Prostate CancerNCT04560725
PSMA Specific [68Ga]-P137 Peptide Probe for PET Imaging in Prostate Cancer
A study testing 11C-Choline in people with Prostate Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
To study the radioactive uptake of [68Ga]P137 in the lesion sites of PCa patients and evaluate the ability of [68Ga]P137 to detect PSMA overexpression in PCa patients (especially those with recurrent or advanced PCa). Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- 11C-Choline
- 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
- 22 Oct 2020to 1 Dec 2024
- Phase
- Interventional
- 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 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men over 18 years of age need to undergo [68Ga]P137 PET/CT examination for suspected prostate cancer.
- The patients can fully understand and voluntarily participate in this experiment, and sign the informed consent.
Who cannot join
- Significant hepatic or renal dysfunction;
- Patients with malignant tumors other than prostate cancer within 2 years;
- Ready to pregnant;
- The patient can not tolerate all clinical tests.
Trial locations and contacts
1 site in 1 country.
About this study
To study the radioactive uptake of [68Ga]P137 in the lesion sites of PCa patients and evaluate the ability of [68Ga]P137 to detect PSMA overexpression in PCa patients (especially those with recurrent or advanced PCa).
Read the detailed description
Prostate cancer is the most common malignancy of the male reproductive system.Prostate specific membrane antigen is a highly specific prostatic epithelial cell membrane antigen, which is highly expressed in solid tumors such as prostate cancer. More than 90% of prostate cancer cells express PSMA, so PSMA can be used as an important imaging target for prostate cancer.Positron emission tomography has the advantages of non-invasive, high resolution and high sensitivity, etc. The PET tracer based on PSMA radiographic label is developing rapidly, which is of great significance for the early diagnosis, prognosis and treatment of prostate cancer.Used for radionuclide 68Ga has a half-life of PET imaging (T1/2 = 68 min) is appropriate, prepared from 68Ge-68Ga generator, relatively low cost, coordination marking method is simple, easy to realize automatic synthesis technology and advantages of medicine preparation, so 68Ga- labeled PSMA targeted molecular probe in prostate cancer has been widely applied in the diagnosis of disease.
[68Ga]P137 is a novel PSMA targeted molecular probe labeled with 68Ga. DOTA is used as a bifunctional linker to coordinate with 68Ga3+. The labeling method is simple, the biological stability is high, the tumor site has obvious radioactive enrichment, and the imaging effect is superior.This project provides research on [68Ga]P137 PET/CT imaging for patients with suspected PCa, and provides basis for early diagnosis of PCa, formulation of treatment plan and efficacy evaluation.
- Conditions
- Prostate Cancer
- Being tested
- 11C-Choline
- Keywords
- PSMA
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
11C-CholineDrug
Also called 11C-CH
11C-choline (0.05-0.1mCi/kg) was injected intravenously one week before or after the [68Ga]P137 PET/CT examination, and imaging of the head and body cadres was performed 20 min after the injection using Philips Gemini TF16 or Siemens Biograph M-CT flow PET/CT
| Study group | Role | What they receive |
|---|---|---|
| [68Ga] P137 | Experimental | Imaging cohort. All study participants will be allocated to this arm (single-arm study).Study participants will undergo [68Ga]P137 PET/CT scans. Receives: Drug: 11C-Choline |
What is being measured
The primary outcome is the main question the study is designed to answer.
SUV
The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value（SUV）on PET/CT
Measured: 2 years
Secondary outcomes (1)
ROC
The curve of the relationship between sensitivity and specificity
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start22 Oct 2020
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (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 Prostate CancerStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hua Zhu, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04560725
- Sponsor's protocol ID
- 2020KT107
- Status last verified
- Aug 2024
- First submitted
- 18 Sep 2020
- Last updated
- 19 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Duan X, Cao Z, Zhu H, Liu C, Zhang X, Zhang J, Ren Y, Liu F, Cai X, Guo X, Xi Z, Pomper MG, Yang Z, Fan Y, Yang X. 68Ga-labeled ODAP-Urea-based PSMA agents in prostate cancer: first-in-human imaging of an optimized agent. Eur J Nucl Med Mol Imaging. 2022 Feb;49(3):1030-1040. doi: 10.1007/s00259-021-05486-x. Epub 2021 Aug 28.
PubMed 34453203
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PSMA Specific [68Ga]-P137 Peptide Probe for PET Imaging in Prostate Cancer
- ClinicalTrials.gov ID
- NCT04560725
- Acronym / sponsor ID
- 2020KT107
- Conditions
- Prostate Cancer
- Keywords
- PSMA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 23 Sep 2020 (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.
To study the radioactive uptake of [68Ga]P137 in the lesion sites of PCa patients and evaluate the ability of [68Ga]P137 to detect PSMA overexpression in PCa patients (especially those with recurrent or advanced PCa).
Detailed description
Prostate cancer is the most common malignancy of the male reproductive system.Prostate specific membrane antigen is a highly specific prostatic epithelial cell membrane antigen, which is highly expressed in solid tumors such as prostate cancer. More than 90% of prostate cancer cells express PSMA, so PSMA can be used as an important imaging target for prostate cancer.Positron emission tomography has the advantages of non-invasive, high resolution and high sensitivity, etc. The PET tracer based on PSMA radiographic label is developing rapidly, which is of great significance for the early diagnosis, prognosis and treatment of prostate cancer.Used for radionuclide 68Ga has a half-life of PET imaging (T1/2 = 68 min) is appropriate, prepared from 68Ge-68Ga generator, relatively low cost, coordination marking method is simple, easy to realize automatic synthesis technology and advantages of medicine preparation, so 68Ga- labeled PSMA targeted molecular probe in prostate cancer has been widely applied in the diagnosis of disease.
[68Ga]P137 is a novel PSMA targeted molecular probe labeled with 68Ga. DOTA is used as a bifunctional linker to coordinate with 68Ga3+. The labeling method is simple, the biological stability is high, the tumor site has obvious radioactive enrichment, and the imaging effect is superior.This project provides research on [68Ga]P137 PET/CT imaging for patients with suspected PCa, and provides basis for early diagnosis of PCa, formulation of treatment plan and efficacy evaluation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [68Ga] P137 | Experimental | Drug: 11C-CholineImaging cohort. All study participants will be allocated to this arm (single-arm study).Study participants will undergo [68Ga]P137 PET/CT scans. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men over 18 years of age need to undergo [68Ga]P137 PET/CT examination for suspected prostate cancer.
- The patients can fully understand and voluntarily participate in this experiment, and sign the informed consent.
Key exclusion criteria (4 listed)
- Significant hepatic or renal dysfunction;
- Patients with malignant tumors other than prostate cancer within 2 years;
- Ready to pregnant;
- The patient can not tolerate all clinical tests.
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 |
|---|---|---|
| 11C-CholineAlso: 11C-CH11C-choline (0.05-0.1mCi/kg) was injected intravenously one week before or after the [68Ga]P137 PET/CT examination, and imaging of the head and body cadres was performed 20 min after the injection using Philips Gemini TF16 or Siemens Biograph M-CT flow PET/CT | Drug | [68Ga] P137 |
Primary outcome
SUV
Time frame: 2 years
The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value（SUV）on PET/CT
1 secondary outcome
ROC
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Derived from this study: PubMed 34453203Duan X, Cao Z, Zhu H, Liu C, Zhang X, Zhang J, Ren Y, Liu F, Cai X, Guo X, Xi Z, Pomper MG, Yang Z, Fan Y, Yang X. 68Ga-labeled ODAP-Urea-based PSMA agents in prostate cancer: first-in-human imaging of an optimized agent. Eur J Nucl Med Mol Imaging. 2022 Feb;49(3):1030-1040. doi: 10.1007/s00259-021-05486-x. Epub 2021 Aug 28.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 11C-Choline in people with Prostate Cancer, run by Peking University Cancer Hospital & Institute 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 4 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 19 Aug 2024. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SUV (time frame: 2 years). 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 NCT04560725, 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 19 Aug 2024.