Clinical trial NCT04225910: Clinical Trial of Ac225-PSMA Radioligand Therapy of Metastatic Castration-resistant Prostate Cancer
Official title: Prospective Pilot Clinical Trial of Ac225-PSMA Radioligand Therapy of Metastatic Castration-resistant Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Metastatic Castration-resistant Prostate Cancer
Keywords: mCRPC, PSMA radioligand therapy, efficacy, safety
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 20
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: serum PSA level
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Adverse Events and Serious Adverse Events
timeFrame: through study completion, an average of 1 year.
Other outcomes:
Locations:
Study officials:
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