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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 phase I trial studies the safety, side effects, and treatment cycle 1 best dose of Lu-177-PSMA-617 in patients with prostate cancer that keeps growing even when the amount of testosterone in the body is reduced to very low levels (castration-resistant) and has spread from where it first started (primary site) to other places in the body (metastatic). Lu-177-PSMA-617 is a radioactive drug. It binds to a protein called prostate-specific membrane antigen (PSMA), which is found on prostate cancer tumor cells. Lu-177-PSMA-617 gives off radiation that may kill these tumor cells. It is a type of radioconjugate. Lu-177-PSMA-617 is currently used in a series of 6 intravenous infusions of the standard dosage, each separated by 6 weeks from the previous infusion. Investigators have observed that the first therapy administration (cycle 1) delivers better radiation treatment to the cancer than each of the following 5 infusions. Giving an increased dosage of Lu-177-PSMA-617 in treatment cycle 1 may have a better effect on metastatic castration-resistant prostate cancer than the standard dosage. The study does not change the total cumulative activity from what is used in the standard dosage treatment but gives an increased dosage in cycle 1 and reduces the total number of cycles.

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
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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+

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