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Radioisotope Therapy
225Ac-J591 Re-treatment for Prostate Cancer
Phase < 1
Recruiting
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
Histologically or cytologically confirmed adenocarcinoma of prostate
Documented progressive metastatic CRPC based on Prostate Cancer Working Group 3 (PCWG3) criteria, which includes at least one of the following criteria: PSA progression, Objective radiographic progression in soft tissue, New bone lesions
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 if a re-treatment with a certain drug can be given without severe side effects.
Who is the study for?
Men over 18 with advanced prostate cancer that has spread and is resistant to hormone therapy can join. They must have had certain treatments like enzalutamide, abiraterone, or taxane chemotherapy. Good blood counts and organ function are required, and they should be able to perform daily activities with ease to moderate difficulty.Check my eligibility
What is being tested?
The trial tests if a second round of the drug 225Ac-J591 for metastatic castration-resistant prostate cancer (mCRPC) can be given safely without causing severe side effects. Participants will have already seen some benefit from this type of treatment before without major toxicities.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include typical reactions associated with radioisotope therapies such as nausea, fatigue, blood count changes leading to increased infection risk or bleeding tendencies, kidney damage or other organ-specific issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer was confirmed by a lab test.
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My prostate cancer is worsening, shown by rising PSA levels or new cancer spots on scans.
Select...
I am taking a medication like abiraterone acetate.
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 kidney function, measured by creatinine levels, is within the normal range.
Select...
I am older than 18 years.
Select...
I am taking medication that targets androgen receptors.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in the proportion of subjects in assessing safety of 225Ac-J591 in those previously treated with PSMA-TRT.
Secondary outcome measures
Change in Overall Survival Following re-Treatment Doses of 225Ac-J591
Change in adverse event rate response
Change in circulating tumor cells (CTC) response
+4 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
2Treatment groups
Experimental Treatment
Group I: Moderately ExposedExperimental Treatment1 Intervention
Group II: Heavily ExposedExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
225Ac-J591
2017
Completed Phase 1
~40
Find a Location
Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,055 Previous Clinical Trials
1,316,277 Total Patients Enrolled
48 Trials studying Prostate Cancer
35,621 Patients Enrolled for Prostate Cancer
Scott Tagawa, MDPrincipal InvestigatorWeill Medical College of Cornell University
7 Previous Clinical Trials
231 Total Patients Enrolled
6 Trials studying Prostate Cancer
211 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had a blood clot in my leg or lung within the last month.I have not had radiation therapy in the last 4 weeks.I have been diagnosed with myelodysplastic syndrome.I do not have serious heart, lung, brain, kidney, liver, or blood diseases that could affect my participation.My prostate cancer was confirmed by a lab test.I have had taxane chemotherapy, been told I can't have it, or refused it.My prostate cancer is worsening, shown by rising PSA levels or new cancer spots on scans.I am taking a medication like abiraterone acetate.My testosterone levels are below 50 ng/dL, and I am on hormone therapy or have had an orchiectomy.I have shown improvement with PSMA-TRT treatment without severe side effects.I have been treated with specific prostate cancer drugs or have been deemed ineligible for or refused taxane chemotherapy.Your PSA levels are increasing.You have had an experimental medical device implanted less than 4 weeks before the start of the study, or you are currently participating in a study involving an experimental drug or medical device for cancer.I can take care of myself and am up and about more than half of my waking hours.You have recently developed new bone abnormalities.I haven't used experimental drugs or been in a cancer study for at least 4 weeks.My kidney function, measured by creatinine levels, is within the normal range.I don't have an active cancer other than non-melanoma skin cancer, or it's under control with less than 30% risk of coming back.I am older than 18 years.I have had bone-targeting radiation treatment, but it's been over 12 weeks since my last dose.There is evidence of tumor growth seen on medical imaging tests.I am taking medication that targets androgen receptors.
Research Study Groups:
This trial has the following groups:- Group 1: Moderately Exposed
- Group 2: Heavily Exposed
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.
Will this research be limited to a certain age group?
"According to the eligibility standards for this clinical trial, any person aged 18 or above but not older than 99 can enroll in the program."
Answered by AI
What are the prerequisites for participating in this research?
"This prostate cancer study will have 18 participants that must meet the following requirements: new bone lesions, ECOG performance status of 0-2, taxane chemotherapy ineligibility (as determined by a physician), age > 18 years."
Answered by AI
Is this the first time 225Ac-J591 is being used in a trial?
"12 different clinical trials are currently underway to test the efficacy of 225Ac-J591. Out of these ongoing studies, 1 is in Phase 3 while the rest are in earlier stages. The majority of locations for these trials are situated Brooklyn, New york; however, there are a total of 16 centres running these tests."
Answered by AI
What indications does 225Ac-J591 commonly treat?
"Tumor antigens, metastasis, and positron emission tomography can all be effectively treated with 225Ac-J591."
Answered by AI
Are researchers looking for more participants in this experiment?
"That is accurate. The information available on clinicaltrials.gov reveals that this study began enrolling patients on 10/29/2020 and is still recruiting today. They are hoping to have 18 people total from 2 different locations participate in the trial."
Answered by AI
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