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A Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of [225Ac]Ac-PSMA-XT Injection in Patients With Metastatic Castration-resistant Prostate Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE1

A Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of [225Ac]Ac-PSMA-XT Injection in Patients With Metastatic Castration-resistant Prostate Cancer

NCT07135102•Xiaorong Sun

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine the safety and efficacy of 225Ac -labeled PSMA ligand(PSMA-XT) in the treatment of mCRPC

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. have the ability to understand and sign an approved informed consent form (ICF).
•2. \>= 18 years old.
•3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
•4. have a life expectancy \>6 months.
•5. have histological, pathological, and/or cytological confirmation of prostate cancer.
•6. PSMA Positron Emission Tomography (PET)/Computed Tomography (CT) scan positive
•7. have a castrate level of serum/plasma testosterone (\<50 ng/dL or \<1.7 nmol/L).
•8. 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.
•9. progressive mCRPC.
•10. have adequate organ function。
+1 more criteria

Exclusion Criteria

•1. 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.
•2. Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy within 28 days prior to day of enrollment.
•3. Known hypersensitivity to the components of the study therapy or its analogs.
•4. A superscan as seen in the baseline bone scan.
•5. Patients with a history of Central Nervous System (CNS) metastases.
•6. Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, cardiac arrhythmia, or other severe complications.

Locations (1)

Cancer Hospital of Shandong First Medical University

Jinan, Shandong, China

Key Dates

Start Date

October 14, 2024

Primary Completion Date

December 31, 2026

Completion Date

June 1, 2027

Last Updated

August 24, 2025

Enrollment

ESTIMATED participants

Conditions

Metastatic Castration-Resistant Prostate Cancer Patients

Interventions

225Ac-PSMA-XT

DRUG

A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001)

NCT07103018

Metastatic Castration-resistant Prostate CancerMetastatic Castration-Resistant Prostate Cancer Patients+3 more

View study

COMPLETEDPHASE2

Irofulven in AR-targeted and Docetaxel-Pretreated mCRPC Patients With Drug Response Predictor (DRP®)

NCT03643107

Metastatic Castration-Resistant Prostate Cancer Patients

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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