Prostate CancerEarly Phase 1NCT05955677
Head-to-head Comparison of [68Ga]Ga-PSMA-D5 With [68Ga]Ga-PSMA-11 PET/CT in PCa Diagnosis, Recurrence, and Metastasis
A Early Phase 1 study testing [68Ga]Ga-PSMA-D5 and [68Ga]Ga-PSMA-11 in people with Prostate Cancer and PET/CT, run by Anhui Provincial Hospital at 1 site in China.
Trial summary
To prospectively evaluate the radiodrug biodistribution of a novel PET imaging agent [68Ga]Ga-PSMA-D5 in different organs of prostate cancer patients and its diagnostic efficacy in the diagnosis, recurrence and metastasis of prostate cancer, and to compare with [68Ga]Ga-PSMA-11. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer, PET/CT
- What is being tested?
- [68Ga]Ga-PSMA-D5 and [68Ga]Ga-PSMA-11
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2023to 31 Dec 2024
- 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 90 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged from 18 to 90 years old;
- Complete MRI images and clinical data (such as PSA level, Gleason grade, etc.);
- Prostate cancer detected by PSA or imaging examination, or clinically suspected recurrence after standardized treatment;
- simultaneous [68Ga]Ga-PSMA-D5 and [68Ga]Ga-PSMA-11 examinations within two weeks;
- Willing to undergo surgery or needle biopsy for pathological examination after examination, or confirmed as prostate cancer by histopathology before or after treatment;
- Sign informed consent.
Who cannot join
- Patients who cannot cooperate with the examination;
- Concurrent malignant tumors;
- Previous alcohol allergy;
- Patients with liver and kidney dysfunction;
- Other circumstances deemed by the investigator to be inappropriate for trial participation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of China University of Science and Technology（Anhui Provincial Hospital）
Hefei, Anhui, 230000
Qiang Xie, MD, +8613721108043, xieqiang1980@ustc.edu.cn
About this study
Official title: Head-to-head Comparison of [68Ga]Ga-PSMA-D5 With [68Ga]Ga-PSMA-11 PET/CT in Prostate Cancer Diagnosis, Recurrence, and Metastasis: a Prospective Study
To prospectively evaluate the radiodrug biodistribution of a novel PET imaging agent [68Ga]Ga-PSMA-D5 in different organs of prostate cancer patients and its diagnostic efficacy in the diagnosis, recurrence and metastasis of prostate cancer, and to compare with [68Ga]Ga-PSMA-11.
Read the detailed description
[68Ga]Ga-PSMA-D5 PET/CT was used for initial assessment of prostate cancer or detection of recurrence. The maximum standardized uptake value (SUVmax) was used to evaluate tumor uptake. The sensitivity, specificity, the number and accuracy of lesions identified and the distribution of lesions in each organ were calculated and compared with those of [68Ga]Ga-PSMA-11 PET/CT.
- Conditions
- Prostate Cancer, PET/CT
- Being tested
- [68Ga]Ga-PSMA-D5, [68Ga]Ga-PSMA-11
- 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]Ga-PSMA-D5Drug
Also called [68Ga]Ga-PSMA-D5 injection
Each subject receive a single intravenous injection of [68Ga]Ga-PSMA-D5, and undergo PET/CT imaging within the specificed time.
[68Ga]Ga-PSMA-11Drug
Also called [68Ga]Ga-PSMA-11 injection
Each subject receive a single intravenous injection of [68Ga]Ga-PSMA-11, and undergo PET/CT imaging within the specificed time.
| Study group | Role | What they receive |
|---|---|---|
| [68Ga]Ga-PSMA-D5 and [68Ga]Ga-PSMA-11 PET/ CT scan | Experimental | Subjects PET/CT imaging: On any two days for two consecutive weeks, each subject underwent a PET/ CT scan after intravenous injection of [68Ga]Ga-PSMA-D5 and [68Ga]Ga-PSMA-11. Receives: Drug: [68Ga]Ga-PSMA-D5; Drug: [68Ga]Ga-PSMA-11 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard uptake value(SUV)
Standard uptake value(SUV) of [68Ga]Ga-PSMA-D5 and [68Ga]Ga-PSMA-11 for each target lesion of subjects.
Measured: 30 days
Secondary outcomes (2)
Diagnostic efficacy
The sensitivity, specificity and accuracy of [68Ga]Ga-PSMA-D5 and [68Ga]Ga-PSMA-11 PET/CT were calculated.
Measured: 30 days
Number of lesions
The number of lesions detected by [68Ga]Ga-PSMA-D5 and [68Ga]Ga-PSMA-11 PET/CT.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start10 Jul 2023
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Dec 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 Anhui Provincial 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Qiang Xie, Study chair, The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05955677
- Sponsor's protocol ID
- First D5
- Status last verified
- Jul 2023
- First submitted
- 10 Jul 2023
- Last updated
- 21 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head-to-head Comparison of [68Ga]Ga-PSMA-D5 With [68Ga]Ga-PSMA-11 PET/CT in Prostate Cancer Diagnosis, Recurrence, and Metastasis: a Prospective Study
- ClinicalTrials.gov ID
- NCT05955677
- Acronym / sponsor ID
- First D5
- Conditions
- Prostate Cancer, PET/CT
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Jul 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.
To prospectively evaluate the radiodrug biodistribution of a novel PET imaging agent [68Ga]Ga-PSMA-D5 in different organs of prostate cancer patients and its diagnostic efficacy in the diagnosis, recurrence and metastasis of prostate cancer, and to compare with [68Ga]Ga-PSMA-11.
Detailed description
[68Ga]Ga-PSMA-D5 PET/CT was used for initial assessment of prostate cancer or detection of recurrence. The maximum standardized uptake value (SUVmax) was used to evaluate tumor uptake. The sensitivity, specificity, the number and accuracy of lesions identified and the distribution of lesions in each organ were calculated and compared with those of [68Ga]Ga-PSMA-11 PET/CT.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [68Ga]Ga-PSMA-D5 and [68Ga]Ga-PSMA-11 PET/ CT scan | Experimental | Drug: [68Ga]Ga-PSMA-D5, Drug: [68Ga]Ga-PSMA-11Subjects PET/CT imaging: On any two days for two consecutive weeks, each subject underwent a PET/ CT scan after intravenous injection of [68Ga]Ga-PSMA-D5 and [68Ga]Ga-PSMA-11. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged from 18 to 90 years old;
- Complete MRI images and clinical data (such as PSA level, Gleason grade, etc.);
- Prostate cancer detected by PSA or imaging examination, or clinically suspected recurrence after standardized treatment;
- simultaneous [68Ga]Ga-PSMA-D5 and [68Ga]Ga-PSMA-11 examinations within two weeks;
- Willing to undergo surgery or needle biopsy for pathological examination after examination, or confirmed as prostate cancer by histopathology before or after treatment;
Key exclusion criteria (5 listed)
- Patients who cannot cooperate with the examination;
- Concurrent malignant tumors;
- Previous alcohol allergy;
- Patients with liver and kidney dysfunction;
- Other circumstances deemed by the investigator to be inappropriate for trial participation.
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]Ga-PSMA-D5Also: [68Ga]Ga-PSMA-D5 injectionEach subject receive a single intravenous injection of [68Ga]Ga-PSMA-D5, and undergo PET/CT imaging within the specificed time. | Drug | [68Ga]Ga-PSMA-D5 and [68Ga]Ga-PSMA-11 PET/ CT scan |
| [68Ga]Ga-PSMA-11Also: [68Ga]Ga-PSMA-11 injectionEach subject receive a single intravenous injection of [68Ga]Ga-PSMA-11, and undergo PET/CT imaging within the specificed time. | Drug | [68Ga]Ga-PSMA-D5 and [68Ga]Ga-PSMA-11 PET/ CT scan |
Primary outcome
Standard uptake value(SUV)
Time frame: 30 days
Standard uptake value(SUV) of [68Ga]Ga-PSMA-D5 and [68Ga]Ga-PSMA-11 for each target lesion of subjects.
2 secondary outcomes
Diagnostic efficacy
Time frame: 30 days
Number of lesions
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- 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.
Qiang Xie study chair
The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
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]Ga-PSMA-D5 and [68Ga]Ga-PSMA-11 in people with Prostate Cancer and PET/CT, run by Anhui Provincial 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 6 inclusion and 5 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 21 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qiang Xie, MD (+8613721108043, xieqiang1980@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standard uptake value(SUV) (time frame: 30 days). 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 21 Jul 2023.