CAAA617B12203: Lu-PSMA-617 in PSMA-PET Positive Castration-Resistant Prostate Cancer (CRPC)

• Research type

  Research Study

• Full title

  An International Prospective Open-label, Multi-center, Randomized, non-comparative Phase II Study of Lutetium [177Lu] vipivotide tetraxetan (AAA617) alone and Lutetium [177Lu] vipivotide tetraxetan (AAA617) in combination with Androgen Receptor Pathway Inhibitors in patients with PSMA PET scan positive Castration-Resistant Prostate Cancer

• IRAS ID

  1007078

• Contact name

  Daniel Monney

• Contact email

  daniel.monney@novartis.com

• Sponsor organisation

  Novartis Pharma AG

• Clinicaltrials.gov Identifier

  NCT05849298

• Research summary

  The purpose of this study is to evaluate the efficacy and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617) alone and in combination with an androgen receptor pathway inhibitor (ARPI) in participants with PSMA-positive, castration-resistant prostate cancer and no evidence of metastasis in conventional imaging (CI) (i.e., CT/MRI and bone scans).
  AAA617 is a type of therapy which specifically binds to prostate cancer cells with PSMA proteins on their surface (called PSMA-positive) and delivers radiation to kill specifically those cancer cells.
  ARPIs (in this study apalutamide, enzalutamide, and darolutamide) with ongoing Androgen deprivation therapy (ADT) are the standard of care in Castration Resistant Prostate Cancer. These medications work to inhibit the growth of prostate cancer cells blocking the androgens that would trigger the prostate cancer to grow. All study participants will receive ADT.
  Castration resistant prostate cancer (CRPC) is when the prostate cancer does not respond to castration therapies any longer, for example, there is a Prostate Specific Antigen (PSA) raise while a patient is under ADT. Metastatic disease (metastases) is when the prostate cancer has spread outside the primary site of origin (prostate) to other sites or organs (e.g., bone, lymph nodes, etc.). Usually, metastasis are seen in CI. In this study Positron Emission Tomography / Computed Tomography (PET/CT) scans will be performed as well using an imaging agent that detects PSMA-positive prostate cancer cells (PSMA PET/CT). PSMA PET/CT scan will be used to identify patients who are eligible to the study. Participants will also have PSMA PET/CT scans done regularly during study for exploratory purposes, to find out if AAA617 with or without combination with ARPI is safe and can help patients with resistant prostate cancer who do not show any metastases on CI but have a PSMA-positive prostate cancer to delay the progression of disease and improve the survival.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  24/NW/0088

• Date of REC Opinion

  16 Apr 2024

• REC opinion

  Further Information Favourable Opinion