NCT03780075

Lu177-EB-PSMA617 Radionuclide Treatment in Patients With Metastatic Castration-resistant Prostate Cancer

Status unknown Phase 1 Last updated 12 May 2022

What this trial tests

Phase 1 trial testing 1.11GBq of 177Lu-EB-PSMA-617 in Metastatic Castration-resistant Prostate Cancer in 50 participants. Status unknown.

Timeline

15 April 2018

Primary endpoint
1 September 2020

1 December 2022

Quick facts

Lead sponsor	Peking Union Medical College Hospital
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	15 April 2018
Primary completion	1 September 2020
Estimated completion	1 December 2022
Sites	1 location across China

Drugs / interventions tested

• 1.11GBq of 177Lu-EB-PSMA-617 — full drug profile →
• 2.00 GBq of 177Lu-EB-PSMA-617 — full drug profile →
• 3.70GBq of 177Lu-EB-PSMA-617 — full drug profile →

Conditions studied

• Metastatic Castration-resistant Prostate Cancer — all drugs for Metastatic Castration-resistant Prostate Cancer →

Sponsor

Peking Union Medical College Hospital

Who can join

Adults 18 to 80, male only, with Metastatic Castration-resistant Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In prior studies, the investigators synthesized 177Lu-EB-PSMA-617 by conjugating a truncated Evans Blue (EB) molecule and DOTA chelator onto PSMA-617 and labeled it with 177Lu to increase the tumor accumulation and retention for radioligand therapy，and then the investigators evaluated the dosimetry of 177Lu-EB-PSMA-617 and response to single low-dose treatment in patients with metastatic castration-resistant prostate cancer(mCRPC). This study was performed to evaluate the safety and therapy response to 177Lu-EB-PSMA-617 in patients with mCRPC.

This is an open-label, randomized study. Different groups with doses of 1.11GBq (30 mCi), 2.00 GBq (54 mCi) and 3.7GBq (100 mCi)of 177Lu-EB -PSMA617 will be injected intravenously. All patients will undergo 68Ga-PSMA PET/CT scans before and after the treatment.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeted Radionuclide Therapy of Prostate Cancer-From Basic Research to Clinical Perspectives.
   Czerwińska M, Bilewicz A, Kruszewski M, Wegierek-Ciuk A, et al · · 2020 · cited 65× · PMID 32290196 · DOI 10.3390/molecules25071743
2. Status of PSMA-targeted radioligand therapy in prostate cancer: current data and future trials.
   Jang A, Kendi AT, Sartor O. · · 2023 · cited 63× · PMID 36895851 · DOI 10.1177/17588359231157632
3. Peptide Drug Conjugates and Their Role in Cancer Therapy.
   Heh E, Allen J, Ramirez F, Lovasz D, et al · · 2023 · cited 54× · PMID 36614268 · DOI 10.3390/ijms24010829
4. ¹⁷⁷Lu-EB-PSMA Radioligand Therapy with Escalating Doses in Patients with Metastatic Castration-Resistant Prostate Cancer.
   Zang J, Liu Q, Sui H, Wang R, et al · · 2020 · cited 40× · PMID 32358086 · DOI 10.2967/jnumed.120.242263
5. More Than Meets the Eye: Scientific Rationale behind Molecular Imaging and Therapeutic Targeting of Prostate-Specific Membrane Antigen (PSMA) in Metastatic Prostate Cancer and Beyond.
   Hyväkkä A, Virtanen V, Kemppainen J, Grönroos TJ, et al · · 2021 · cited 22× · PMID 34067046 · DOI 10.3390/cancers13092244
6. Innovation in Radionuclide Therapy for the Treatment of Prostate Cancers: Radiochemical Perspective and Recent Therapeutic Practices.
   Deshayes E, Fersing C, Thibault C, Roumiguie M, et al · · 2023 · cited 11× · PMID 37370743 · DOI 10.3390/cancers15123133
7. Current Status of PSMA-Targeted Radioligand Therapy in the Era of Radiopharmaceutical Therapy Acquiring Marketing Authorization.
   Oh SW, Suh M, Cheon GJ. · · 2022 · cited 9× · PMID 36425273 · DOI 10.1007/s13139-022-00764-4
8. A Treatment Paradigm Shift: Targeted Radionuclide Therapies for Metastatic Castrate Resistant Prostate Cancer.
   Parent EE, Kase AM. · · 2022 · cited 6× · PMID 36077820 · DOI 10.3390/cancers14174276