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Escalating Cycle 1 Dose of Lu-177-PSMA-617 for the Treatment of Metastatic Castration Resistant Prostate Cancer

Study acronym: ESCENDO
StatusNot Yet Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Aug 2027 → Dec 2027
See other at-risk trials from University of Michigan Rogel Cancer Center

Record History

See every version on ClinicalTrials.gov ↗

  1. Start date: Aug 1, 2026 to Dec 1, 2026 Show 4 more changesShow less
    • Primary completion pushed from Aug 2027 to Dec 2027
    • Study completion pushed from Aug 2031 to Dec 2031
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints: details revised at 1 of 4 entries
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07682649
Lead Sponsor University of Michigan Rogel Cancer Center
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Metastatic Castration-Resistant Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8
Related terms Prostatic Neoplasms
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov