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Radioisotope Therapy
177Lu-PSMA-I&T for Prostate Cancer
Phase 3
Waitlist Available
Research Sponsored by Curium US LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Progressive disease by one or more of the following criteria: Serum/plasma PSA progression, Progression of measurable disease or presence of at least two new bone lesions
Effective castration with serum testosterone level of <50 ng/dL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 156 weeks
Awards & highlights
Study Summary
This trial is comparing the safety and efficacy of 177Lu-PSMA-I&T (a treatment for prostate cancer) to hormone therapy.
Who is the study for?
Men over 18 with advanced prostate cancer that's resistant to hormone therapy can join. They must have tried and progressed on treatments like abiraterone or enzalutamide, but not more than one type. A positive PSMA-PET scan is needed, and they should be effectively castrated with low testosterone levels. HIV or hepatitis B/C patients may qualify if well-managed. Participants need a life expectancy of at least 6 months and agree to use contraception.Check my eligibility
What is being tested?
This study compares the safety and effectiveness of a new treatment called 177Lu-PSMA-I&T against standard hormone therapies (abiraterone with prednisone or enzalutamide) in men whose prostate cancer has spread despite castration. It's an open-label trial where everyone knows which treatment they're getting, and it randomly assigns participants to either group.See study design
What are the potential side effects?
Possible side effects for the new treatment include nausea, fatigue, dry mouth, changes in blood counts leading to increased risk of infection or bleeding, kidney damage, and temporary pain flare-ups in areas where cancer has spread.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has worsened, shown by rising PSA levels, growth of tumors, or new bone lesions.
Select...
My testosterone levels are below 50 ng/dL due to treatment.
Select...
I have received ARAT for my cancer and it has progressed despite the treatment.
Select...
My prostate cancer is confirmed without a major small cell component.
Select...
I am willing to start ARAT therapy.
Select...
I have been treated with advanced hormone therapy for cancer.
Select...
I have had only one previous hormone therapy for cancer.
Select...
I am a man over 18 and can sign a consent form.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 156 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~156 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Radiographic Progression Free Survival
Secondary outcome measures
Overall Survival (OS)
PSA50 Response Rate
Progression Free Survival
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Investigational DrugExperimental Treatment1 Intervention
177Lu-PSMA-I&T
Group II: Standard Of Care Hormone TherapyActive Control1 Intervention
Abiraterone with Prednisone or Enzalutamide
Find a Location
Who is running the clinical trial?
Curium US LLCLead Sponsor
4 Previous Clinical Trials
552 Total Patients Enrolled
2 Trials studying Prostate Cancer
523 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My physical functioning is somewhat limited.My cancer has worsened, shown by rising PSA levels, growth of tumors, or new bone lesions.You have a serum/plasma PSA level of 2 ng/mL or greater.I am a man over 18 and can sign a consent form.I have had chemotherapy for prostate cancer that did not respond to hormone therapy, with some exceptions.My hepatitis B or C symptoms are under control.My prostate cancer is confirmed without a major small cell component.I have an HRR gene mutation and haven't been treated with olaparib or rucaparib.My organ and bone marrow functions are not meeting certain health standards.I do not currently have active Covid-19 but have fully recovered if I had it.My testosterone levels are below 50 ng/dL due to treatment.I am not currently receiving any other cancer treatments.I have been on a stable dose of zoledronic acid for bone therapy for at least 4 weeks.I have received ARAT for my cancer and it has progressed despite the treatment.I have been treated with ARAT for prostate cancer.My cancer has worsened, shown by rising PSA levels, growth of tumors, or new bone lesions.My PSMA-PET scan shows positive results.I have cancer, but it's not low-grade bladder cancer or non-melanoma skin cancer.My prostate cancer is confirmed without a major small cell component.I have not had radium-223 treatment in the last 3 months.I haven't used any experimental drugs in the last 4 weeks.I am willing to start ARAT therapy.I have been treated with advanced hormone therapy for cancer.I have a serious heart condition.I have had only one previous hormone therapy for cancer.I have used G-CSF for ongoing low white blood cell count after standard treatment.I am a man over 18 and can sign a consent form.I can attend all necessary study visits and follow-up appointments.I have previously received treatment with radioligand therapy.I have symptoms or signs of potential spinal cord compression.I have brain metastases but am stable and symptom-free after treatment.I have not had major surgery in the last 30 days.My testosterone levels are low due to treatment, and I plan to continue this treatment.I have been treated with advanced hormone therapies for cancer.My cancer has grown or spread to my bones.
Research Study Groups:
This trial has the following groups:- Group 1: Standard Of Care Hormone Therapy
- Group 2: Investigational Drug
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Prostate Cancer Patient Testimony for trial: Trial Name: NCT05204927 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new patients being accepted into this research project?
"That is correct, the clinical trial detailed on clinicaltrials.gov is ongoing and looking for 400 patients at 31 different locations. The first posting was on 2/14/2022 with the most recent update being 11/3/2022."
Answered by AI
Are there different locations in the United States where this clinical trial is being conducted?
"Currently, this trial is being conducted in 31 different locations. These sites include those situated in Grand Rapids, Miami and Tampa as well as other places. If you are interested in participating, please select the site nearest to your location to minimize required travel."
Answered by AI
How many patients are participating in this trial?
"Curium US LLC, the sponsor of this research, needs 400 individuals that fit the clinical trial's inclusion criteria in order to begin. The study will be conducted at BAMF Health I PC in Grand Rapids, Michigan and Biogenix Molecular LLC in Miami, Florida."
Answered by AI
What are the potential risks associated with Lu-177-PSMA-I&T?
"Lu-177-PSMA-I&T is in Phase 3 clinical trials, meaning that while there is some evidence of efficacy, multiple rounds of testing have shown it to be safe."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
M Health Fairview Ridges Cancer Clinic
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Diagnosed with very high risk, locally advanced high grade prostate cancer (Gleason Score 9). Currently on ADT. Starting 5-1/2 weeks of EBT on December 28.
PatientReceived no prior treatments
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