Lu-177-PSMA-617 for Prostate Cancer

(ESCENDO Trial)

CA
Overseen ByCancer AnswerLine
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: University of Michigan Rogel Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

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?

KA

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

Platelet count ≥ 150,000/mm^3
Estimated glomerular filtration rate (EGFR) ≥ 60 ml/min
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3.0 x ULN or ≤ 5.0 x ULN for patients with liver metastases
See 10 more

Exclusion Criteria

Participation in other investigational trials during RLT or within 30 days prior to start of RLT
Diffuse marrow involvement evident on Ga-68-PSMA PET/CT as assessed by study treating clinician
Concurrent serious medical conditions including NYHA class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, active hepatitis B or C, or other significant co-morbidities impairing study participation
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Lu-177-PSMA-617 IV on day 1 of each cycle, with dose escalation in cycle 1 only

6 weeks per cycle, up to 30 weeks total
1 visit per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including SPECT/CT and PET/CT scans

12 weeks after last cycle

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

Group I: Dose Escalation (Lu-177-PSMA-617)Experimental Treatment8 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials
303
Recruited
20,700+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

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 ...

Lutetium 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 ...