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PIPELINE > TRIAL OVERVIEW

Trial Information
Molecule Overview
Prostate-Specific Membrane Antigen (PSMA) Radioligand
[Ac-225]-PSMA-62
Phase
1
Enrolling
[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 Cancera
Related Resources:
Molecule Overview Trial Enrollment
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Key Inclusion Criteria
  • Histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Criteria specific for patients with metastatic castration-resistant prostate cancer (mCRPC):
    • Previously received:
      • An androgen receptor pathway inhibitor (ARPI)
      • Taxane-based chemotherapy, or was deemed ineligible for taxane by the investigator, or refused taxane
      • 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:
      • Prostate-specific antigen (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 prostate-specific membrane antigen (PSMA)-positron emission tomography (PET) positive lesion for prostate cancer
  • Criteria specific for patients with oligometastatic hormone-sensitive prostate cancer (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 androgen deprivation therapy (ADT)
      • PSA must be ≥0.2 ng/mL for patients with prior RP ± RT, or
      • PSA must be ≥2 ng/mL above nadir for patients with only prior RT
    • 1-5 positive lesions identified outside the prostate bed or remaining gland
Key Exclusion Criteria
  • Patients receiving medications that are known to cause xerostomia or xerophthalmia (eg, darifenacin)
    are excluded if they are not on stable doses for at least 4 weeks prior to screening
  • Existing Grade 1 dry mouth (xerostomia) or symptomatic Grade 1 dry eye (xerophthalmia) for any reason
  • Criteria specific for patients with mCRPC:
    • Patient has received any PSMA-directed radioligand therapy (eg, [Lu-177]-PSMA-617, [Lu-177]-PNT2002, [Ac-225]-J591)
    • Patient has received any therapeutic systemic radionuclides (eg, radium-223, rhenium-186, strontium-89) or non-PSMA-directed therapeutic radioligands (eg, Lu-177-Dotatate) within 5 half-lives of starting the study treatment
  • Criteria specific for patients with OmHSPC:
    • Patient has received any systemic anticancer therapy for prostate cancer with the exception of
      (neo)adjuvant ADT for management of localized disease
    • Presence of liver or central nervous system (CNS) metastases
a
This clinical trial is currently being conducted in Canada.
b
Administered intravenously.
For information on trial enrollment, locations, and more, call 1-800-545-5979.
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