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

Recruiting now · Phase 1

Conditions studied: mCRPC

In brief

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 .

Key facts

Study ID

NCT07096128

Run by

Jinming Zhang

People needed

36

Starts

2024-08-20

Expected to finish

2027-04-30

Last updated by the study team

2025-07-31

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (enrolling)
• Mianyang Central Hospital — Beijing, Beijing Municipality, China (enrolling)
• The First Medical Center, Chinese PLA General Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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