Prostate CancerNCT06054789
Clinical Study on 68Ga-PSMA-33 for PET/CT Imaging of Prostate Cancer
A study testing 68Ga-PSMA-33 in people with Prostate Cancer, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
The purpose of this study is to determine the pharmacokinetics, dosimetry, tolerance, tumor detection rate of 68Ga-PSMA-33 in patient with Prostate Cancer (PCa). Read more about this study
- Who is it for?
- Ages 18 to 99 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- 68Ga-PSMA-33
- 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 Oct 2022to 1 Oct 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 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male sex
- Age 18 years or older
- Patients must have histologically or cytologically confirmed localized or metastatic prostate cancer
- Creatinine less than or equal to 1.5 X upper limit of normal
- ECOG performance status 0 - 2, inclusive
- Able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine (or prone) for up to 30 minutes and tolerating intravenous cannulation Patient with complete clinical data.
- The effects of 68Ga-PSMA-33 on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
- Able to understand and provide written informed consent
Who cannot join
- Patient age < 18 years
- Received radioisotope diagnosis or treatment before enrollment, and the time window did not exceed 10 physical half-lives
- Malignancy other than current disease under study
- Patient simultaneously participating in another clinical trial
- Patient who cannot stay on PET/CT
- Patient with HIV, HCV, HVB infection or other serious chronic infection
Show all 9Show fewer
- Patient with liver and kidney function (GFR less than 50 ml/min) disease
- Cannot receive furosemide, allergy to sulfa or sulfa-containing medications
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
68Ga-PSMA-33 PET/CT imaging
Nanjing, Jiangsu, 210006
Wenyu Wu, 02552271276, 15150513147@163.com
About this study
The purpose of this study is to determine the pharmacokinetics, dosimetry, tolerance, tumor detection rate of 68Ga-PSMA-33 in patient with Prostate Cancer (PCa).
Read the detailed description
This study is design to prospectively investigate the safety and efficacy of 68Ga-PSMA-33 in the early diagnosis of Prostate Cancer (PCa). The specific objectives are the determination of pharmacokinetics, dosimetry, tolerance and tumor detection rate of 68Ga-PSMA-33 in patient with PCa. While PSMA is expressed at low levels in normal prostate epithelium, it is overexpressed (up to 1000 times higher) in 90-95% of prostate cancers, make PSMA an attractive target for the diagnosis and treatment of PCa. 68Ga-PSMA-33 as a new PSMA targeted probe was prepared and showed good uptake on PCa cell line and animal studies.
The study intends to recruit 8 PCa volunteers to participate in the experiment. All patients were intravenously injected with 68Ga-PSMA-33 and underwent PET/CT at 0.5, 1, 2 and 4 h, respectively. For comparison, 3 patients were additionally received 68Ga-PSMA-617 PET/CT imaging. The images were interpreted by two experienced physician and the SUVmax or SUVmean of physiological organs and tumor lesions were collected.
- Conditions
- Prostate Cancer
- Being tested
- 68Ga-PSMA-33
- Keywords
- Prostate-Specific Membrane Antigen (PSMA), PET/CT, Prostate cancer
- 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-PSMA-33Drug
Also called 68Ga-PSMA-617
Subjects will receive one injection of 68Ga-PSMA-33/PSMA-617 (3-7mCi ), a PET radiopharmaceutical selective for Prostate-Specific Membrane Antigen. 68Ga-PSMA-33/PSMA-617 injection will be followed by a 10 ml saline flush.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-PSMA-33 | Experimental | For the injection, subjects will receive a target dose of 3-7mCi 68Ga-PSMA-33 as a bolus injection. Among them, 3~4 subjects will additionally inject with 68Ga-PSMA-617 (3-7mCi). Receives: Drug: 68Ga-PSMA-33 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor detection rate
Comparing the number of tumor detected by 68Ga-PSMA-33 and 68Ga-PSMA-617 PET/CT.
Measured: 2 years
Standardized uptake value (SUV) of tumor
Comparing the SUVmax of tumor derived from 68Ga-PSMA-33 and 68Ga-PSMA-617 PET/CT.
Measured: 2 years
Secondary outcomes (1)
Safety and Tolerability Profile Measured by Adverse Events (AEs)
Safety and tolerability profile for the administration of 68Ga-PSMA-33 and positron emission tomography (PET) scanning are measured by number of participants with adverse events (AEs).
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 posted26 Sep 2023
- Study start1 Oct 2022
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Oct 2024 (estimated)
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 Nanjing First Hospital, Nanjing Medical UniversityThe 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
- 8 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FengWang, Nanjing First Hospital, Nanjing Medical University
- Investigators
- Feng Wang, Study director, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054789
- Sponsor's protocol ID
- 68Ga-PSMA-33
- Status last verified
- Sep 2023
- First submitted
- 12 Sep 2023
- Last updated
- 26 Sep 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 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on 68Ga-PSMA-33 for PET/CT Imaging of Prostate Cancer
- ClinicalTrials.gov ID
- NCT06054789
- Acronym / sponsor ID
- 68Ga-PSMA-33
- Conditions
- Prostate Cancer
- Keywords
- Prostate-Specific Membrane Antigen (PSMA), PET/CT, Prostate cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 26 Sep 2023 (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.
The purpose of this study is to determine the pharmacokinetics, dosimetry, tolerance, tumor detection rate of 68Ga-PSMA-33 in patient with Prostate Cancer (PCa).
Detailed description
This study is design to prospectively investigate the safety and efficacy of 68Ga-PSMA-33 in the early diagnosis of Prostate Cancer (PCa). The specific objectives are the determination of pharmacokinetics, dosimetry, tolerance and tumor detection rate of 68Ga-PSMA-33 in patient with PCa. While PSMA is expressed at low levels in normal prostate epithelium, it is overexpressed (up to 1000 times higher) in 90-95% of prostate cancers, make PSMA an attractive target for the diagnosis and treatment of PCa. 68Ga-PSMA-33 as a new PSMA targeted probe was prepared and showed good uptake on PCa cell line and animal studies.
The study intends to recruit 8 PCa volunteers to participate in the experiment. All patients were intravenously injected with 68Ga-PSMA-33 and underwent PET/CT at 0.5, 1, 2 and 4 h, respectively. For comparison, 3 patients were additionally received 68Ga-PSMA-617 PET/CT imaging. The images were interpreted by two experienced physician and the SUVmax or SUVmean of physiological organs and tumor lesions were collected.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-PSMA-33 | Experimental | Drug: 68Ga-PSMA-33For the injection, subjects will receive a target dose of 3-7mCi 68Ga-PSMA-33 as a bolus injection. Among them, 3~4 subjects will additionally inject with 68Ga-PSMA-617 (3-7mCi). |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male sex
- Age 18 years or older
- Patients must have histologically or cytologically confirmed localized or metastatic prostate cancer
- Creatinine less than or equal to 1.5 X upper limit of normal
- ECOG performance status 0 - 2, inclusive
Key exclusion criteria (9 listed)
- Patient age < 18 years
- Received radioisotope diagnosis or treatment before enrollment, and the time window did not exceed 10 physical half-lives
- Malignancy other than current disease under study
- Patient simultaneously participating in another clinical trial
- Patient who cannot stay on PET/CT
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-PSMA-33Also: 68Ga-PSMA-617Subjects will receive one injection of 68Ga-PSMA-33/PSMA-617 (3-7mCi ), a PET radiopharmaceutical selective for Prostate-Specific Membrane Antigen. 68Ga-PSMA-33/PSMA-617 injection will be followed by a 10 ml saline flush. | Drug | 68Ga-PSMA-33 |
Primary outcome
Tumor detection rate
Time frame: 2 years
Comparing the number of tumor detected by 68Ga-PSMA-33 and 68Ga-PSMA-617 PET/CT.
Standardized uptake value (SUV) of tumor
Time frame: 2 years
Comparing the SUVmax of tumor derived from 68Ga-PSMA-33 and 68Ga-PSMA-617 PET/CT.
1 secondary outcome
Safety and Tolerability Profile Measured by Adverse Events (AEs)
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 26 Sep 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.
Feng Wang study director
Nanjing First Hospital, Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 68Ga-PSMA-33 in people with Prostate Cancer, run by Nanjing First Hospital, Nanjing Medical University 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 8 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 26 Sep 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.
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 Feng Wang (02552271276, fengwangcn@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor detection rate (time frame: 2 years). The study lists 2 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 26 Sep 2023.