Evaluate Safety, Whole-Body Distribution and Radiation Dosimetry in Metastatic Castration Resistant Prostate Cancer

Korábbi kezelés

• Less than 4 weeks since last myelosuppressive therapy (including prior radiotherapy or prior treatment with 223Radium, 89Strontium or 153Samarium containing compounds).
• Have used any other investigational drugs within 4 weeks or 5 half-lives (whichever is shorter) prior to the start of the study treatment, or have used any investigational medical devices within 4 weeks prior to the start of the study treatment, and plan to receive other investigational drugs or medical devices during the course of this study.
• Previously known to have a history of allergy, hypersensitivity, or intolerance to radioactive drugs; or known to be allergic to ethanol.

Más betegség

• Participants with any medical condition or other circumstances that, in the opinion of the investigator, would preclude participation in this study, compromise obtaining reliable data, achieving study objectives, or completion.
• With active or uncontrolled infection.

Egyéb

• Pathological findings consistent with small cell and/or neuroendocrine carcinoma of the prostate or any other histology not consistent with prostate adenocarcinoma.
• Participants with any PSMA-negative metastatic lesion these criteria were ineligible.
• Participants who have a pregnant partner or are capable of fathering a child and who are unwilling to take precautions to prevent potential harm to the fetus or prevent pregnancy during and for 90 days after discontinuation of study treatment.

• Participants provide signed informed consent and confirm that they are able and willing to comply with all protocol requirements.
• Participants must be ≥18 years of age and competent to give informed consent.
• Participants must have progressive mCRPC with histologically or cytologically confirmed adenocarcinoma of the prostate. Participants must have documented PSA and/or radiographic progression.
• Participants must have Gallium 68 PSMA-11 (Ga 68 PSMA-11) Positron Emission Tomography (PET)/Computed Tomography (CT) prostate-specific membrane antigen (PSMA) positive lesions ≤ 30 days prior to beginning study therapy.
• Participant has not received any form of prostate-cancer directed therapy since undergoing screening PSMA scan.
• Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
• Participants must have a life expectancy of more than 3 months.
• Effective castration with testosterone level of <50 ng/dL and plan to continue with chronic medical or surgical castration.
• Participants must have adequate hematological and organ function.