Trial · NCT07096128
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 1.Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Through study completion, assessed up to 2 years | 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. |
| Primary | Dose-limiting toxicity（DLT） | Through study completion, assessed up to 2 years | Incidence and severity of dose-limiting toxicities. |
| Primary | Whole body and organ uptake of [177Lu]Lu-PSMA-XT Injection | From the first subject enrolled to one week after the last subject completed the first dosing,assessed up to approximately 12 months | 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. |
| Secondary | Best Percentage Change From Baseline in Prostate-specific Antigen (PSA) Level(PCWG3) | Through study completion, assessed up to 2 years. | Best percentage change from baseline in PSA level was defined as the maximum percent decrease at any time post-baseline. |
| Secondary | Prostate-specific Antigen 50 (PSA50) Response | Through study completion, assessed up to 2 years. | 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. |
| Secondary | Time to PSA progression | Through study completion, assessed up to 2 years. | 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. |
| Secondary | Radiographic Progression-free Survival (rPFS) | Through study completion, assessed up to 2 years. | 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. |
| Secondary | Overall Response Rate (ORR) | Through study completion, assessed up to 2 years. | 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. |
| Secondary | Duration of Response (DOR) | Through study completion, assessed up to 2 years. | 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 . |
| Secondary | Disease Control Rate (DCR) | Through study completion, assessed up to 2 years. | 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. |
| Secondary | Time to First Symptomatic Skeletal Event (SSE) | Through study completion, assessed up to 2 years. | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT07096128/registered