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Radioisotope Therapy
Ac225-PSMA I&T for Prostate Cancer (TATCIST Trial)
Phase 2
Recruiting
Led By Rodolfo Nunez, MD
Research Sponsored by Fusion Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Received ≥ 1 androgen receptor axis-targeted therapies (ARAT)
Adenocarcinoma of prostate proven by histopathology
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of treatment until 12 weeks after the first treatment.
Awards & highlights
TATCIST Trial Summary
This trial will use 4 doses of a new cancer treatment called 225Ac-PSMA-I&T.
Who is the study for?
This trial is for men with advanced prostate cancer that can't be removed, has spread, and isn't responding to certain therapies like docetaxel. Participants must understand the study, sign consent, have a life expectancy of at least 6 months, and meet specific health criteria including blood counts and organ function tests.Check my eligibility
What is being tested?
The TATCIST trial is testing a treatment called Ac225-PSMA I&T in men with castration-resistant prostate cancer. It involves four doses of this targeted alpha therapy which seeks out cancer cells using a molecule that binds to PSMA receptors on tumor cells.See study design
What are the potential side effects?
Potential side effects may include risks associated with radiation such as bone marrow suppression (low blood cell counts), kidney damage or dryness in mouth/eyes from previous treatments. Specific side effects of Ac225-PSMA I&T are not listed but would likely relate to its mechanism of action.
TATCIST Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have received at least one therapy targeting the androgen receptor.
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My prostate cancer was confirmed through tissue examination.
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My cancer has spread and cannot be removed with surgery.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My liver is working within normal ranges.
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My prostate cancer is worsening despite treatment.
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I have a BRCA mutation and have been treated with FDA-approved therapies.
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My prostate cancer is not responding to hormone therapy, with testosterone levels ≤ 50 ng/dL.
TATCIST Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from start of treatment until 12 weeks after the first treatment.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of treatment until 12 weeks after the first treatment.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To evaluate the effect of FPI-2265 on prostate-specific antigen (PSA) in participants with mCRPC.
Secondary outcome measures
To assess the impact of FPI-2265 on participant reported outcomes.
To evaluate the anti-tumor activity of FPI-2265.
To evaluate the safety and tolerability of FPI- 2265.
TATCIST Trial Design
1Treatment groups
Experimental Treatment
Group I: FPI-2265Experimental Treatment1 Intervention
All patients will receive FPI-2265, administered at 8 ± 1-week interval, with the initial activity of 100 kBq/kg (±10%).
Find a Location
Who is running the clinical trial?
Fusion Pharmaceuticals Inc.Lead Sponsor
4 Previous Clinical Trials
411 Total Patients Enrolled
Excel Diagnostics and Nuclear Oncology CenterLead Sponsor
5 Previous Clinical Trials
548 Total Patients Enrolled
1 Trials studying Prostate Cancer
208 Patients Enrolled for Prostate Cancer
Keith BarnettStudy DirectorFusion Pharmaceuticals Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function and blood tests are not within normal ranges.I have received at least one therapy targeting the androgen receptor.I am 18 years old or older.I am experiencing symptoms due to spinal cord pressure.My prostate cancer was confirmed through tissue examination.My cancer has spread and cannot be removed with surgery.I am fully active or restricted in physically strenuous activity but can do light work.I am currently on anti-androgen therapy and can continue it.My liver is working within normal ranges.My prostate cancer is worsening despite treatment.I have long-term dry eyes or mouth from previous therapy.I can understand and sign the consent form.I have a blockage in my urinary tract confirmed by a scan.I have a BRCA mutation and have been treated with FDA-approved therapies.I have cancer, but it's not one of the few exceptions listed.I have had more than 4 treatments for prostate cancer after it spread.It has been less than 6 weeks since my last treatment that lowers my blood cell counts.I have not had major surgery in the last 30 days.My bone scan shows widespread cancer spread in my bones.My prostate cancer is not responding to hormone therapy, with testosterone levels ≤ 50 ng/dL.I have lasting side effects from cancer treatment that are mild.My cancer has spread to my brain or liver.I understand and can follow all study instructions.
Research Study Groups:
This trial has the following groups:- Group 1: FPI-2265
Awards:
This trial has 1 awards, including:- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you elaborate on the potential risks of Ac225-PSMA I&T?
"Ac225-PSMA I&T is a Phase 2 clinical trial medication, meaning that while there is some data indicating it is safe, there is no evidence yet of the drug's efficacy."
Answered by AI
Are there any available slots for patients who want to participate in this clinical trial?
"That is correct, the listing on clinicaltrials.gov does show that this trial is looking for participants. According to the posting, which was last updated on 1/27/2022, they are hoping to find 100 individuals from a single site."
Answered by AI
How many people are being approved to participate in this research?
"That is correct, the online information from clinicaltrials.gov affirms that this study is looking for more participants. The original posting was on December 16th 2021 with the most recent update happening January 27th of this year. They are hoping to find 100 individuals total from various locations."
Answered by AI
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