US-based, Phase II trial of lutetium-177 PSMA-directed endoradiotherapy

We have been provided (by the developers) with additional information about a US-based, Phase II, clinical trial of a form of radiation therapy using the targeted agent lutetium-177 prostate-specific membrane antigen 617 (177Lu-PSMA-617) for treatment of men with metastatic, castration-resistant prostate cancer (mCRPC).

We had last published commentary on the development of this agent in October 2016.

Information about this clinical trial is available on the web site. The investigators are seeking to enroll 200 patients to conduct an initial assessment of the safety and efficacy of this particular form of 177Lu-PSMA here in the US. Available published data have suggested that this form of treatment is active in men with mCRPC and can significantly lower PSA levels. As yet we have no meaningful information about any effect on patient survival.

The trial is seeking to enroll 200 patients who have:

  • Prostate cancer proven by histopathology
  • Unresectable metastases
  • Progressive disease that is either docetaxel/cabazitaxel naive or has already been treated with docetaxel/cabazitaxel
  • Castration-resistant disease with a confirmed testosterone level ≤ 50 ng/ml under prior androgen deprivation therapy (ADT)
  • A positive 68Ga-PSMA-11 PET/CT scan or a diagnostic 177Lu-PSMA-617 scintigraphy scan
  • An ECOG score of 0-2

The trial will initially open at two centers (at the University of California Los Angeles and at the Excel Diagnostics and Nuclear Oncology Clinic in Houston, Texas). We assume that there may be other centers involved in this trial in the not too distant future.

Patients who are interested in seeking additional information about this trial can e-mail either Susan Cork or Iza Tworowska, PhD. We suggest you refer to the clinical trial identification code number: NCT03042312 in the header for any e-mail.

2 Responses

  1. Sorry — What is the message? Do you have data reported from the trial or is it just a reminder of a registered trial sill going on with no evaluation published so far?

    Finn von Eyben

  2. Dear Finn:

    This is a new trial here in the USA that will make it possible for US-based patients with mCRPC to get treatment with 177Lu-PSMA-617 here in America.

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