Trial · NCT07096128
A Study of [177Lu] Lu-PSMA-XT Injection in Patients With Metastatic Prostate Cancer
NCT07096128, Phase 1, Recruiting, Jinming Zhang
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of [177Lu] Lu-PSMA-XT Injection in Patients With Metastatic Prostate Cancer. Trials, record NCT07096128. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07096128
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of [177Lu] Lu-PSMA-XT Injection in Patients With Metastatic Prostate Cancer
- NCT number
- NCT07096128
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 36 participants, estimated
- Lead sponsor
- Jinming Zhang
- Conditions
- mCRPC
- Interventions
- [177Lu]Lu-PSMA-XT
- First posted
- 2025-07-31
- Last updated
- 2025-07-31
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07096128
GET https://conductscience.org/api/trials/v1/NCT07096128/registered