Advanced Accelerator Applications (Italy) Srl

To evaluate the efficacy of AAA617 compared with observation after stereotactic body radiation therapy (SBRT) in delaying castration or disease recurrence in adult patients with PSMA-positive OMPC with 1-5 metastases detected by PSMA PET using gallium (68Ga)gozetotide or piflufolastat (18F) and no M1 lesions on conventional imaging (CI).

To evaluate the efficacy and safety of AAA617 alone and in combination with an androgen receptor pathway inhibitor (ARPI) in subjects with PSMA-positive castration-resistant prostate cancer who have no evidence of metastasis on conventional imaging (CI; i.e., CT/MRI and bone scan).

The purpose of this study is to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), and radiation dosimetry of [177Lu]Lu-PSMA-617 added to best supportive/best standard of care (BSC/BSoC) in Chinese subjects with progressive PSMA-positive mCRPC who have received 1-2 prior taxane regimens and at least 1 novel androgen receptor pathway inhibitor (ARPI) therapy. In addition, the safety, PK, and radiation dosimetry of [68Ga]Ga-PSMA-11 were also evaluated. The data from this study will be used to bridge the global pivotal Phase III study (VISION, AAA617A12301) and support the registration of [177Lu]Lu-PSMA-617 as a novel anticancer therapy (i.e., radioligand therapy) for mCRPC in China.