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

Early Phase 1

• Conditions: Metastatic Castration-resistant Prostate Cancer
• Interventions: Drug: 225Ac-PSMA

• Registration Number: NCT04225910
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-07
• Study Start: 2020-01-01
• Study First Submitted QC: 2020-01-08
• Last Update Submitted: 2020-01-08
• Study First Posted: 2020-01-13
• Last Update Posted: 2020-01-13
• Primary Completion: 2021-06-30
• Study Completion: 2021-12-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
mCRPC for PSMA RLT	225Ac-PSMA	225Ac-PSMA 100KBq/kg, iv. Totally 2 doses, every 8 weeks.

Primary Outcome Measures

Name	Time	Method
serum PSA level	through study completion, an average of 1 year	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%.

Secondary Outcome Measures

Name	Time	Method
Adverse Events and Serious Adverse Events	through study completion, an average of 1 year.	Adverse Events and Serious Adverse Events measured using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0