Prostate CancerEarly Phase 1NCT04158817
68Ga-THP-PSMA PET/CT in Prostate Cancer: Clinical Stage and Restage
A Early Phase 1 study testing 68Ga-Labeled PSMA and Non-labeled PSMA in people with Prostate Cancer, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
To evaluate the dosimetry, safety and the detection rate of 68Ga-THP-PSMA PET/CT for identifying the site of prostate cancer metastasis and relapse. It is also to evaluate the association of clinical/pathologic features and 68Ga-THP-PSMA PET/CT detection rate and compare 68Ga-THP-PSMA PET/CT with other imaging… Read more about this study
- Who is it for?
- Ages 18 to 79 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- 68Ga-Labeled PSMA and Non-labeled PSMA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2019to 31 Mar 2023
- Phase
- Early 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 79 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male, age 18 years or older
- Prior diagnosis of prostatic cancer
- Willing to participate in this study and given written informed consent
- AST, ALT, BUN, Cr not more than double the normal values
- Subjects of childbearing potential must be willing to undergo a pregnancy test prior to enrolment
Who cannot join
- Subjects with pacemakers
- Hepatitis B virus infection (including carriers) at screening, i.e. hepatitis B surface antigen (HBsAg) positive, or hepatitis C antibody (anti-HCV) positive, or acquired immunodeficiency disease (HIV) infected, or serum syphilis positive person
- Abnormal liver function during baseline screening period: AST or ALT> 2 times the upper limit of normal value (ULN), if the marginal increase of a single index is judged as having no clinical significance by the investigator, it can be retested during the screening period. Once, if more than 2 times ULN after retesting, consider enrolling).
- Impaired renal function during screening: serum creatinine or urea nitrogen > 1.5 times ULN.
- Within 4 months prior to the baseline screening period, myocardial infarction or other cardiac events requiring hospitalization (unstable angina, etc.), cerebrovascular accident, transient ischemic attack, acute congestive Heart failure or severe arrhythmia (ventricular arrhythmia, atrioventricular block above II)
- Subjects with pulmonary embolism or deep vein thrombosis
- Various infections that the investigators consider unsuitable for study, including but not limited to patients with various infections requiring further treatment, such as urinary tract infections, respiratory infections, and diabetic foot infections.
- Patients with abnormal thyroid function during baseline screening period (including but not limited to active hyperthyroidism, hypothyroidism or Hashimoto's thyroiditis)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gallium-68 Labelled THP-PSMA for the Clinical Stage and Restage of Prostate Cancer Patients
To evaluate the dosimetry, safety and the detection rate of 68Ga-THP-PSMA PET/CT for identifying the site of prostate cancer metastasis and relapse. It is also to evaluate the association of clinical/pathologic features and 68Ga-THP-PSMA PET/CT detection rate and compare 68Ga-THP-PSMA PET/CT with other imaging procedure.
- Conditions
- Prostate Cancer
- Being tested
- 68Ga-Labeled PSMA, Non-labeled PSMA
- Keywords
- 68Ga-THP-PSMA, PET/CT
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-Labeled PSMADrug
Also called 68Ga-THP-PSMA
All participants in the study will be injected with 68Ga-THP-PSMA at a dose of 2.11 MBq/kg in a single dose injection.
Non-labeled PSMADrug
Also called THP-PSMA
Patient will be injected with microdose (<100 ug) of THP-PSMA
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | All Prostate cancer patients recruited to the study will be administered 2.11 MBq/kg of 68Ga-THP-PSMA in a single dose injection. Receives: Drug: 68Ga-Labeled PSMA; Drug: Non-labeled PSMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximal standard uptake value
The tumor SUVmax of patients will be measured using Region Of Interest.
Measured: 2 years
The measurement of PSA
The PSA level (ng/mL) of patients will be tested by hemanalysis
Measured: 2 years
68Ga-THP-PSMA PET/CT in prostate cancer: clinical stage and restage
Visual analysis will be carried out by 4 experienced nuclear medicine physicians to observe the uptake of 68Ga-THP-PSMA in prostate malignant lesions. A 4 point method will be used to interpret the scans for abnormalities. It is categorized as such: score 0, no abnormal increased uptake; score 1, low increased uptake; score 2, moderate increased uptake; score 3, high increased uptake. The lesion will be considered positive for malignancy if the score is 2 or higher.
Measured: 2 years
Secondary outcomes (3)
The correlation analysis
The IHC results of prostate malignant lesions will be used as golden standard to evaluate the sensitivity and specificity of 68Ga-THP-PSMA PET/CT.
Measured: 2 years
The dosimetry assessment
To evaluate the dosimetry of 68Ga-THP-PSMA, patients (n = 5) will undergo whole-body planar imaging at different time points (10 min, 1 h, 2 h and 3 h after injection) to obtain radiation dosimetry data. A calibration source of 37 MBq at injection time will be placed above the head of each patient to provide quantitative calibration of counts to activity.
Measured: 2 years
The safety evaluation
Drug-related adverse reactions will be recorded during the 7-d follow-up period.
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 posted12 Nov 2019
- Study start1 Nov 2019
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- NanoMab Technology (UK) Limited
- Responsible party
- Principal investigator, Zhao Jin Hua, MD, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Jinhua Zhao, PhD, Principal investigator, Department of Nuclear Medicine, Shanghai General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04158817
- Sponsor's protocol ID
- [2018]15
- Status last verified
- Apr 2023
- First submitted
- 22 Oct 2019
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gallium-68 Labelled THP-PSMA for the Clinical Stage and Restage of Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT04158817
- Acronym / sponsor ID
- [2018]15
- Conditions
- Prostate Cancer
- Keywords
- 68Ga-THP-PSMA, PET/CT
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- NanoMab Technology (UK) Limited
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 12 Nov 2019 (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 evaluate the dosimetry, safety and the detection rate of 68Ga-THP-PSMA PET/CT for identifying the site of prostate cancer metastasis and relapse. It is also to evaluate the association of clinical/pathologic features and 68Ga-THP-PSMA PET/CT detection rate and compare 68Ga-THP-PSMA PET/CT with other imaging procedure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Drug: 68Ga-Labeled PSMA, Drug: Non-labeled PSMAAll Prostate cancer patients recruited to the study will be administered 2.11 MBq/kg of 68Ga-THP-PSMA in a single dose injection. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult male, age 18 years or older
- Prior diagnosis of prostatic cancer
- Willing to participate in this study and given written informed consent
- AST, ALT, BUN, Cr not more than double the normal values
- Subjects of childbearing potential must be willing to undergo a pregnancy test prior to enrolment
Key exclusion criteria (8 listed)
- Subjects with pacemakers
- Hepatitis B virus infection (including carriers) at screening, i.e. hepatitis B surface antigen (HBsAg) positive, or hepatitis C antibody (anti-HCV) positive, or acquired immunodeficiency disease (HIV) infected, or serum syphilis positive person
- Abnormal liver function during baseline screening period: AST or ALT> 2 times the upper limit of normal value (ULN), if the marginal increase of a single index is judged as having no clinical significance by the investigator, it can be retested during the screening period. Once, if more than 2 times ULN after retesting, consider enrolling).
- Impaired renal function during screening: serum creatinine or urea nitrogen > 1.5 times ULN.
- Within 4 months prior to the baseline screening period, myocardial infarction or other cardiac events requiring hospitalization (unstable angina, etc.), cerebrovascular accident, transient ischemic attack, acute congestive Heart failure or severe arrhythmia (ventricular arrhythmia, atrioventricular block above II)
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 |
|---|---|---|
| 68Ga-Labeled PSMAAlso: 68Ga-THP-PSMAAll participants in the study will be injected with 68Ga-THP-PSMA at a dose of 2.11 MBq/kg in a single dose injection. | Drug | Experimental Arm |
| Non-labeled PSMAAlso: THP-PSMAPatient will be injected with microdose (<100 ug) of THP-PSMA | Drug | Experimental Arm |
Primary outcome
The maximal standard uptake value
Time frame: 2 years
The tumor SUVmax of patients will be measured using Region Of Interest.
The measurement of PSA
Time frame: 2 years
The PSA level (ng/mL) of patients will be tested by hemanalysis
68Ga-THP-PSMA PET/CT in prostate cancer: clinical stage and restage
Time frame: 2 years
Visual analysis will be carried out by 4 experienced nuclear medicine physicians to observe the uptake of 68Ga-THP-PSMA in prostate malignant lesions. A 4 point method will be used to interpret the scans for abnormalities. It is categorized as such: score 0, no abnormal increased uptake; score 1, low increased uptake; score 2, moderate increased uptake; score 3, high increased uptake. The lesion will be considered positive for malignancy if the score is 2 or higher.
3 secondary outcomes
The correlation analysis
Time frame: 2 years
The dosimetry assessment
Time frame: 2 years
The safety evaluation
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
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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.
Jinhua Zhao, PhD principal investigator
Department of Nuclear Medicine, Shanghai General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 68Ga-Labeled PSMA and Non-labeled PSMA in people with Prostate Cancer, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 18 Apr 2023. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The maximal standard uptake value (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2023.