Real-world Use of Lutetium (177Lu) Vipivotide Tetraxetan in China(PSMAreal CN)

Defined as the proportion of patients with a confirmed decrease in PSA levels by ≥50% from baseline

Defined as the proportion of patients with confirmed decreases in PSA level by ≥90% from baseline

Defined as the time from the index date to the first occurrence of PSA progression or radiographic progression according to the Prostate Cancer Working Group 3 criteria, clinical progression assessed by the investigator, or death due to any cause (whichever occurs first)

Defined as the time from the index date to the first occurrence of radiographic progression according to the PCWG3 criteria or death due to any cause (whichever occurs first)

Defined as the time from the index date to the first occurrence of clinical progression assessed by the investigator or death due to any cause (whichever occurs first). Clinical progression is determined by the investigator and may be based on the following criteria: 1) Significant increase in tumor pain requiring initiation of another systemic anti-cancer treatment regimen; 2) The need to immediately start new anti-cancer treatment, surgery, or radiotherapy intervention due to complications caused by tumor progression, even in the absence of radiographic progression; 3) Deterioration of Eastern Cooperative Oncology Group (ECOG) performance status to ≥ 3, and the investigator determines that the deterioration indicates clinical progression

Defined as the time from the index date to the first occurrence of PSA progression or death due to any cause. According to the PCWG3 criteria, PSA progression is defined as follows:

• For patients whose PSA has declined from baseline: PSA increased by ≥25% compared with the lowest value and the absolute value was ≥2 ng/mL, and was re-evaluated and confirmed after ≥3 weeks.
• For patients whose PSA has not declined from baseline: After at least 12 weeks of treatment with the study drug, the PSA level increased by ≥25% from the baseline and the absolute value was ≥2 ng/mL

Defined as the time from the initiation of the first subsequent systemic anti-tumor therapy following the end of treatment with lutetium (177Lu) vipivotide tetraxetan to the first occurrence of radiographic progression or PSA progression according to the PCWG3 criteria, clinical progression as assessed by the investigator, or death due to any cause (whichever occurs first)

Defined as the time from the index date to death due to any cause

Defined as the time from the index date to the first occurrence of an SSE. SSEs include the use of external beam radiation therapy to prevent or palliate skeletal symptoms, the occurrence of a new symptomatic pathological fracture (vertebral or non-vertebral), the occurrence of spinal cord compression, or tumor-related orthopedic surgical intervention (whichever occurs first)

Defined as the time from the index date to the start date of the first subsequent therapy for prostate cancer. Subsequent therapy refers to systemic anti-tumor treatment initiated after the patient discontinues lutetium (177Lu) vipivotide tetraxetan treatment

Defined as the proportion of patients with complete response (CR) / partial response (PR), and stable disease (SD) as the best response in soft tissue lesion evaluation

Defined as the proportion of patients with CR and PR as the best response in soft tissue lesion evaluation assessed referring to the evaluation criteria

Defined as the time from the index date to the first documentation of CR or PR for soft tissue lesions referring to the evaluation criteria

Defined as the time from the first documentation of objective response (CR or PR) to the first occurrence of disease progression (radiographic, clinical, or PSA progression) or death due to any cause (whichever occurs first)

Defined as the time from the index date to the occurrence of soft tissue progression referring to the evaluation criteria or death due to any cause (whichever occurs first)

Number of participants by treatment dose and cycles of lutetium (177Lu) vipivotide tetraxetan

Prior treatment lines and subsequent treatments (including: ARPI, ADT, chemotherapy, radical prostatectomy, radiological treatment etc.)

Typical Gleason Scores range from 6-10. The higher the Gleason Score, the more likely that the cancer will grow and spread quickly.

ECOG performance status is measured on a 6 point grade scale.

0: Fully active, able to carry on all pre-disease performance without restriction.

• Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
• Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.
• Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.
• Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.
• Dead.

The FACT-P was developed to measure the health-related quality of life (HRQOL) in patients diagnosed with prostate cancer. It extends the general FACT-G scale, which assesses cancer patients' overall quality of life, by adding specific items related to prostate cancer therapy. The FACT-P consists of two main sections:

• FACT-G: A general section that covers four domains: Physical Well-Being (PWB)，Social/Family Well-Being (SWB)，Emotional Well-Being (EWB)，Functional Well-Being (FWB)
• Prostate Cancer Specific Section: Focuses on issues unique to prostate cancer patients, such as urinary symptoms, sexual health, and the side effects of treatment.

The scoring system for the FACT-P uses a 5-point Likert scale (from 0 to 4，from good to bad). Scores are calculated across different domains and subscales, and the total score is calculated by summing the scores across all domains, providing a range of 0 to 156. A high FACT-P score indicates a worse outcome.

Brief Pain Inventory-Short Form (BPI-SF). The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. BPI assessment areas including severity of pain, impact of pain on daily function, location of pain, pain medications and amount of pain relief in the past 24 hours or the past week. No scoring algorithm, but "worst pain" or the arithmetic mean of the four severity items can be used as measures of pain severity; the arithmetic mean of the seven interference items can be used as a measure of pain interference.

EuroQol 5-Dimension 5-Level (EQ-5D-5L). The 5-level EQ-5D version (EQ-5D-5L) descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

Functional Assessment of Cancer Therapy - Radionuclide Therapy (FACT-RNT). The FACT-RNT was designed for use and future adaptation with a broad variety of RNT agents with different molecular targeting mechanisms and radioisotopes. The FACT-RNT, a 15-item measure of symptoms/toxicities with higher total scores(range:0-60) indicating less symptom burden.