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Clinical Trial Summary

The primary objective of this study is to compare overall survival (OS) in patients with progressive PSMA-positive mCRPC who receive 177Lu-PSMA-617 in addition to best supportive/best standard of care versus patients treated with best supportive/best standard of care alone.

Key secondary objectives are an arm-to-arm comparison of the following:

- Radiographic progression-free survival (rPFS)

- Response Evaluation Criteria in Solid Tumors (RECIST) response

- Time to a first symptomatic skeletal event (SSE)

Additional Secondary Objectives:

- Safety and tolerability of 177Lu-PSMA-617

- Health-related quality of life (HRQoL; EQ-5D-5L, FACT-P and Brief Pain Inventory - Short Form (BPI-SF))

- Health economics

- Progression-free survival (PFS) (radiographic, clinical, or prostate-specific antigen [PSA] progression-free survival)

- Biochemical response as measured by PSA. Alkaline phosphatase [ALP] levels and lactate dehydrogenase [LDH] levels will also be measured.


Clinical Trial Description

Patients with PSMA positive scans will be randomized in a 2:1 ratio to receive either 177Lu-PSMA-617 plus best supportive/best standard of care or to receive best supportive/best standard of care only. Best supportive/best standard of care will be determined by the treating physician/investigator but will exclude investigational agents, cytotoxic chemotherapy, other systemic radioisotopes, and hemi-body radiotherapy. Novel androgen axis drugs [NAADs] (such as abiraterone or enzalutamide) are allowed.

The study is open-label and patients will be monitored throughout the 6 to 10-month treatment period for survival, disease progression, and adverse events.

A long-term follow-up period will include the collection of survival and treatment updates, adverse events assessment, as well as blood for hematology and chemistry testing. During follow-up, patients will be contacted every 3 months (±1 month) via phone, email, or letter for 24 months or until the the overall censoring rate for survival reduces to a level identified in the SAP.

An End of Treatment visit should occur once a patient is to enter the long term follow up. This visit should occur approximately 30 days from the last dose of 177Lu-PSMA-617 or best supportive/best standard of care, but before the initiation of subsequent anti-cancer treatment, outside of what is allowed on study.

The planned enrollment for this study is 750 patients. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03511664
Study type Interventional
Source Endocyte
Contact Richard Messmann, MD
Phone 517-376-2006
Email rmessmann@endocyte.com
Status Recruiting
Phase Phase 3
Start date May 23, 2018
Completion date May 2021

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