This was a multicenter, open-label, phase I study to evaluate the safety, tolerability, radiation dosimetry and efficacy of \[177Lu\] Lu-PSMA-XT injection in patients with metastatic prostate cancer .
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
\[177Lu\]Lu-PSMA-XT is a radioligand therapy that delivers beta-particle radiation to PSMA-expressing cells.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGMianyang Central Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe First Medical Center, Chinese PLA General Hospital
Beijing, Beijing Municipality, China
RECRUITING1.Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
To evaluate the safety and tolerability of \[177Lu\]Lu-PSMA-XT Injection assessed from the number and incidence of patients with adverse events using CTCAE v5.0 and physical examination, electrocardiogram and laboratory abnormality, etc.
Time frame: Through study completion, assessed up to 2 years
Dose-limiting toxicity（DLT）
Incidence and severity of dose-limiting toxicities.
Time frame: Through study completion, assessed up to 2 years
Whole body and organ uptake of [177Lu]Lu-PSMA-XT Injection
Quantitate the absorbed radiation doses (expressed as Gy/MBq) of administered \[177Lu\]Lu-PSMA-XT to kidneys, liver, lungs, spleen, bone/red marrow and salivary glands.
Time frame: From the first subject enrolled to one week after the last subject completed the first dosing,assessed up to approximately 12 months
Best Percentage Change From Baseline in Prostate-specific Antigen (PSA) Level(PCWG3)
Best percentage change from baseline in PSA level was defined as the maximum percent decrease at any time post-baseline.
Time frame: Through study completion, assessed up to 2 years.
Prostate-specific Antigen 50 (PSA50) Response
PSA50 response was defined as the proportion of participants who had a \>= 50% decrease in PSA from baseline confirmed by a PSA measurement \>= 4 weeks later.
Time frame: Through study completion, assessed up to 2 years.
Time to PSA progression
PSA progression was defined as: 1) Where a decline from baseline was documented, date that a \>= 25% increase in PSA and an absolute increase of 2 ng/mL or more from the nadir was documented and confirmed by a second consecutive value obtained at least 3 weeks later. Rises in PSA within the first 12 weeks of the date of first dose were ignored; 2) Where no decline from baseline was documented, PSA progression was defined as a \>= 25% increase from the baseline value along with an increase in absolute value of 2 ng/mL or more after 12 weeks from the date of first dose (without confirmation) as specified in the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) guidelines.
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Time frame: Through study completion, assessed up to 2 years.
Radiographic Progression-free Survival (rPFS)
Radiographic progression-free survival (rPFS) was defined as the time (in months) from the date of enrollment to the date of radiographic disease progression per the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria or death due to any cause.
Time frame: Through study completion, assessed up to 2 years.
Overall Response Rate (ORR)
Overall Response Rate (ORR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). ORR was based on RECIST 1.1 response for patients with measurable disease at baseline.
Time frame: Through study completion, assessed up to 2 years.
Duration of Response (DOR)
Duration of Response (DOR) was defined as the duration between the date of first documented Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) and the date of first documented radiographic progression or death due to any cause .
Time frame: Through study completion, assessed up to 2 years.
Disease Control Rate (DCR)
Disease control rate (DCR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) according to RECIST v1.1.
Time frame: Through study completion, assessed up to 2 years.
Time to First Symptomatic Skeletal Event (SSE)
Time to first Symptomatic Skeletal Event (SSE) was defined as the time (in months) from the date of enrollment to the date of the SSE or death from any cause. The SSE date was the date of first new symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgical intervention, requirement for radiation therapy to relieve bone pain, or death due to any cause.
Time frame: Through study completion, assessed up to 2 years.