Prostate Cancer (Adenocarcinoma)Phase 2NCT07209865
68Ga-P16-093 PET Imaging for Diagnosing Prostate Cancer, a Head-to-head Comparison With mpMRI
A Phase 2 study testing 68Ga-P16-093 in people with Prostate Cancer (Adenocarcinoma), run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
Trial summary
68Ga-P16-093 is a novel radiotracer targeting PSMA. In this study, we investigated the diagnostic efficacy of 68Ga-P16-093 PET imaging (PET/CT or PET/MRI) in patients with newly diagnosed, treatment-naive prostate cancer, and performed a head-to-head comparison with multi-parameter magnetic resonance imaging (mpMRI). Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer (Adenocarcinoma)
- What is being tested?
- 68Ga-P16-093
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 20 Jun 2026
- Phase
- Phase 2
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 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy-confirmed adenocarcinoma of the prostate.
- No anti-tumor treatment received prior to the PET imaging.
- Subjects provide signed informed consent and confirm that they are able and willing to comply with all protocol requirements.
- Radical prostatectomy scheduled within 28 days after PET imaging.
Who cannot join
- Patients with other malignant tumors
- Subjects with any medical condition or other circumstance that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completion.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
About this study
Official title: 68Ga-P16-093 PET Imaging in the Diagnostic Study of Newly Diagnosed, Untreated Prostate Cancer, With a Head-to-head Comparison to mpMRI, a Phase 2 Clinical Trial
68Ga-P16-093 is a novel radiotracer targeting PSMA. In this study, we investigated the diagnostic efficacy of 68Ga-P16-093 PET imaging (PET/CT or PET/MRI) in patients with newly diagnosed, treatment-naive prostate cancer, and performed a head-to-head comparison with multi-parameter magnetic resonance imaging (mpMRI).
Read the detailed description
68Ga-P16-093 is a novel radiotracer targeting PSMA. Previously, we conducted multiple studies confirming the clinical application of 68Ga-P16-093 PET/CT. However, multi-parametric magnetic resonance imaging (mpMRI) still holds a dominant position in the imaging diagnosis of prostate cancer. In this study, we will further evaluate the diagnostic performance of 68Ga-P16-093 positron emission tomography (PET/CT or PET/MRI) in newly diagnosed and untreated prostate cancer patients, with a head-to-head comparison to mpMRI.
- Conditions
- Prostate Cancer (Adenocarcinoma)
- Being tested
- 68Ga-P16-093
- Keywords
- PSMA, Prostate cancer, PET imaging, mpMRI
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-P16-093Drug
Intravenous injection of Ga-P16-093 with a dosage of 111-148 MBq (3-4 mCi), followed by PET/CT plus PET/MRI acquisition according to standard methods.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-P16-093 PET imaging | Experimental | Intravenous injection of 68Ga-P16-093 with a dosage of 111-148 MBq (3-4 mCi), followed by PET/CT plus PET/MRI acquisition according to standard methods. Receives: Drug: 68Ga-P16-093 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of 68Ga-P16-093 PET Imaging to Detect Intraprostatic Tumors Relative to Histopathology in newly diagnosed, treatment-naive Prostate Cacner Participants
Using histopathology from radical prostatectomy as the reference standard, validate the true positive detection rate of PET for prostate lesions. Two experienced nuclear medicine physicians, blinded to all other imaging and clinical history of the patients, independently assessed the PET images. Any disagreements were resolved by consensus.
Measured: Within 28 days of imaging, radical prostatectomy will occur.
Specificity of 68Ga-P16-093 PET Imaging to Detect Intraprostatic Tumors Relative to Histopathology in newly diagnosed, treatment-naive Prostate Cacner Participants
Using histopathology from radical prostatectomy as the reference standard, validate the true negative detection rate of PET for prostate lesions. Two experienced nuclear medicine physicians, blinded to all other imaging and clinical history of the patients, independently assessed the PET images. Any disagreements were resolved by consensus.
Measured: Within 28 days of imaging, radical prostatectomy will occur.
Secondary outcomes (1)
Comparison of Detection Rates for Intraprostatic Tumors Between 68Ga-P16-093 PET Imaging and mpMRI
The number of intraprostatic lesions detected on imaging will be determined by each of independent readers. The sum of lesions per participant per tissue type and overall will be computed for each participant based on each reader's lesion count. This will be calculated from the 68Ga-P16-093 PET scan results as well as the mpMRI results.
Measured: Within 1-2 hours of 68Ga-P16-093 dosing, a whole body PET scan will be taken
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start1 Oct 2024
- Primary completion31 Dec 2025
- Study completion20 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Adenocarcinoma)Studies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weibing Miao, MD, Principal investigator, First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07209865
- Sponsor's protocol ID
- FirstAHFujian-68Ga-P16-093
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No