Clinical Trial of Ac225-PSMA Radioligand Therapy of Metastatic Castration-resistant Prostate Cancer
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Early Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: mCRPC for PSMA RLT 225Ac-PSMA 100KBq/kg, iv. Totally 2 doses, every 8 weeks. |
Drug: 225Ac-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.
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Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Pathologically confirmed prostatic adenocarcinoma.
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Clinically or imaging confirmed metastatic castration resistant prostate cancer.
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Conventional treatment failure or not available.
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PSMA avid of lesions confirmed by PSMA PET/CT.
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Hematopoietic function, kidney and liver function is normal.
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Can follow the study plan and can timely follow-up.
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Agree to sign the informed consent.
Exclusion Criteria:
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Pathological types other than the prostatic adenocarcinoma of prostate cancer.
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Not PSMA avid of lesions confirmed by PSMA PET/CT.
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Concurrent with other uncontrolled malignant tumours or five years, except for carcinoma in situ.
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Concomitant diseases are not suitable for radioactive therapy.
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Other conditions (religion, psychology, etc.) affect the informed consent, research plan, or not compliant of follow-up schedule.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
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- Asselah J, Sperlich C. Post-docetaxel options for further survival benefit in metastatic castration-resistant prostate cancer: Questions of choice. Can Urol Assoc J. 2013 Jan-Feb;7(1-2 Suppl 1):S11-7.
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- XHEC-C-2019-042-2