[Ac-225]-PSMA-62 Phase I/II Clinical Trial to Characterize Efficacy, Safety, Tolerability, and Dosimetry in Oligometastatic Hormone Sensitive and Metastatic Castration Resistant Prostate Cancer (ACCEL)
ACCEL is a multicenter, open label phase Ia/Ib/II study of \[Ac-225\]-PSMA-62 in participants with prostate-specific membrane antigen (PSMA)-positive prostate cancer.
• Histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate
• ECOG performance status 0 to 1
• Criteria specific for patients with mCRPC:
‣ Previously received an androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy (unless ineligible or refused taxane). Received a maximum of 3 prior systemic therapy regimens in the mCRPC setting
⁃ Progressive mCRPC at the time of consent based on at least 1 of the following criteria being met in the context of castrate levels of testosterone:
• PSA progression defined as rising PSA values at a minimum of 1-week intervals, with the last result being at least 1.0 ng/mL
∙ Soft-tissue progression defined as an increase ≥20% in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of one or more new lesions
∙ Progression of bone disease defined as the appearance of two or more new lesions by bone scan
⁃ At least one PSMA-PET positive lesion for prostate cancer
⁃ Castrate circulating testosterone levels (\<1.74 nmol/L or \<50 ng/dL)
• Criteria specific for patients with OmHSPC:
‣ PSA recurrence after radical prostatectomy (RP) or definitive radiation therapy (RT), with or without adjuvant/salvage local therapy (radiation or surgery), with or without (neo)adjuvant ADT
• PSA ≥ 0.2ng/mL for patients with prior RP +/- RT, or
∙ PSA of ≥ 2 ng/mL above nadir for patients with only prior RT
⁃ 1- 5 PSMA-PET positive lesions identified outside the prostate bed or remaining gland.