Lu-177-PSMA-617 for Prostate Cancer
(ESCENDO Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the safety and optimal initial dose of Lu-177-PSMA-617, a radioactive drug, for prostate cancer that resists standard hormone therapy and has metastasized. The treatment uses this radioactive drug to target and potentially kill cancer cells. Researchers aim to determine if a higher dose in the first treatment cycle proves more effective. Men with prostate cancer that continues to grow despite low hormone levels and who have cancer spots visible on a specific type of scan might be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.
Is there any evidence suggesting that Lu-177-PSMA-617 is likely to be safe for humans?
Research has shown that Lutetium Lu 177 vipivotide tetraxetan is generally safe for people with prostate cancer. Studies have found it can help extend life and slow cancer growth. In previous studies, most participants tolerated the treatment well. However, some experienced side effects such as lower blood counts and dry mouth, which were usually manageable. The FDA has approved the treatment for certain types of prostate cancer, indicating a well-understood safety profile.12345
Why do researchers think this study treatment might be promising?
Unlike the standard treatments for prostate cancer, which typically include hormone therapy, surgery, and chemotherapy, Lu-177-PSMA-617 offers a more targeted approach. This treatment uses a radioactive particle, Lutetium-177, which is linked to a molecule that specifically targets prostate-specific membrane antigen (PSMA) present on prostate cancer cells. By directly delivering radiation to the cancer cells, it aims to minimize damage to healthy tissues and enhance treatment precision. Researchers are excited because this method could offer a more effective and less toxic alternative to existing therapies, potentially improving outcomes for patients with advanced prostate cancer.
What evidence suggests that Lu-177-PSMA-617 might be an effective treatment for prostate cancer?
Research has shown that Lu-177-PSMA-617 holds promise for treating prostate cancer, particularly when the cancer has spread and resists hormone therapy. This trial will explore various dosing levels of Lu-177-PSMA-617, which targets a protein called PSMA on prostate cancer cells. Upon attachment, it releases radiation directly to the cancer cells, aiding in their destruction. Early results suggest that the initial dose in a series might be most effective at delivering radiation to the cancer. Studies indicate that this targeted approach may improve outcomes for patients with advanced prostate cancer that resists other treatments.678910
Who Is on the Research Team?
Kirk A Frey, MD
Principal Investigator
University of Michigan Rogel Cancer Center
Are You a Good Fit for This Trial?
This trial is for men with prostate cancer that has spread to other parts of the body and keeps growing even when testosterone levels are very low (castration-resistant).Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Lu-177-PSMA-617 IV on day 1 of each cycle, with dose escalation in cycle 1 only
Follow-up
Participants are monitored for safety and effectiveness after treatment, including SPECT/CT and PET/CT scans
What Are the Treatments Tested in This Trial?
Interventions
- Lutetium Lu 177 Vipivotide Tetraxetan
Trial Overview
Researchers are testing if giving a higher dose of Lu-177-PSMA-617, a radioactive drug targeting prostate cancer cells, in the first treatment cycle is safe and more effective than standard dosing. The total amount given over time stays the same.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients receive Lu-177-PSMA-617 IV on day 1 of each cycle. Dose escalation will occur in cycle 1 only: Level 1: 14.8 GBq (7.4 GBq administered 2 times, 2 days apart) Level 2: 22.2 GBq (7.4 GBq administered 3 times, each 2 days apart) Cycles repeat every 6 weeks for up to 5 cycles for dose level 1 and up to 4 cycles for dose level 2, with the Lu-177-PSMA-617 dose of 7.4 GBq, in the absence of disease progression or unacceptable toxicity. Patients also undergo SPECT/CT scans and receive Ga-68 PSMA-11 and undergo PET/CT after cycle 1.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Michigan Rogel Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
Prostate Anatomy
The more you know about the normal development and function of the prostate, where it's located, and what it's attached to, the better you can understand.
Prostate: Anatomy, Location, Function & Conditions
The prostate is a gland below your bladder, in front of your rectum. It adds fluids to your semen and helps semen exit your body. Cancer and BPH may affect ...
In brief: How does the prostate work? - InformedHealth.org
Our information is based on the results of good-quality studies. It is written by a team of health care professionals, scientists and ...
Prostate cancer - Symptoms and causes
Treatments are most effective when the cancer is caught early. In fact, immediate treatment isn't always necessary. Keeping an eye on the cancer ...
Prostate
The prostate is an accessory gland of the male reproductive system and a muscle-driven mechanical switch between urination and ejaculation.
FDA approves lutetium Lu 177 vipivotide tetraxetan with ...
The trial demonstrated a statistically significant improvement in rPFS in patients treated with lutetium Lu 177 vipivotide tetraxetan and an ...
Impact of lutetium Lu 177 vipivotide tetraxetan on prostate ...
Results: Among 62 patients, 27 (43.6%) were Black or African American and 35 (56.5%) were White (Table). A ≥50% decline in prostate-specific ...
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 ...
Lutetium 177Lu Vipivotide Tetraxetan Efficacy and Toxicity ...
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 ...
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onclive.com
onclive.com/view/lutetium-lu-177-vipivotide-tetraxetan-approval-reshapes-the-treatment-landscape-for-psma-mhspcLutetium Lu 177 Vipivotide Tetraxetan Approval Reshapes ...
Findings from an updated analysis showed that the lutetium Lu 177 vipivotide tetraxetan regimen further reduced the risk of progression or death ...
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