Prostate Adenocarcinoma With Focal Neuroendocrine DifferentiationEarly Phase 1NCT07886138

RET-Targeted Molecular Imaging Probes in Prostate Cancer

A Early Phase 1 study testing RET-targeted PET/CT molecular imaging and PSMA-targeted PET/CT imaging in people with Prostate Adenocarcinoma With Focal Neuroendocrine Differentiation and Prostate Cancer, run by Xiangya Hospital of Central South University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 45 to 80 years, men onlyHealthy volunteers can take part
Conditions the study is for: Prostate Adenocarcinoma With Focal Neuroendocrine Differentiation, Prostate Cancer
What is being tested?: RET-targeted PET/CT molecular imaging and PSMA-targeted PET/CT imaging
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteChina
Study dates: 3 Apr 2026to 3 Apr 2027
Phase: Early Phase 1

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 45 to 80 years
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male patients aged 45-80 years.
Diagnosed with conventional prostatic adenocarcinoma or neuroendocrine prostate cancer (NEPC) by clinical data, serum markers, and pathology (biopsy); patients with no other neuroendocrine tumors or related diseases and no history of acute infection or acute trauma.
Patients with newly diagnosed disease will be enrolled before receiving specific treatment (ADT, chemotherapy, second-generation androgen receptor inhibitors, etc.) whenever possible; patients with recurrent disease will be enrolled as soon as possible.
Able to cooperate in the observation of adverse events and efficacy.
Patients with suspected NEPC based on positive serum neuroendocrine markers (SYP/CHGA/NSE), or confirmed NEPC by biopsy histopathology with positive neuroendocrine marker immunohistochemistry (SYP/CHGA/NSE).
Capable of undergoing pathological examination to confirm the diagnosis; willing to provide informed consent and able to accept follow-up.
The patient or his legally authorized representative signs the written informed consent form.

Who cannot join

Patients without prostate cancer.
Fever with body temperature above 38°C or clinically evident active infection that could affect the trial.
Cardiac, pulmonary, hepatic, or renal function assessed as unsuitable for the examination (e.g., organic heart disease or arrhythmia; abnormal pulmonary function such as FVC, FEV1, FEV1/FVC, DLCO, or DLCO/VA outside the normal range with ventilatory disorders; abnormal liver function with AST, ALT, or ALP more than 1 times the upper limit of the reference range; total/direct bilirubin above normal or total protein, albumin, and globulin below normal; abnormal renal function such as hematuria or proteinuria, or creatinine, urea, or uric acid above normal values).
Uncontrolled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg).
Abnormal coagulation function (PET/CT involves venous injection; normal coagulation must be ensured).
Significant cardiovascular abnormalities (e.g., myocardial infarction, superior vena cava syndrome, grade 2 or higher heart disease before enrollment, or heart disease that increases the risk of ventricular arrhythmia as judged by the investigator).

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History of arrhythmia (multifocal ventricular premature beats, bigeminy, trigeminy, or congenital long QT syndrome).
Tachycardia or uncontrolled atrial fibrillation, symptomatic or requiring treatment (CTCAE grade 3), or asymptomatic sustained tachycardia.
Presence of left bundle branch block.
Third-degree atrioventricular block or symptomatic sick sinus syndrome.
Patients who cannot complete the PET examination due to disease progression.
Patients too ill to undergo further evaluation and treatment.

Trial locations and contacts

1 site in 1 country.

China1 site

Xiangya Hospital of Central South University
Changsha, Hunan, 410008

Other trials in China

About this study

The goal of this observational diagnostic imaging study is to evaluate the value of RET-targeted PET/CT molecular imaging in diagnosing neuroendocrine prostate cancer (NEPC) and in assessing disease activity, treatment response, and prognosis. The study population consists of men aged 45-80 years, including approximately 40 patients with suspected or confirmed NEPC (positive group) and approximately 10 patients with conventional prostatic adenocarcinoma (negative control group).

The main questions it aims to answer are:

Can RET-targeted PET/CT imaging accurately diagnose neuroendocrine prostate cancer, using pathology as the gold standard? Compared with PSMA PET/CT, multiparametric MRI (mpMRI), and serum markers, does RET-targeted PET/CT provide better diagnostic performance (sensitivity, specificity, positive and negative predictive values)? Is the level of RET tracer uptake in lesions associated with disease progression and prognosis, and can it be used for early assessment of treatment response? Researchers will compare RET-PET/CT imaging results against pathology (the primary reference standard), PSMA PET/CT, conventional contrast-enhanced MRI, and serum markers to determine the diagnostic advantage of RET-targeted imaging.

Participants will:

Sign a written informed consent form; Undergo whole-body PET/CT (and if needed, PET/MRI) imaging with RET- and PSMA-targeted tracers (approximately 0.15 mCi/kg injected intravenously; if a repeat scan is needed due to disease changes, it will be performed at least 1 week apart); Have blood pressure, pulse, respiration, and temperature measured before and after imaging, and liver/kidney function tests and routine blood and urine tests performed one day before and after imaging; Undergo multiparametric MRI (mpMRI); Be followed up, with any clinical symptoms or signs of discomfort during and up to two weeks after imaging recorded in detail.

Conditions: Prostate Adenocarcinoma With Focal Neuroendocrine Differentiation, Prostate Cancer
Being tested: RET-targeted PET/CT molecular imaging, PSMA-targeted PET/CT imaging
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RET-targeted PET/CT molecular imagingDiagnostic test
Participants receive an intravenous injection of a RET-targeted PET tracer (approximately 0.15 mCi/kg, nanomolar tracer dose, radiochemical purity >95%) prepared and quality-controlled at the investigators' PET center. After resting in a dark room for 5-10 or 45-60 minutes and voiding, whole-body PET/CT (or PET/MRI for head and spine) imaging is performed with an emission scan time of 10-20 minutes. PET images are reconstructed by OSEM. Two experienced nuclear medicine physicians review the images; a lesion with tracer uptake higher than surrounding or contralateral normal tissue is considered positive, and SUVmax, SUVmean, and lesion size are measured by ROI analysis. If disease changes require a repeat scan, it is performed at least 1 week apart.
PSMA-targeted PET/CT imagingDiagnostic test
Participants undergo whole-body PET/CT (or PET/MRI) imaging with a PSMA-targeted tracer (approximately 0.15 mCi/kg injected intravenously) using the same scanner, protocol, image reconstruction, and image analysis procedures as the RET-targeted imaging. PSMA imaging serves as the comparator to evaluate the diagnostic performance of RET-targeted imaging.

Study groups in NCT07886138
Study group	Role	What they receive
RET-Targeted PET/CT Imaging in Neuroendocrine Prostate Cancer (NEPC) Patients	Experimental	Patients with suspected or confirmed neuroendocrine prostate cancer (NEPC) will undergo whole-body PET/CT imaging with a RET-targeted tracer and a PSMA-targeted tracer (approximately 0.15 mCi/kg injected intravenously). Imaging findings will be compared with pathology (the gold standard), serum neuroendocrine markers, and clinical follow-up to evaluate diagnostic performance, treatment response, and prognosis. Receives: Diagnostic Test: RET-targeted PET/CT molecular imaging; Diagnostic Test: PSMA-targeted PET/CT imaging
Control: PET/CT Imaging in Conventional Prostatic Adenocarcinoma Patients	Experimental	Patients with conventional prostatic adenocarcinoma (control group) will undergo the same imaging procedures as the NEPC group: whole-body PET/CT (or PET/MRI) with a RET-targeted tracer and a PSMA-targeted tracer (approximately 0.15 mCi/kg intravenously), plus multiparametric MRI (mpMRI), to serve as the negative control for evaluating the specificity of RET-targeted imaging. Receives: Diagnostic Test: RET-targeted PET/CT molecular imaging; Diagnostic Test: PSMA-targeted PET/CT imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

Diagnostic accuracy of RET-targeted PET/CT for neuroendocrine prostate cancer (NEPC)
The diagnostic performance of RET-targeted PET/CT for NEPC will be evaluated against pathology (the gold standard, based on biopsy or surgical specimen with neuroendocrine marker immunohistochemistry: SYP/CHGA/NSE). Diagnostic accuracy parameters, including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), will be calculated.
Measured: At the time of imaging, with pathology confirmation within approximately 1 month after imaging

Secondary outcomes (4)

Comparison of diagnostic performance between RET-PET/CT and PSMA PET/CT
Sensitivity, specificity, PPV, and NPV of RET-targeted PET/CT will be compared with those of PSMA PET/CT, and serum neuroendocrine markers to determine the diagnostic advantage of RET-targeted imaging.
Measured: At the time of imaging
Semi-quantitative tracer uptake (SUVmax and SUVmean) of lesions on RET-targeted PET/CT
The region of interest (ROI) with the highest tracer uptake in each lesion will be delineated, and SUVmax, SUVmean, and lesion size will be measured and compared between groups using independent-samples and paired t-tests.
Measured: At the time of imaging
Correlation between lesion SUVmax on RET-targeted PET/CT and disease progression
The correlation between the semi-quantitative RET tracer uptake of lesions, measured as SUVmax (unitless ratio) by region-of-interest analysis on RET-targeted PET/CT, and disease progression will be assessed. Disease progression will be determined by clinical evaluation and conventional imaging (PSMA PET/CT, mpMRI) according to clinical criteria, and progression-free survival will be recorded in months. Multivariable analysis (e.g., Cox proportional hazards regression) will be used to evaluate the relationship between baseline SUVmax and time to disease progression or death.
Measured: Up to 5 years after enrollment
Value of RET-targeted PET/CT for early assessment of treatment response
Changes in RET tracer uptake will be analyzed in relation to clinical disease progression and compared with pathology, serum markers, and other imaging findings to evaluate the value of RET-targeted PET/CT for early treatment response assessment.
Measured: During follow-up after treatment (repeat imaging at least 1 week apart when needed)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Apr 20263 Apr 2027

First posted21 Oct 2026
Study start3 Apr 2026
Primary completion3 Apr 2027 (estimated)
Study completion3 Apr 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Prostate Adenocarcinoma With Focal Neuroendocrine DifferentiationStudies 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: Early Phase 1
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 50 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07886138
Sponsor's protocol ID: 202601018
Status last verified: Apr 2026
First submitted: 9 Oct 2026
Last updated: 21 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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