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Recruiting NCT07096128

A Study of [177Lu] Lu-PSMA-XT Injection in Patients With Metastatic Prostate Cancer

Phase I Interventional mCRPC

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: [177Lu]Lu-PSMA-XT.
Who it may be relevant to
Registry conditions: mCRPC. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase I Study to Assess the Safety, Tolerability, Radiation Dosimetry and Efficacy of [177Lu] Lu-PSMA-XT in Patients With Metastatic Prostate Cancer

Overview

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 .

Interventions

  • Drug [177Lu]Lu-PSMA-XT
    \[177Lu\]Lu-PSMA-XT is a radioligand therapy that delivers beta-particle radiation to PSMA-expressing cells.

Primary outcome measures

  • 1.Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Time frame: Through study completion, assessed up to 2 years]
  • Dose-limiting toxicity（DLT） [Time frame: Through study completion, assessed up to 2 years]
  • Whole body and organ uptake of [177Lu]Lu-PSMA-XT Injection [Time frame: From the first subject enrolled to one week after the last subject completed the first dosing,assessed up to approximately 12 months]
Secondary outcome measures (8)
  • Best Percentage Change From Baseline in Prostate-specific Antigen (PSA) Level(PCWG3) [Time frame: Through study completion, assessed up to 2 years.]
  • Prostate-specific Antigen 50 (PSA50) Response [Time frame: Through study completion, assessed up to 2 years.]
  • Time to PSA progression [Time frame: Through study completion, assessed up to 2 years.]
  • Radiographic Progression-free Survival (rPFS) [Time frame: Through study completion, assessed up to 2 years.]
  • Overall Response Rate (ORR) [Time frame: Through study completion, assessed up to 2 years.]
  • Duration of Response (DOR) [Time frame: Through study completion, assessed up to 2 years.]
  • Disease Control Rate (DCR) [Time frame: Through study completion, assessed up to 2 years.]
  • Time to First Symptomatic Skeletal Event (SSE) [Time frame: Through study completion, assessed up to 2 years.]

Eligibility criteria

Inclusion criteria

  • Patients must have the ability to understand and sign an approved informed consent form (ICF).
  • Patients must be >= 18 and <＝80 years of age.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Patients must have a life expectancy >6 months.
  • Patients must have histological, pathological, and/or cytological confirmation of prostate cancer.
  • Patients must be PSMA Positron Emission Tomography (PET)/Computed Tomography (CT) scan positive。
  • Patients must have a castrate level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L).
  • Patients must have received at least one NAAD (such as enzalutamide and/or abiraterone)； patients must have been previously treated undergone at least 1-2 prior taxane-based chemotherapy regimens or be unsuitable for taxane therapy (unsuitability includes contraindications, investigator-determined ineligibility, or patient refusal) in mCRPC stage.
  • Patients must have progressive mCRPC.
  • Patients must have adequate organ function。
  • Subjects of childbearing potential voluntarily use an effective method of contraception, such as condoms, oral or injectable contraceptives, Intra-uterine device（IUD）,etc., during treatment and within 6 months of the last use of the trial drug.

Exclusion criteria

  • Previous treatment with any of the following within 6 months of enrollment: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation. Previous PSMA-targeted radioligand therapy is not allowed.
  • Known other malignancies.
  • Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy within 28 days prior to day of enrollment.
  • Known hypersensitivity to the components of the study therapy or its analogs.
  • A superscan as seen in the baseline bone scan.
  • Patients with a history of Central Nervous System (CNS) metastases.
  • Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, cardiac arrhythmia, or other severe complications.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 3 centers
  • Beijing Cancer Hospital — Beijing
  • Mianyang Central Hospital — Beijing
  • The First Medical Center, Chinese PLA General Hospital — Beijing

Identifiers

NCT: NCT07096128 · IIT-XTR021-1-03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗