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

• Status: Not yet recruiting
• Trial end date: 2021-12-21
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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.