 through end of study or 100 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and will be collected at the time of visit 1 through end of study or 100 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assess the proportion of those with PSMA+ tumors with >50% PSA decline following 225Ac-J591 in two regimens (phase II)

Assess the recommended phase II dose (RP2D) of 225Ac-J591 in fractionated dose and multiple dose regimens (phase I)

Cumulative maximum tolerated dose (MTD)

+1 more

Secondary outcome measures

Assess biochemical progression-free survival

Assess the proportion with different levels of PSA decline following 225Ac-J591

Change in circulating tumor cells (CTC) and the rate of favorable and undetectable CTC count at 12 weeks following 225Ac-J591

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Multiple Dose CohortExperimental Treatment2 Interventions

Patients will receive 225Ac-J591 every 6 weeks, with up to 4 doses. Some patients will be enrolled in a dose-escalation design, with up to 3 dosing cohorts. Additional patients will be enrolled at 2 lower dosing-cohorts.

Group II: Dose- Fractionated CohortExperimental Treatment2 Interventions

Patients will receive a single cycle of 225Ac-J591, administered as a fractionated dose on days 1 and 15. This is a dose-escalation design, with up to 4 dosing cohorts.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

225Ac-J591

2017

Completed Phase 1

~40

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor

1,054 Previous Clinical Trials

1,316,423 Total Patients Enrolled

48 Trials studying Prostate Cancer

35,534 Patients Enrolled for Prostate Cancer

Joseph R Osborne, MDPrincipal InvestigatorWeill Medical College of Cornell University

Scott Tagawa, MDPrincipal InvestigatorWeill Medical College of Cornell University

7 Previous Clinical Trials

144 Total Patients Enrolled

6 Trials studying Prostate Cancer

124 Patients Enrolled for Prostate Cancer

Media Library

225Ac-J591 (Radioisotope Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04506567 — Phase 1 & 2

Prostate Cancer Research Study Groups: Multiple Dose Cohort, Dose- Fractionated Cohort

Prostate Cancer Clinical Trial 2023: 225Ac-J591 Highlights & Side Effects. Trial Name: NCT04506567 — Phase 1 & 2

225Ac-J591 (Radioisotope Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04506567 — Phase 1 & 2

Frequently Asked Questions

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

How many people are receiving care as part of this research project?

"Yes, this is an ongoing recruiting trial according to the latest update on clinicaltrials.gov from 11/23/2020. The study was first posted on 8/18/2020 and is looking for 105 patients at 2 locations."

Answered by AI

How can I become a participant in this clinical trial?

"Prostate cancer patients that wish to enroll in this study must be between 18 and 99 years old. Currently, the trial is looking for 105 total participants."

Answered by AI

Does this study require that participants be above a certain age?

"This trial is for patients aged 18 to 99. For context, there are 80 clinical trials underway for individuals younger than this age bracket and 1360 studies recruiting seniors that are 65 years or older."

Answered by AI

Does this experiment have any open positions for participants?

"The latest information from clinicaltrials.gov suggests that this particular trial is still recruiting patients. The original posting date was 8/18/2020, with the most recent update on 11/23/2020."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Fractionated and Multiple Dose 225Ac-J591 for Progressive mCRPC

2020. "Fractionated and Multiple Dose 225Ac-J591 for Progressive mCRPC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04506567.

All > Prostate Cancer New York