Clinical Trial · NCT04225910

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

Overview

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.

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Phase

Early Phase 1

Contacts

Hongliang Fu (CONTACT)

fuhongliang@hotmail.com

86-021-25078591

Hui Wang, Professor (CONTACT)

wanghuishanghai@hotmaill.com

86-021-25076980

ClinicalTrials.gov

NCT04225910

Drug / Compound

PSMA-617

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Chelator: DOTA

Eligibility

Inclusion

Pathologically confirmed prostatic adenocarcinoma.
Hematopoietic function, kidney and liver function is normal.
Clinically or imaging confirmed metastatic castration resistant prostate cancer.
PSMA avid of lesions confirmed by PSMA PET/CT.
Conventional treatment failure or not available.
Can follow the study plan and can timely follow-up.

Exclusion

Concomitant diseases are not suitable for radioactive therapy.
Not PSMA avid of lesions confirmed by PSMA PET/CT.
Concurrent with other uncontrolled malignant tumours or five years, except for carcinoma in situ.
Pathological types other than the prostatic adenocarcinoma of prostate cancer.