Comparing 177Lu-PSMA-617 and 225Ac-PSMA-617 for High-Risk Prostate Cancer
This study is comparing two treatments, 177 Lutetium Prostate-Specific Membrane Antigen 617 (177Lu-PSMA-617) and Actinium-225 Prostate-Specific Membrane Antigen 617 (225Ac-PSMA-617), for men with high-risk prostate cancer. Both treatments are given intravenously (into a vein) or intra-arterially (into an artery). Researchers want to see how much radiation dose each treatment delivers to the tumor and how they affect the body's immune cells. You may be able to join if you are an adult man with prostate cancer that is considered high-risk, and you are planning to have surgery to remove your prostate (prostatectomy). The study aims to understand which treatment is more effective at targeting the cancer. The current status of this study is unclear.
- Study design
- This is an interventional study planning to enroll 45 men. It is a pilot study comparing two different radioligand therapies.
- What's involved
- You would undergo a prostatectomy, have prostate tissue collected, and receive imaging procedures like SPECT/CT scans. The study measures tumor absorbed dose at 1 week and immune cell infiltration at 1 day and at the time of prostatectomy.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints are measured at 1 week and at 1 day/time of prostatectomy.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Comparison of 177Lu-PSMA-617 and 225Ac-PSMA-617
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Thomas A Hope, MD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
Who to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Mean of tumor absorbed dose (Cohorts 1 and 2)1 week
The mean tumor absorbed dose on post-treatment SPECT imaging within 7 days of the first radioligand treatment (RLT) will be obtained by using MIM Software to measure absorbed dose and researchers will manually segment activity in the dominant prostate tumor while carefully excluding any activity within the bladder using a threshold of 5 Gray. Using this segmented volume, the mean dose within the tumor in Gray for each participant and standard deviation will be calculated and reported descriptively for Cohorts 1 and 2. A two-sample t-test comparing the dose between Cohort 1 and Cohort 2 and Analysis of Variance (ANOVA) model to compare the dose between different treatment/fractionation modalities within each cohort will be performed.
- Rate of Cluster of differentiation 3 positive (CD3+) T cell infiltration1 day, at time of prostatectomy
Immunohistochemistry will be performed using standard methods, and stained slides will be scanned using an automated microscope scanner. Five randomly selected fields (0.25 mm\^2) from each participant's primary tumor will be captured. Using color-specific algorithms, CD3+ cell counts will be determined, and the mean of each of the five quantified fields will be used. We will use a two-sample t-test or ANOVA model comparing the CD3+ cell counts between Cohort 1 and Cohort 2 with participants who have not undergone prostatectomy enrolled in the biospecimen protocol, respectively.