Lutetium 177Lu PSMA RLT for Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if adjusting the timing of doses for lutetium 177 Lu PSMA RLT, a prostate cancer treatment and type of radioligand therapy, can improve quality of life without affecting lifespan. This treatment targets prostate cancer cells that resist hormone therapy and may have spread. Participants will receive either the standard treatment schedule or an adaptive schedule that changes based on disease activity. Men with hormone-resistant prostate cancer that has spread and who have experienced progression despite prior treatments might be good candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in prostate cancer treatment.
Do I need to stop taking my current medications for the trial?
Yes, you will need to stop taking any androgen receptor pathway inhibitors (like apalutamide, darolutamide, enzalutamide, or abiraterone) at least 4 weeks before joining the trial. Other systemic anti-cancer therapies must also be stopped 28 days before pre-registration.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that lutetium Lu 177 vipivotide tetraxetan is generally well-tolerated by patients with prostate cancer. A small initial study found this treatment effective for patients whose cancer cells have a protein called PSMA, which the drug targets. Other studies report a significant reduction in disease progression and a 59% lower risk of death.
The treatment also shows positive results in real-world use, consistent with findings from larger studies. The FDA has approved it for certain prostate cancer cases, indicating a good safety profile. While side effects can occur, they are usually manageable. Overall, evidence suggests that lutetium Lu 177 vipivotide tetraxetan is a promising and safe option for treating prostate cancer.12345Why are researchers excited about this trial's treatment?
Researchers are excited about Lutetium Lu 177 Vipivotide Tetraxetan for prostate cancer because it offers a targeted approach by using a radioactive particle that specifically binds to PSMA, a protein commonly found on prostate cancer cells. Unlike traditional chemotherapy, which can affect healthy cells, this treatment aims to deliver radiation directly to the cancer cells, potentially reducing side effects. Additionally, the study explores both standard and adaptive dosing strategies, which could optimize treatment effectiveness and personalize care for patients based on their individual response, something not typically seen in current treatments like hormone therapy and chemotherapy.
What evidence suggests that this trial's treatments could be effective for prostate cancer?
Research has shown that lutetium 177 Lu PSMA RLT effectively treats advanced prostate cancer. Studies have found that it can reduce the risk of death by 38% and slow disease progression by 60%. Many patients experience a decrease in PSA levels, indicating reduced prostate cancer activity. Specifically, 68.9% of patients see a drop of 10% or more, and 55.6% see a reduction of 50% or more. This treatment also extends patient survival, with some studies reporting an average survival time of 15.3 months. The therapy targets and destroys cancer cells with the PSMA protein, commonly found in prostate cancer cells. Participants in this trial will receive lutetium 177 Lu PSMA RLT in various dosing regimens, including standard and adaptive dosing, to assess its effectiveness and safety.36789
Who Is on the Research Team?
Thomas Hope, MD
Principal Investigator
Alliance for Clinical Trials in Oncology
Are You a Good Fit for This Trial?
This trial is for people with advanced prostate cancer that no longer responds to hormone therapy and has spread beyond the prostate. Participants must have tried at least one hormone-blocking drug, show signs of disease progression, have a positive PSMA PET scan, and not have had certain types of chemotherapy recently.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Screening
Participants are screened for eligibility to participate in the trial
Pre-registration Step 0
Patients receive 177Lu PSMA RLT IV on day 1 of each cycle. Cycles repeat every 6 weeks for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
Pre-registration Step 0
Patients receive 177Lu PSMA RLT IV on day 1 of each cycle. Cycles repeat every 6 weeks for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
Randomization Step 1
Patients are randomized to either standard or adaptive dosing. Standard dosing involves 177Lu PSMA RLT IV every 6 weeks for up to 4 cycles. Adaptive dosing involves PSA monitoring every 3 weeks with treatment based on PSA levels.
Randomization Step 1
Patients are randomized to either standard or adaptive dosing. Standard dosing involves receiving 177Lu PSMA RLT IV every 6 weeks for up to 4 cycles. Adaptive dosing involves PSA monitoring every 3 weeks and treatment based on PSA levels.
Follow-up
Participants are monitored for safety and effectiveness after treatment. Follow-up occurs every 12 weeks until disease progression and then every 6 months thereafter for 5 years.
Follow-up
Participants are monitored for safety and effectiveness after treatment. Follow-up occurs every 12 weeks until disease progression and then every 6 months thereafter for 5 years.
What Are the Treatments Tested in This Trial?
Interventions
- Lutetium Lu 177 Vipivotide Tetraxetan
Trial Overview
The study compares two ways of giving Lutetium 177Lu PSMA RLT: the standard schedule (every 6 weeks) versus an adaptive schedule where later doses are delayed until there are signs the cancer is active again. The goal is to see if delaying treatment can improve quality of life without shortening lifespan.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Starting cycle 2 day 42, patients undergo blood sample collection and PSA monitoring Q3W in the absence of disease progression or unacceptable toxicity. Patients with either an absolute PSA rise \> 4 ng/dL, PSA rise \> 25% above nadir, or clinical progression receive 177Lu PSMA RLT IV three weeks later. Patients then resume PSA monitoring Q3W with adaptive 177Lu PSMA RLT dosing as above for up to 4 total doses in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, CT, and bone scan throughout the trial and PSMA PET during screening. Patients with a history of brain metastases or with clinical indication also undergo MRI throughout the trial.
Patients receive 177Lu PSMA RLT IV on day 1 of each cycle. Cycles repeat every 6 weeks for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve a PSA50 response at C2 D22 proceed to Step 1. Additionally, patients undergo blood sample collection, CT, and bone scan throughout the trial and PSMA PET during screening. Patients with a history of brain metastases or with clinical indication also undergo MRI throughout the trial.
Patients receive 177Lu PSMA RLT IV on day 1 of each cycle. Cycles repeat every 6 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, CT, and bone scan throughout the trial and PSMA PET during screening. Patients with a history of brain metastases or with clinical indication also undergo MRI throughout the trial
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alliance for Clinical Trials in Oncology
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
Efficacy, toxicity, and clinical outcomes of 177Lu-PSMA-617 ...
177Lu-PSMA-617 at 5.5 GBq per cycle was safe and effective, achieving survival comparable to studies using 7.4 GBq with fewer severe toxicities.
[177Lu]Lu-PSMA-617 (PluvictoTM): The First FDA- ...
[177Lu]Lu-PSMA-617 in combination with the standard therapy reduced the overall mortality by 38% and disease progression by 60% [1].
The therapeutic use of 177 Lu-PSMA-617 radioligand therapy ...
This review highlights the promising advancements of 177Lu-PSMA-617 radioligand therapy, demonstrating its efficacy in treating progressive ...
4.
journals.lww.com
journals.lww.com/ajandrology/fulltext/9900/177lu_psma_for_prostate_cancer__progress,.388.aspx177 Lu-PSMA for prostate cancer: progress, challenges ...
The results demonstrated that 177Lu-PSMA-617 combined with standard therapy significantly improved the rPFS (median: 8.7 months vs 3.4 months) and OS (median: ...
Lutetium 177Lu Vipivotide Tetraxetan Efficacy and Toxicity in ...
A total of 68.9% of the cohort observed PSA biomarker improvement of ≥10%, and 55.6% with ≥50% PSA reduction. Three patients (6.7%) achieved a ...
Lutetium Lu 177 Vipivotide Tetraxetan: First Approval - PMC
A pilot study (NCT03828838) showed that treatment with lutetium Lu 177 vipivotide tetraxetan was effective in patients with PSMA-expressing, low volume (≥ 1 ...
7.
cancer.gov
cancer.gov/research/participate/clinical-trials/intervention/lutetium-lu-177-vipivotide-tetraxetan?pn=1Clinical Trials Using Lutetium Lu 177 Vipivotide Tetraxetan
Testing Different Dosing Schedules of the Anti-cancer Drug, Lutetium 177Lu PSMA RLT and its Effect on Patients with Advanced Prostate Cancer, RECIPROCAL Trial.
Real world outcomes in patients with metastatic castration ...
Conclusions: Lu177-PVT is a promising treatment for mCRPC in patients. Our results confirm 'real-world' activity of Lu177-PVT and align well with VISION study ...
FDA approves earlier use of lutetium Lu 177 vipivotide ...
lutetium Lu 177 vipivotide tetraxetan significantly reduces the risk of disease progression or death by 59%. The treatment
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