Clinical Trial of Ac225-PSMA Radioligand Therapy of Metastatic Castration-resistant Prostate Cancer

Study Overview
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Brief Summary
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The death of prostate cancer patients is mainly due to metastatic castration-resistant prostate cancer. Though some new therapies has been tried to prolong the life-span of mCRPC patients, a dilemma was encountered for the drug-resistance. The PSMA RLT has been tested its efficacy and safety for the therapy of these patients. In our clinical trial, a new PSMA ligand will been used to be labeled with Ac225. This will be a prospective pilot clinical trial. 20 mCRPC patients who was incapable of 2rd ADT or chemotherapy will be recruited in this clinical tiral. The efficacy and safety of 225Ac-PSMA will be evaluated after the administration.

Official Title
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Prospective Pilot Clinical Trial of Ac225-PSMA Radioligand Therapy of Metastatic Castration-resistant Prostate Cancer

Conditions
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Metastatic Castration-resistant Prostate Cancer

Intervention / Treatment
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* Drug: 225Ac-PSMA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically confirmed prostatic adenocarcinoma. Clinically or imaging confirmed metastatic castration resistant prostate cancer. Conventional treatment failure or not available. PSMA avid of lesions confirmed by PSMA PET/CT. Hematopoietic function, kidney and liver function is normal. Can follow the study plan and can timely follow-up. Agree to sign the informed consent. Exclusion Criteria: Pathological types other than the prostatic adenocarcinoma of prostate cancer. Not PSMA avid of lesions confirmed by PSMA PET/CT. Concurrent with other uncontrolled malignant tumours or five years, except for carcinoma in situ. Concomitant diseases are not suitable for radioactive therapy. Other conditions (religion, psychology, etc.) affect the informed consent, research plan, or not compliant of follow-up schedule.
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mCRPC for PSMA RLT<br>225Ac-PSMA 100KBq/kg, iv. Totally 2 doses, every 8 weeks. | Drug: 225Ac-PSMA<br>* all the patients will receive 225Ac-PSMA RLT for 2 cycles. The dosage will be calculated according to 100KBq/kg body weight. The drug will be administered by vein injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum PSA level | Serum prostate specific antigen (PSA) levels was used as the main marker of efficacy evaluation, and the changes of PSA level were divided into decrease > 50%, 30%   50% and < 30%. | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events and Serious Adverse Events | Adverse Events and Serious Adverse Events measured using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 | through study completion, an average of 1 year. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mCRPC, PSMA radioligand therapy, efficacy, safety