Metastatic Castration-resistant Prostate Cancer
Conditions
Keywords
mCRPC, PSMA radioligand therapy, efficacy, safety
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.
Interventions
DRUG225Ac-PSMA
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.
Sponsors
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Contacts
Primary ContactHui Wang, Professor
Backup ContactHongliang Fu
Outcome results
None listed