A Study of [177Lu] Lu-PSMA-XT Injection in Patients With Metastatic Prostate Cancer
ConditionmCRPC
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorJinming Zhang
About this trial
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 .
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- [177Lu]Lu-PSMA-XT
Treatment groups
36 Participants
are divided into 1 treatment groupSponsors and collaborators
Jinming Zhang
Lead sponsor
Chinese PLA General Hospital
Sponsor institution
Sinotau Pharmaceutical Group
Collaborator
Source ClinicalTrials.gov