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

Metastatic Castration-resistant Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04225910
• Other study ID #: XHEC-C-2019-042-2
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: January 1, 2020
• Est. completion date: December 21, 2021

Study information

• Verified date: October 2019
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Hui Wang, Professor
• Phone: 86-021-25076980
• Email: wanghuishanghai[@]hotmaill.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 21, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Metastatic Castration-resistant Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

References & Publications (15)

Allen BJ. A comparative evaluation of Ac225 vs Bi213 as therapeutic radioisotopes for targeted alpha therapy for cancer. Australas Phys Eng Sci Med. 2017 Jun;40(2):369-376. doi: 10.1007/s13246-017-0534-6. Epub 2017 Mar 24. — View Citation

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. — View Citation

Berthold 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. — View Citation

de Bono JS, Logothetis CJ, Molina A, Fizazi K, North S, Chu L, Chi KN, Jones RJ, Goodman OB Jr, Saad F, Staffurth JN, Mainwaring P, Harland S, Flaig TW, Hutson TE, Cheng T, Patterson H, Hainsworth JD, Ryan CJ, Sternberg CN, Ellard SL, Fléchon A, Saleh M, Scholz M, Efstathiou E, Zivi A, Bianchini D, Loriot Y, Chieffo N, Kheoh T, Haqq CM, Scher HI; COU-AA-301 Investigators. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med. 2011 May 26;364(21):1995-2005. doi: 10.1056/NEJMoa1014618. — View Citation

de Bono JS, Oudard S, Ozguroglu M, Hansen S, Machiels JP, Kocak I, Gravis G, Bodrogi I, Mackenzie MJ, Shen L, Roessner M, Gupta S, Sartor AO; TROPIC Investigators. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet. 2010 Oct 2;376(9747):1147-54. doi: 10.1016/S0140-6736(10)61389-X. — View Citation

Gillessen S, Omlin A, Attard G, de Bono JS, Efstathiou E, Fizazi K, Halabi S, Nelson PS, Sartor O, Smith MR, Soule HR, Akaza H, Beer TM, Beltran H, Chinnaiyan AM, Daugaard G, Davis ID, De Santis M, Drake CG, Eeles RA, Fanti S, Gleave ME, Heidenreich A, Hussain M, James ND, Lecouvet FE, Logothetis CJ, Mastris K, Nilsson S, Oh WK, Olmos D, Padhani AR, Parker C, Rubin MA, Schalken JA, Scher HI, Sella A, Shore ND, Small EJ, Sternberg CN, Suzuki H, Sweeney CJ, Tannock IF, Tombal B. Management of patients with advanced prostate cancer: recommendations of the St Gallen Advanced Prostate Cancer Consensus Conference (APCCC) 2015. Ann Oncol. 2015 Aug;26(8):1589-604. doi: 10.1093/annonc/mdv257. Epub 2015 Jun 3. — View Citation

Kantoff PW, Higano CS, Shore ND, Berger ER, Small EJ, Penson DF, Redfern CH, Ferrari AC, Dreicer R, Sims RB, Xu Y, Frohlich MW, Schellhammer PF; IMPACT Study Investigators. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010 Jul 29;363(5):411-22. doi: 10.1056/NEJMoa1001294. — View Citation

Kopka K, Benešová M, Barinka C, Haberkorn U, Babich J. Glu-Ureido-Based Inhibitors of Prostate-Specific Membrane Antigen: Lessons Learned During the Development of a Novel Class of Low-Molecular-Weight Theranostic Radiotracers. J Nucl Med. 2017 Sep;58(Suppl 2):17S-26S. doi: 10.2967/jnumed.116.186775. Review. — View Citation

Kratochwil C, Bruchertseifer F, Rathke H, Bronzel M, Apostolidis C, Weichert W, Haberkorn U, Giesel FL, Morgenstern A. Targeted a-Therapy of Metastatic Castration-Resistant Prostate Cancer with (225)Ac-PSMA-617: Dosimetry Estimate and Empiric Dose Finding. J Nucl Med. 2017 Oct;58(10):1624-1631. doi: 10.2967/jnumed.117.191395. Epub 2017 Apr 13. — View Citation

Patrikidou A, Loriot Y, Eymard JC, Albiges L, Massard C, Ileana E, Di Palma M, Escudier B, Fizazi K. Who dies from prostate cancer? Prostate Cancer Prostatic Dis. 2014 Dec;17(4):348-52. doi: 10.1038/pcan.2014.35. Epub 2014 Oct 14. — View Citation

Sartor O, Coleman R, Nilsson S, Heinrich D, Helle SI, O'Sullivan JM, Fosså SD, Chodacki A, Wiechno P, Logue J, Widmark A, Johannessen DC, Hoskin P, James ND, Solberg A, Syndikus I, Vogelzang NJ, O'Bryan-Tear CG, Shan M, Bruland ØS, Parker C. Effect of radium-223 dichloride on symptomatic skeletal events in patients with castration-resistant prostate cancer and bone metastases: results from a phase 3, double-blind, randomised trial. Lancet Oncol. 2014 Jun;15(7):738-46. doi: 10.1016/S1470-2045(14)70183-4. Epub 2014 May 13. — View Citation

Scher HI, Fizazi K, Saad F, Taplin ME, Sternberg CN, Miller K, de Wit R, Mulders P, Chi KN, Shore ND, Armstrong AJ, Flaig TW, Fléchon A, Mainwaring P, Fleming M, Hainsworth JD, Hirmand M, Selby B, Seely L, de Bono JS; AFFIRM Investigators. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med. 2012 Sep 27;367(13):1187-97. Epub 2012 Aug 15. — View Citation

Siegel RL, Miller KD, Jemal A. Cancer statistics, 2018. CA Cancer J Clin. 2018 Jan;68(1):7-30. doi: 10.3322/caac.21442. Epub 2018 Jan 4. — View Citation

Summers N, Vanderpuye-Orgle J, Reinhart M, Gallagher M, Sartor O. Efficacy and safety of post-docetaxel therapies in metastatic castration-resistant prostate cancer: a systematic review of the literature. Curr Med Res Opin. 2017 Nov;33(11):1995-2008. doi: 10.1080/03007995.2017.1341869. Epub 2017 Jul 10. Review. — View Citation

Tannock IF, de Wit R, Berry WR, Horti J, Pluzanska A, Chi KN, Oudard S, Théodore 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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum PSA level	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%.	through study completion, an average of 1 year
Secondary	Adverse Events and Serious Adverse Events	Adverse Events and Serious Adverse Events measured using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	through study completion, an average of 1 year.