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

Shanghai Jiao Tong University

Status and phase

Unknown

Early Phase 1

Conditions

Metastatic Castration-resistant Prostate Cancer

Treatments

Drug: 225Ac-PSMA

Study type

Interventional

Funder types

Other

Identifiers

NCT04225910

XHEC-C-2019-042-2

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

Male

Volunteers

No Healthy Volunteers

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.