NCT04225910

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Jan 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2021

Completed
Last Updated

January 13, 2020

Status Verified

October 1, 2019

Enrollment Period

1.5 years

First QC Date

October 7, 2019

Last Update Submit

January 8, 2020

Conditions

Metastatic Castration-resistant Prostate Cancer

Keywords

mCRPC, PSMA radioligand therapy, efficacy, safety

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Adverse Events and Serious Adverse Events

    through study completion, an average of 1 year.

Study Arms (1)

mCRPC for PSMA RLT

EXPERIMENTAL

225Ac-PSMA 100KBq/kg, iv. Totally 2 doses, every 8 weeks.

Drug: 225Ac-PSMA

Interventions

225Ac-PSMADRUG

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.

mCRPC for PSMA RLT

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (15)

  • 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.

    PMID: 29313949BACKGROUND

  • 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.

    PMID: 25311767BACKGROUND

  • 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.

    PMID: 26041764BACKGROUND

  • 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. doi: 10.5489/cuaj.274.

    PMID: 23682301BACKGROUND

  • Tannock 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: 15470213BACKGROUND

  • 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.

    PMID: 18182665BACKGROUND

  • 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.

    PMID: 20888992BACKGROUND

  • 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, Flechon 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.

    PMID: 21612468BACKGROUND

  • 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, Flechon 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. doi: 10.1056/NEJMoa1207506. Epub 2012 Aug 15.

    PMID: 22894553BACKGROUND

  • Sartor O, Coleman R, Nilsson S, Heinrich D, Helle SI, O'Sullivan JM, Fossa 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 OS, 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.

    PMID: 24836273BACKGROUND

  • 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.

    PMID: 20818862BACKGROUND

  • 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.

    PMID: 28604117BACKGROUND

  • Kopka K, Benesova 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.

    PMID: 28864607BACKGROUND

  • 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.

    PMID: 28342027BACKGROUND

  • Kratochwil C, Bruchertseifer F, Rathke H, Bronzel M, Apostolidis C, Weichert W, Haberkorn U, Giesel FL, Morgenstern A. Targeted alpha-Therapy of Metastatic Castration-Resistant Prostate Cancer with 225Ac-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.

    PMID: 28408529BACKGROUND

MeSH Terms

Interventions

(225)Ac-PSMA-617

Central Study Contacts

Hui Wang, Professor

CONTACT

86-021-25076980wanghuishanghai@hotmaill.com

Hongliang Fu

CONTACT

86-021-25078591fuhongliang@hotmail.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2019

First Posted

January 13, 2020

Study Start

January 1, 2020

Primary Completion

June 30, 2021

Study Completion

December 21, 2021

Last Updated

January 13, 2020

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share