Prostate CancerNCT05422105
Diagnostic Performance of 18F-PSMA-1007 PET/CT in Suspected Prostate Cancer Patient
An observational study of Prostate Cancer and Prostate Neoplasm, run by Primo Biotechnology Co., Ltd at 2 sites in Taiwan.
Trial summary
The diagnostic tools for detecting patients with early prostate cancer are limited due to poor diagnostic performance. The positron emission tomography (PET) combination with the diagnostic radiopharmacy is a non-invasive tool to provide the molecular imaging of the whole body and offer more comprehensive… Read more about this study
- Who is it for?
- Ages 20 to 100 years, men only
- Conditions the study is for
- Prostate Cancer, Prostate Neoplasm
- What is being tested?
- 18F-PSMA-1007
- How many people
- 230 participants
- Where
- 2 sitesTaiwan
- Study dates
- 1 Jul 2023to 31 Dec 2026
- Phase
- Observational
- 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 20 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: The patients with suspected prostate cancer had a serum PSA value between 4 and 20 ng/ml or a serum PSA value of < 4ng/ml but noted abnormal lesions by digital rectal examination.
Who may be able to join
- The participants are male adults over 20 years old.
- The participants are suspected prostate cancer patients by a serum PSA value of 4-20 ng/ml or a serum PSA value of < 4ng/ml but noted abnormal lesion by DRE.
- The participants agree to receive TRUS Bx or mpMRI fusion Bx examination.
- The participants are the first time to receive a prostatic biopsy.
Who cannot join
- The participants are diagnosed with prostate cancer before this study.
- The participants have received any related treatment for prostate cancer.
- The participants have chronic prostatitis.
- The participants' serum hemoglobin lowers than 10 mg/dl within 1 month.
- The participants' serum platelet lowers than 15 103/uL within 1 month.
- The participants' serum prothrombin time (PT) is prolonged longer than 1.2-fold within 1 month.
Show all 19Show fewer
- The participants' serum active partial prothrombin time (aPPT) is prolonged longer than 45 seconds within 1 month.
- The participants have hemorrhagic disease such as Hemophilia, Von Willebrand disease, thrombocytopenia, systemic Lupus Erythematosus, etc. within 6 months.
- The participants have conditions of poor immunity status such as HIV infection, receiving treatment for other cancer, DM poor control, use of immunomodulator (ex.
- steroid, etc.) within 6 months.
- The participants have hypertension poor control that is BP cannot be controlled lower than 140/90mmHg whether or not taking medication within 6 months.
- The participants have suffered from CVA including infarctions and hemorrhages within 6 months.
- The participants have suffered from angina including stable and unstable types within 6 months.
- The participants have suffered from arrythmia poor control within 6 months.
- The participants have suffered from liver dysfunction such as AST/ALT ratio >2、total bilirubin >1.5 mg/dL within 6 months.
- The participants are allergic to any radiopharmaceutical or imaging agent.
- The participants suffered stage IV chronic kidney disease (eGFR<30 mL/min/1.73 m2) within 6 months
- The participants suffered acute kidney injury within 6 months.
- The participants are absolute and relative contraindications to MRI examination.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Tungs'Taichung Metro Harbor Hospital
Taichung, 43503
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, 111
About this study
Official title: Multicenter Evaluation of Diagnostic Performance of [18F]FPSMA-1007 PET/CT in Patients With Suspected Prostate Cancer
The diagnostic tools for detecting patients with early prostate cancer are limited due to poor diagnostic performance. The positron emission tomography (PET) combination with the diagnostic radiopharmacy is a non-invasive tool to provide the molecular imaging of the whole body and offer more comprehensive physiological information and then can raise the diagnostic performance. Prostate-specific membrane antigen (PSMA)-targeting pharmaceuticals have been regarded as the most promising diagnostic tool to diagnose patients with prostate cancer. Currently, the 18F-PSMA-1007 as PSMA-targeting 18F-radiolabeled pharmaceuticals have developed and successfully used in patients with intermittent- and high-risk prostate cancer or recurrent prostate cancer. The study aims to understand the diagnostic performance of 18F-PSMA-1007 PET/CT in different-stage prostate cancer patients by initiating the first multicenter clinical trial of 18F-PSMA-1007 in Taiwan.
- Conditions
- Prostate Cancer, Prostate Neoplasm
- Being tested
- 18F-PSMA-1007
- Keywords
- Prostate cancer, [18F]FPSMA-1007, mpMRI
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-PSMA-1007Drug
Also called [18F]FPSMA-1007
18F-PSMA-1007 PET/CT
| Study group | Role | What they receive |
|---|---|---|
| Suspected Prostate Cancer | Not described Receives: Drug: 18F-PSMA-1007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Performance
Sensitivity, Specificity, NPV, PPV
Measured: 7-14 days after PET/CT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start1 Jul 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Why it stopped: Interim Analysis
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.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Primo Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ABX advanced biochemical compounds GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05422105
- Sponsor's protocol ID
- PB01-MCTNSPC
- Status last verified
- Jun 2026
- First submitted
- 14 Jun 2022
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Evaluation of Diagnostic Performance of [18F]FPSMA-1007 PET/CT in Patients With Suspected Prostate Cancer
- ClinicalTrials.gov ID
- NCT05422105
- Acronym / sponsor ID
- PB01-MCTNSPC
- Conditions
- Prostate Cancer, Prostate Neoplasm
- Keywords
- Prostate cancer, [18F]FPSMA-1007, mpMRI
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Interim Analysis
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Primo Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- ABX advanced biochemical compounds GmbH
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Jun 2022 (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 diagnostic tools for detecting patients with early prostate cancer are limited due to poor diagnostic performance. The positron emission tomography (PET) combination with the diagnostic radiopharmacy is a non-invasive tool to provide the molecular imaging of the whole body and offer more comprehensive physiological information and then can raise the diagnostic performance. Prostate-specific membrane antigen (PSMA)-targeting pharmaceuticals have been regarded as the most promising diagnostic tool to diagnose patients with prostate cancer. Currently, the 18F-PSMA-1007 as PSMA-targeting 18F-radiolabeled pharmaceuticals have developed and successfully used in patients with intermittent- and high-risk prostate cancer or recurrent prostate cancer. The study aims to understand the diagnostic performance of 18F-PSMA-1007 PET/CT in different-stage prostate cancer patients by initiating the first multicenter clinical trial of 18F-PSMA-1007 in Taiwan.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspected Prostate Cancer | – | Drug: 18F-PSMA-1007 |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients with suspected prostate cancer had a serum PSA value between 4 and 20 ng/ml or a serum PSA value of < 4ng/ml but noted abnormal lesions by digital rectal examination.
Key inclusion criteria (4 listed)
- The participants are male adults over 20 years old.
- The participants are suspected prostate cancer patients by a serum PSA value of 4-20 ng/ml or a serum PSA value of < 4ng/ml but noted abnormal lesion by DRE.
- The participants agree to receive TRUS Bx or mpMRI fusion Bx examination.
- The participants are the first time to receive a prostatic biopsy.
Key exclusion criteria (19 listed)
- The participants are diagnosed with prostate cancer before this study.
- The participants have received any related treatment for prostate cancer.
- The participants have chronic prostatitis.
- The participants' serum hemoglobin lowers than 10 mg/dl within 1 month.
- The participants' serum platelet lowers than 15 103/uL within 1 month.
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 |
|---|---|---|
| 18F-PSMA-1007Also: [18F]FPSMA-100718F-PSMA-1007 PET/CT | Drug | Suspected Prostate Cancer |
Primary outcome
Diagnostic Performance
Time frame: 7-14 days after PET/CT
Sensitivity, Specificity, NPV, PPV
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Prostate Neoplasm, run by Primo Biotechnology Co., Ltd at 2 sites in Taiwan.
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 4 inclusion and 19 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: paused, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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?
Diagnostic Performance (time frame: 7-14 days after PET/CT). 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 6 Jul 2026.