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

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ClinicalTrials.gov Identifier: NCT03780075
Recruitment Status : Unknown
Verified August 2019 by Peking Union Medical College Hospital.
Recruitment status was:  Recruiting
First Posted : December 19, 2018
Last Update Posted : August 26, 2019
Sponsor:
Collaborator:
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Brief Summary:

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), 1.85GBq (50 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.


Condition or disease Intervention/treatment Phase
Metastatic Castration-resistant Prostate Cancer Drug: 1.11GBq of 177Lu-EB-PSMA-617 Drug: 1.85GBq of 177Lu-EB-PSMA-617 Drug: 3.70GBq of 177Lu-EB-PSMA-617 Phase 1

Detailed Description:

Prostate cancer (PC) is the second most common cancer worldwide in men, with persistently high numbers dying from this disease. Recent studies have demonstrated the possibility of 177Lu-PSMA-617 therapy as a viable treatment option in mCRPC. To increase tumor accumulation and retention for radioligand therapy, and reduce dosage of 177Lu, the investigators conjugated a truncated Evans blue (EB) molecule and DOTA chelator onto PSMA-617 (EB-PSMA-617) and label it with 177Lu.

The study is open-label and patients will be divided into three groups and monitored throughout the 6 to 10-month treatment period for survival, disease progression, and adverse events to evaluate the safety and therapy response to the 177Lu-EB-PSMA-617.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lu177-EB-PSMA617 Prostate-Specific Membrane Antigen Inhibitor Therapy in Patients With Castration-Resistant Prostate Cancer
Actual Study Start Date : April 15, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: 1.11GBq of 177Lu-EB-PSMA-617
The patients were intravenously injected with the dose about 1.11GBq (30 mCi) of 177Lu-EB-PSMA617 and underwent 68Ga-PSMA PET/CT scans before and after the treatment.
Drug: 1.11GBq of 177Lu-EB-PSMA-617
Patients were intravenous injected with the dose about 1.11GBq (30 mCi) of 177Lu-EB-PSMA-617 every 8 weeks (±1 week) for a maximum of 3 cycles.

Experimental: 1.85GBq of 177Lu-EB-PSMA-617
The patients were intravenously injected with the dose about 1.85GBq (50 mCi) of 177Lu-EB-PSMA617 and underwent 68Ga-PSMA PET/CT scans before and after the treatment.
Drug: 1.85GBq of 177Lu-EB-PSMA-617
Patients were intravenous injected with the dose about 1.85GBq (50 mCi) of 177Lu-EB-PSMA-617 every 8 weeks (±1 week) for a maximum of 3 cycles.

Experimental: 3.70GBq of 177Lu-EB-PSMA-617
The patients were intravenously injected with the dose about 3.70GBq (100 mCi) of 177Lu-EB-PSMA617 and underwent 68Ga-PSMA PET/CT scans before and after the treatment.
Drug: 3.70GBq of 177Lu-EB-PSMA-617
Patients were intravenous injected with the dose about 3.70GBq (100 mCi) of 177Lu-EB-PSMA-617 every 8 weeks (±1 week) for a maximum of 3 cycles.




Primary Outcome Measures :
  1. Change of the PSA and standardized uptake value of 68Ga-PSMA before and after the treatment in mCRPC [ Time Frame: 1 year ]
    The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake in lesions will be measured.


Secondary Outcome Measures :
  1. Adverse events collection [ Time Frame: patients will be monitored throughout the whole treatment period. Patients will be followed up every 3 month until 1 year for a long-term follow-up period. ]
    Adverse events after the treatment of patients will be followed and assessed



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • progressive metastatic castration-resistant prostate cancer that did not respond to androgen-suppression therapy and/or systemic chemotherapy.
  • Distant metastases with high PSMA expression confirmed by 68Ga-PSMA PET/CT within one week before the injection of 177Lu-EB-PSMA-617.

Exclusion Criteria:

  • a serum creatinine level of more than 150μmol per liter,
  • a hemoglobin level of less than 10.0 g/dl,
  • a white-cell count of less than 4.0× 109/L,
  • a platelet count of less than 100 × 109/L,
  • a total bilirubin level of more than 3 times the upper limit of the normal range,
  • a serum albumin level of more than 3.0 g per deciliter,
  • cardiac insufficiency including carcinoid heart valve disease,
  • a severe allergy or hypersensitivity to radiographic contrast material,
  • claustrophobia, and pregnancy or breastfeeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03780075


Contacts
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Contact: Jie Zang, MD +86 10 69154196 15901495106@163.com

Locations
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China
Peking Union Medical College Hospital Recruiting
Beijing, China
Contact: Jie Zang, MD       15901495106@163.com   
Sponsors and Collaborators
Peking Union Medical College Hospital
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Investigators
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Study Chair: Zhaohui Zhu, MD,PHD Peking Union Medical College Hospital, Chinese Academy of Medical Science
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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03780075    
Other Study ID Numbers: PekingUMCH-NM019
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
177Lu-EB-PSMA-617
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action