Clinical trial · Interventional
Clinical Trial of Ac225-PSMA Radioligand Therapy of Metastatic Castration-resistant Prostate Cancer
Prospective Pilot Clinical Trial of Ac225-PSMA Radioligand Therapy of Metastatic Castration-resistant Prostate Cancer
NCT04225910CI-TRIAL-00042719unknownEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Castration-resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 225Ac-PSMA | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- mCRPC for PSMA RLT
- description
- 225Ac-PSMA 100KBq/kg, iv. Totally 2 doses, every 8 weeks.
- interventionNames
- Drug: 225Ac-PSMA
Primary outcomes (1)
- measure
- serum PSA level
- timeFrame
- through study completion, an average of 1 year
- description
- 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 outcomes (1)
- measure
- Adverse Events and Serious Adverse Events
- timeFrame
- through study completion, an average of 1 year.
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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.
References
Publications (15)
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- BACKGROUNDAsselah 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. doi: 10.5489/cuaj.274. PMID 23682301
- BACKGROUNDTannock IF, de Wit R, Berry WR, Horti J, Pluzanska A, Chi KN, Oudard S, Theodore C, James ND, Turesson I, Rosenthal MA, Eisenberger MA; TAX 327 Investigators. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004 Oct 7;351(15):1502-12. doi: 10.1056/NEJMoa040720. PMID 15470213
- BACKGROUNDBerthold DR, Pond GR, Soban F, de Wit R, Eisenberger M, Tannock IF. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer: updated survival in the TAX 327 study. J Clin Oncol. 2008 Jan 10;26(2):242-5. doi: 10.1200/JCO.2007.12.4008.