Metastatic Castration-resistant Prostate CancerPhase 1NCT03780075
Lu177-EB-PSMA617 Radionuclide Treatment in Patients With Metastatic Castration-resistant Prostate Cancer
A Phase 1 study testing 1.11GBq of 177Lu-EB-PSMA-617, 2.00 GBq of 177Lu-EB-PSMA-617 and 3.70GBq of 177Lu-EB-PSMA-617 in people with Metastatic Castration-resistant Prostate Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer
- What is being tested?
- 1.11GBq of 177Lu-EB-PSMA-617, 2.00 GBq of 177Lu-EB-PSMA-617 and 3.70GBq of 177Lu-EB-PSMA-617
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2018to 1 Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- cardiac insufficiency including carcinoid heart valve disease,
- a severe allergy or hypersensitivity to radiographic contrast material,
- claustrophobia, and pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing
Jie Zang, MD, 15901495106@163.com
About this study
Official title: Lu177-EB-PSMA617 Prostate-Specific Membrane Antigen Inhibitor Therapy in Patients With Castration-Resistant Prostate Cancer
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.
Read the 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.
- Being tested
- 1.11GBq of 177Lu-EB-PSMA-617, 2.00 GBq of 177Lu-EB-PSMA-617, 3.70GBq of 177Lu-EB-PSMA-617
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1.11GBq of 177Lu-EB-PSMA-617Drug
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.
2.00 GBq of 177Lu-EB-PSMA-617Drug
Patients were intravenous injected with the dose about 2.00 GBq (54 mCi) of 177Lu-EB-PSMA-617 every 8 weeks (±1 week) for a maximum of 3 cycles.
3.70GBq of 177Lu-EB-PSMA-617Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 1.11GBq of 177Lu-EB-PSMA-617 | Experimental | 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. Receives: Drug: 1.11GBq of 177Lu-EB-PSMA-617 |
| 2.00 GBq of 177Lu-EB-PSMA-617 | Experimental | The patients were intravenously injected with the dose about 2.00 GBq (54 mCi) of 177Lu-EB-PSMA-617 and underwent 68Ga-PSMA PET/CT scans before and after the treatment. Receives: Drug: 2.00 GBq of 177Lu-EB-PSMA-617 |
| 3.70GBq of 177Lu-EB-PSMA-617 | Experimental | 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. Receives: Drug: 3.70GBq of 177Lu-EB-PSMA-617 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the PSA and standardized uptake value of 68Ga-PSMA before and after the treatment in mCRPC
The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake in lesions will be measured.
Measured: 1 year
Secondary outcomes (1)
Adverse events collection
Adverse events after the treatment of patients will be followed and assessed
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start15 Apr 2018
- Primary completion1 Sep 2020
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Castration-resistant Prostate CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Responsible party
- Sponsor
- Investigators
- Zhaohui Zhu, MD,PHD, Study chair, Peking Union Medical College Hospital, Chinese Academy of Medical Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03780075
- Sponsor's protocol ID
- PekingUMCH-NM019
- Status last verified
- May 2022
- First submitted
- 17 Dec 2018
- Last updated
- 12 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen X, Peng Y, Zheng Q, Lai Y, Cheng H, Zhu Z, Wang G, Zang J. The Prognostic Value of 68Ga-PSMA and 18F-FDG PET/CT in Metastatic Castration-Resistant Prostate Cancer Treated with 177Lu-EB-PSMA. Ann Nucl Med. 2026 Jul 1. doi: 10.1007/s12149-026-02250-9. Online ahead of print.
PubMed 42384311
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lu177-EB-PSMA617 Prostate-Specific Membrane Antigen Inhibitor Therapy in Patients With Castration-Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT03780075
- Acronym / sponsor ID
- PekingUMCH-NM019
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 19 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1.11GBq of 177Lu-EB-PSMA-617 | Experimental | Drug: 1.11GBq of 177Lu-EB-PSMA-617The 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. |
| 2.00 GBq of 177Lu-EB-PSMA-617 | Experimental | Drug: 2.00 GBq of 177Lu-EB-PSMA-617The patients were intravenously injected with the dose about 2.00 GBq (54 mCi) of 177Lu-EB-PSMA-617 and underwent 68Ga-PSMA PET/CT scans before and after the treatment. |
| 3.70GBq of 177Lu-EB-PSMA-617 | Experimental | Drug: 3.70GBq of 177Lu-EB-PSMA-617The 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1.11GBq of 177Lu-EB-PSMA-617Patients 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. | Drug | 1.11GBq of 177Lu-EB-PSMA-617 |
| 2.00 GBq of 177Lu-EB-PSMA-617Patients were intravenous injected with the dose about 2.00 GBq (54 mCi) of 177Lu-EB-PSMA-617 every 8 weeks (±1 week) for a maximum of 3 cycles. | Drug | 2.00 GBq of 177Lu-EB-PSMA-617 |
| 3.70GBq of 177Lu-EB-PSMA-617Patients 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. | Drug | 3.70GBq of 177Lu-EB-PSMA-617 |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
- Derived from this study: PubMed 42384311Chen X, Peng Y, Zheng Q, Lai Y, Cheng H, Zhu Z, Wang G, Zang J. The Prognostic Value of 68Ga-PSMA and 18F-FDG PET/CT in Metastatic Castration-Resistant Prostate Cancer Treated with 177Lu-EB-PSMA. Ann Nucl Med. 2026 Jul 1. doi: 10.1007/s12149-026-02250-9. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhaohui Zhu, MD,PHD study chair
Peking Union Medical College Hospital, Chinese Academy of Medical Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 1.11GBq of 177Lu-EB-PSMA-617, 2.00 GBq of 177Lu-EB-PSMA-617 and 3.70GBq of 177Lu-EB-PSMA-617 in people with Metastatic Castration-resistant Prostate Cancer, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Zang, MD (+86 10 69154196, 15901495106@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the PSA and standardized uptake value of 68Ga-PSMA before and after the treatment in mCRPC (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03780075, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2022; AzTrials last refreshed its copy on 8 Nov 2026.