Study of Lutetium (177Lu) Vipivotide Tetraxetan in mCRPC Participants With Moderately and Severely Impaired and With Normal Renal Function

Eligibility Criteria

• 1. An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
• 2. 68Ga-PSMA-11 Positron emission tomography (PET)/CT scan positive, and eligible as determined by the sponsor's central reader.
• 3. A castrate level of serum/plasma testosterone (\< 50 ng/dL or \< 1.7 nmol/L).
• 4. Documented progressive mCRPC will be based on at least 1 of the following criteria:
• * Serum/plasma Prostate-Specific Antigen (PSA) progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal start value is 2.0 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: evaluable disease or new bone lesions(s) by bone scan (2+2 PCWG3 criteria)
• 5. Documented stable renal disease without evidence of renal progressive disease (stable renal disease is defined as no significant change, such as a stable eGFR, within 4 weeks prior to study entry)
• 6. Kidney function based on eGFR by Modification of Diet in Renal Disease (MDRD) equation:
• * Normal renal function: participants with eGFR \>= 90 mL/min
• * Moderate renal impairment: participants with eGFR \>= 30 to =\< 59 mL/min
• * Severe renal impairment: participants with eGFR \>= 15 to =\< 29 mL/min
• 1. Previous treatment with PSMA-targeted radioligand therapy.
• 2. Previous treatment with any of the following within 6 months of enrollment confirmation: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223 or hemi-body irradiation.
• 3. Use of agents known to prolong the QT interval from start of screening to end of Cycle 1, unless they can be permanently discontinued for the duration of study.
• 4. Current severe urinary incontinence, hydronephrosis, severe voiding dysfunction, any level of urinary obstruction requiring indwelling/condom catheters. Participants with postrenal impairment, like obstructions, retroperitoneal fibrosis (eg after prostectomy) must be excluded or first resolved to ≤ Grade 1.
• 5. History or current diagnosis of ECG abnormalities indicating significant risk of safety for participants participating in the study such as:
• * Concomitant clinically significant cardiac arrhythmias, e.g. sustained ventricular tachycardia, and clinically significant second- or third-degree AV block without a pacemaker.
• * History of familial long QT syndrome or known family history of Torsades de Pointe.
• * Resting heart rate (physical exam or 12 lead ECG) \<60 bpm