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Radiopharmaceutical
Arm I (177Lu-PSMA-617) for Prostate Cancer
Phase 2
Waitlist Available
Led By Jeremie Calais
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have received at least one androgen-receptor signaling inhibitors (ARSI)
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the date of the first cycle of lu 177 vipivotide tetraxetan (177lu-prostate-specific membrane antigen [psma]-617) therapy, up to 2 years
Awards & highlights
Study Summary
This trial is testing a new treatment schedule for patients with advanced prostate cancer that has spread to other parts of the body. The current standard treatment involves 6 cycles of a therapy called 177Lu-pro
Who is the study for?
This trial is for individuals with metastatic castration-resistant prostate cancer, which continues to grow despite low testosterone levels from traditional hormone therapy. Participants should have PSMA receptors on tumor cells and be suitable for a flexible treatment schedule.Check my eligibility
What is being tested?
The study is testing a new dosing schedule of the drug 177Lu-PSMA-617 over 12 cycles versus the standard 6 cycles. It includes imaging techniques like PET scans and CTs to monitor progress, along with 'treatment holiday' periods.See study design
What are the potential side effects?
Possible side effects include radiation-related symptoms such as fatigue, nausea, dry mouth or changes in taste due to lutetium's attachment to tumor cells and its radioactive properties.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been treated with medication that targets hormone receptors.
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I am able to care for myself and up to being unable to work but can still move around.
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I am 18 years old or older.
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My prostate cancer diagnosis was confirmed through tissue examination.
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I have had chemotherapy for metastatic castration-resistant prostate cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the date of the first cycle of lu 177 vipivotide tetraxetan (177lu-prostate-specific membrane antigen [psma]-617) therapy, up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of the first cycle of lu 177 vipivotide tetraxetan (177lu-prostate-specific membrane antigen [psma]-617) therapy, up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
2-year survival rate
Secondary outcome measures
Bone pain level
DCR by combined radiographic + PSA response
Disease control rate (DCR)
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (177Lu-PSMA-617)Experimental Treatment7 Interventions
Patients receive 177Lu-PSMA-617 IV once every 6 weeks on study. Beginning with the third cycle, treatments may be postponed beyond the 6 weeks interval based on defined response criteria ("treatment holiday" period). Treatment repeats every 6 weeks for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients receive 68Ga-PSMA-11 IV and undergo PSMA PET/CT throughout the trial. Patients also undergo SPECT/CT, PET/CT, or CT on the trial.
Group II: Arm II (177Lu-PSMA-617)Active Control7 Interventions
Patients receive 177Lu-PSMA-617 IV once every 6 weeks on study. Treatment repeats every 6 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients receive 68Ga-PSMA-11 IV and undergo PSMA PET/CT throughout the trial. Patients also undergo SPECT/CT, PET/CT, or CT on the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PSMA PET Scan
2020
N/A
~10
Computed Tomography
2017
Completed Phase 2
~2720
Positron Emission Tomography
2008
Completed Phase 2
~2240
Single Photon Emission Computed Tomography
2008
Completed Phase 4
~310
Find a Location
Who is running the clinical trial?
Jonsson Comprehensive Cancer CenterLead Sponsor
361 Previous Clinical Trials
27,692 Total Patients Enrolled
38 Trials studying Prostate Cancer
3,892 Patients Enrolled for Prostate Cancer
Jeremie CalaisPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center
7 Previous Clinical Trials
1,283 Total Patients Enrolled
3 Trials studying Prostate Cancer
997 Patients Enrolled for Prostate Cancer
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants currently being actively recruited for this ongoing clinical trial?
"According to the information provided on clinicaltrials.gov, this particular trial is not actively seeking participants. The study was first posted on February 1st, 2024 and was last updated on January 10th, 2024. However, it's worth noting that there are currently 1315 other ongoing studies that are actively enrolling patients at this time."
Answered by AI
What are the potential risks associated with Arm I (177Lu-PSMA-617) in terms of human safety?
"Based on the classification of this trial as Phase 2, Arm I (177Lu-PSMA-617) is assigned a safety rating of 2. While there is some supporting data for safety, efficacy has not yet been demonstrated."
Answered by AI
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