PSMAfore: A phase III Open-label Multi-Center Randomized Study Comparing 177Lu-PSMA-617 vs. a Change of androgen receptor-directed therapy in the Treatment of Taxane Na ve Men with Progressive Metastatic Castrate Resistant Prostate Cancer

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Prostate Cancer
  • Age: Between 18 years - 100 years
  • Gender: Male
  • Other Inclusion Criteria:
    1) Participants must have an ECOG performance status of 0 to 1. 2) Participants must have histological pathological, and/or cytological confirmation of adenocarcinoma of the prostate. 3) Participants must be 68Ga-PSMA-11 PET/CT scan positive, and eligible as determined by the sponsor's central reader Participants must have a castrate level of serum/plasma testosterone (< 50 ng/dL or < 1.7 nmol/L). 4) Participants must have received one prior approved ARDT (for example, abiraterone, enzalutamide, darolutamide, or apalutamide, etc.) and have documented progression on therapy.

You may not be eligible for this study if the following are true:

  • 1) Previous treatment with any of the following within 6 months of randomization: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation Previous PSMA-targeted radioligand therapy. 2) Prior treatment with cytotoxic chemotherapy for castration resistant or castrate sensitive prostate cancer (e.g., taxanes, platinum, estramustine, vincristine, methotrexate, etc.), immunotherapy or biological therapy [including monoclonal antibodies]). 3) Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression.

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