Last updated on July 2019

Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer

Brief description of study

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.

Detailed Study 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.

Clinical Study Identifier: NCT03511664

Find a site near you

Start Over

Tulane Cancer Center

New Orleans, LA United States
  Connect »

Mayo Clinic

Rochester, MN United States
  Connect »

Gettysburg Cancer Center

Gettysburg, PA United States
  Connect »

HonorHealth Institute

Scottsdale, AZ United States
  Connect »


Los Angeles, CA United States
  Connect »

Stanford University

Palo Alto, CA United States
  Connect »

UCSF Medical Center at Mission Bay

San Francisco, CA United States
  Connect »

Northwestern University

Chicago, IL United States
  Connect »

Parkview Cancer Institute

Fort Wayne, IN United States
  Connect »

Norton Cancer Institute

Louisville, KY United States
  Connect »

VA Ann Arbor Healthcare System

Ann Arbor, MI United States
  Connect »

Karmanos Cancer Center

Detroit, MI United States
  Connect »

St. Louis University Hospital

Saint Louis, MO United States
  Connect »

Regional Cancer Care Associates

East Brunswick, NJ United States
  Connect »

UVA Cancer Care

Charlottesville, VA United States
  Connect »

Center Jean Perrin

Clermont-Ferrand, France
  Connect »

St. Antonius Hospital

Nieuwegein, Netherlands
  Connect »

Guy's Hospital

London, United Kingdom
  Connect »

Iowa VA Medical Center

Iowa City, IA United States
  Connect »

Carolina Urologic Research Center

Myrtle Beach, SC United States
  Connect »

Swedish Cancer Institute

Seattle, WA United States
  Connect »