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Radiopharmaceutical

225Ac-J591 for Prostate Cancer

Phase 1 & 2
Waitlist Available
Led By Scott Tagawa, MD MS
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 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 combination of two drugs, 225Ac-J591 and 177Lu-PSMA-I&T, to see if it is safe and effective in treating prostate cancer.

Eligible Conditions
  • Prostate Cancer

Timeline

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
Cumulative maximum tolerated dose (MTD) and recommended phase II dose 225Ac-J591 and 177Lu-PSMA I&T
Proportion of PSMA+ subjects (by imaging criteria) with PSA decline following treatment with the combination of 225Ac-J591 and 177Lu-PSMA I&T.
Proportion of subjects with dose limiting toxicity (DLT) of 225Ac-J591 and 177Lu-PSMA-I&T during dose-escalation phase.
Secondary outcome measures
Change in biochemical progression-free survival
Body Weight Changes
Change in disease assessment with 68Ga-PSMA-11 PET/CT prior to and following investigational treatment
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: All SubjectsExperimental Treatment3 Interventions
Patients enrolled in the study will receive the study drugs 225Ac-J591 and 177Lu-PSMA-I&T, along with 68Ga-PSMA-11.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
225Ac-J591
2017
Completed Phase 1
~40
Gallium Ga-68 gozetotide
FDA approved

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,054 Previous Clinical Trials
1,316,480 Total Patients Enrolled
48 Trials studying Prostate Cancer
35,591 Patients Enrolled for Prostate Cancer
POINT BiopharmaIndustry Sponsor
5 Previous Clinical Trials
566 Total Patients Enrolled
1 Trials studying Prostate Cancer
48 Patients Enrolled for Prostate Cancer
Scott Tagawa, MD MSPrincipal InvestigatorWeill Medical College of Cornell University

Frequently Asked Questions

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

Does this research study accept participants over the age of 18?

"The study necessitates that those seeking to participate are aged between 18 and 99. Additionally, there exist 76 trials for minors and 1350 studies catered specifically toward the elderly population."

Answered by AI

Are there current vacancies for participants in this research endeavor?

"This clinical trial is recruiting participants, with the initial posting dated June 30th 2021 and latest update on August 23rd 2022. Perusal of clinicaltrials.gov provides this information."

Answered by AI

For what health concerns is 177Lu-PSMA-I&T commonly prescribed?

"177Lu-PSMA-I&T is commonly employed to combat tumor antigens, as well as potentially diagnose suspected metastasis, positron emission tomography (PET) scans and prostate cancer."

Answered by AI

What is the current capacity of this clinical trial in terms of participant numbers?

"Affirmative. The clinicaltrials.gov database indicates that this study is presently seeking participants, with the original posting having occurred on June 30th 2021 and updated August 23rd 2022. This trial requires 33 patients from 2 sites to be enrolled."

Answered by AI

Has 177Lu-PSMA-I&T been the focus of prior research?

"Currently, there are 41 active clinical trials researching 177Lu-PSMA-I&T with 4 of the initiatives in Phase 3. Of these studies, several are based out of Melbourne, Victoria; however, a total of 252 medical centres globally have been tapped to host research for this drug."

Answered by AI

Who meets the criteria to be a participant in this medical experiment?

"This trial is seeking 33 participants with prostate cancer aged between 18-99. To be eligible, applicants must meet a series of stringent criteria including: having an absolute neutrophil count >2,000 cells/mm3; hemoglobin ≥9 g/dL; platelet count >150,000 x 109/uL and serum creatinine <1.5xULN or calculated creatinine clearance ≥60 mL/min/1.73 m2 by Cockcroft-Gault; histologically or cytologically confirmed adenocarcinoma of the prostate as well as documented progressive metastatic CRPC based on Pro"

Answered by AI

What is the purpose of this research?

"The primary purpose of this investigation over a period of 100 months is to measure the dose-limiting toxic effects caused by 225Ac-J591 and 177Lu-PSMA-I&T during dose escalation. Secondary objectives include monitoring biochemical progression, assessing treatment safety based on NCI CTCAE version 5.0 guidelines, and measuring overall survival rate."

Answered by AI
~8 spots leftby Dec 2024