An Early Phase 1 interventional study of 68Ga-Labeled EphA2/PSMA Dual-Target Radiotracer PET/CT imaging and 68Ga-Labeled ACP3/PSMA Dual-Target Radiotracer PET/CT imaging in Prostate Cancer, sponsored by The First Affiliated Hospital of Soochow University. Active, not recruiting at 1 site in China. Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by The First Affiliated Hospital of Soochow University · Early Phase 1, Interventional, and Diagnostic
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Among 541 studies in Prostatic Neoplasms with a site in China — 281 open to participants now, 342 under way, 51 of them phase 3. Prostatic Neoplasms · China.
Among the 541 studies in Prostatic Neoplasms with a site in China, this one is the 335th largest by planned enrollment of the 435 interventional ones that give a count, is one of 83 that started in 2026, is one of 97 in phase 1, reaches primary completion later than 266 of the 341 other live ones, and was the 541st registered.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,579 are open to participants now.
Browse Prostatic Neoplasms studies →281 of the 541 studies in Prostatic Neoplasms with a site in China are open now. Recruiting first, the newest first:
The First Affiliated Hospital of Xiamen University · Sites in China
Ages 18+ · Men only
TransThera Sciences (Nanjing), Inc. · Sites in China
Ages 18+ · Men only
Janssen Research & Development, LLC · Sites in China, United States, Australia and 1 more country
Ages 18+ · Men only
AstraZeneca · Sites in China, United States, Austria and 18 more countries
Ages 18+ · Men only
FindCure Biosciences (ZhongShan) Co., Ltd. · Sites in China
Ages 18+ · Men only
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 1,228 Prostatic Neoplasms studies recruiting now, 927 (75%) set no upper age limit and 76 (6%) stop at 75 or younger; 67 take children under 18; 82 take healthy volunteers.
This study: 18 Years to 80 Years · male · no healthy volunteers.
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541 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 149 · Phase 2 146 · Phase 3 87 · Phase 4 7
First in 2003; this study’s year is marked. 83 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 30 is below the median of 60 across 5,349 interventional studies indexed under Prostatic Neoplasms.
Median enrollment 100 across the 435 interventional studies, 300 across the 106 observational. Of the 110 that completed or were terminated, 23 (21%) have results posted.
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199 of 541 have an industry lead sponsor. The 10 most frequent:
The First Affiliated Hospital of Soochow University is the lead sponsor of 263 studies on the registry; 150 are open to participants now.
The First Affiliated Hospital of Soochow University has 2 studies filed under Prostatic Neoplasms — fewer than ten, so there is no comparison to draw.
97 of the studies in Prostatic Neoplasms with a site in China that are under way reach primary completion within a year, 11 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03258320Phase 3Shanghai Jiao Tong University School of MedicineA Randomised Trial of Cabazitaxel, Docetaxel, Mitoxantrone or Satraplatin (CDMS) Plus Surgery for Prostate Cancer Patients | 2026-12 |
| NCT04691804Phase 3Jiangsu HengRui Medicine Co., Ltd.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study of Fuzuloparib Combined With Abiraterone Acetate and Prednisone (AA-P) Versus Placebo Combined With AA-P as First-Line Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer | 2026-12-31 |
| NCT06551324Phase 3PfizerA Study to Learn About the Investigational Medicine Called PF-06821497 (Mevrometostat) in Men With mCRPC Who Were Previously Treated With Abiraterone Acetate for Prostate Cancer (MEVPRO-1). | 2027-02-28 |
| NCT07241416Phase 3Jiangsu HengRui Medicine Co., Ltd.A Phase III Clinical Study of Rezvilutamide in Patients With Metastatic Hormone-Sensitive Prostate Cancer | 2027-03 |
| NCT02531516Phase 3Aragon Pharmaceuticals, Inc.An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS | 2027-03-01 |
Add all 97 to your calendar (.ics) → With an account.
Among the 541 studies in Prostatic Neoplasms with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study will evaluate the diagnostic performance and safety of gallium-68 (68Ga)-labeled dual-target imaging agents in patients with prostate cancer. These investigational agents are designed to target either EphA2 and prostate-specific membrane antigen (PSMA), or ACP3 and PSMA, for positron emission tomography/computed tomography (PET/CT) imaging.
The main aims are to assess how well these imaging agents detect prostate cancer lesions, evaluate their safety, and estimate the radiation doses received by different organs and the body as a whole. The study will also explore their potential use in early diagnosis, determining the extent of cancer spread, and detecting cancer recurrence.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Male, aged 18-80 years.
confirmed prostate cancer, including newly diagnosed disease, recurrence after surgery, or disease.
At least one measurable or evaluable lesion.
(ECOG) performance status of 0-2.
Hematological parameters, liver and kidney function, and electrolyte levels meeting protocol-defined requirements.
Ability to cooperate with and complete PET/CT imaging.
Exclusion Criteria:
Severe, uncontrolled disease affecting vital organs, including the heart, liver, or kidneys.
Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in the study.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with prostate cancer will receive an intravenous injection of a 68Ga-labeled EphA2/PSMA dual-target radiotracer and undergo PET/CT imaging. Diagnostic performance, safety, biodistribution, and radiation dosimetry will be evaluated. Imaging findings will be compared with \[18F\]FDG PET/CT or single-target PSMA PET/CT findings according to the study protocol.
Diagnostic Test: 68Ga-Labeled EphA2/PSMA Dual-Target Radiotracer PET/CT imaging
Patients with prostate cancer will receive an intravenous injection of a 68Ga-labeled ACP3/PSMA dual-target radiotracer and undergo PET/CT imaging. Diagnostic performance, safety, biodistribution, and radiation dosimetry will be evaluated. Imaging findings will be compared with \[18F\]FDG PET/CT or single-target PSMA PET/CT findings according to the study protocol.
Diagnostic Test: 68Ga-Labeled ACP3/PSMA Dual-Target Radiotracer PET/CT imaging
An investigational gallium-68-labeled radiotracer targeting both EphA2 and PSMA. The radiotracer will be administered intravenously to patients with prostate cancer, followed by PET/CT imaging to evaluate diagnostic performance, biodistribution, and radiation dosimetry. Safety will be assessed by monitoring adverse events.
An investigational gallium-68-labeled radiotracer targeting both ACP3 and PSMA. The radiotracer will be administered intravenously to patients with prostate cancer, followed by PET/CT imaging to evaluate diagnostic performance, biodistribution, and radiation dosimetry. Safety will be assessed by monitoring adverse events.
Safety
Participants who experience at least one new or worsening adverse event during the observation period will be counted. Each participant will be counted once, regardless of the number of events.
Time frame: From radiotracer injection to 24 hours post-injection
Diagnostic efficacy
At the patient level, the detection rate will be calculated as the percentage of participants with an evaluable \[68Ga\]Ga-Dual-Target Radiotracer PET/CT scan showing at least one PET-positive tumor lesion. The number of PET-positive tumor lesions per participant will also be recorded. At the lesion level, tracer uptake will be quantified using the maximum standardized uptake value (SUVmax), and lesion contrast will be assessed using the tumor-to-background ratio (TBR).
Time frame: Through study completion, an average of 6 months
Dosimetry
The absorbed dose from \[68Ga\]Ga-Dual-Target Radiotracer will be estimated separately for each target organ and expressed in milligrays per megabecquerel of administered activity (mGy/MBq).
Time frame: Through study completion, an average of 6 months
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Mar 2028, 18 months after the start.
Of 244 non-industry phase 1 interventional studies under Prostatic Neoplasms, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 76. This study's planned 18 months is below that.
Counting every sponsor, half of 456 studies reached it within 43 months; a quarter within 23 and three quarters within 68.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital of Soochow University →