Prostate CancerPhase 2NCT07415135
Safety and Efficacy of PSMA-Targeted Fluorescent Contrast Agent DGPR1008 for Intraoperative Imaging in Robot-Assisted Radical Prostatectomy
A Phase 2 study testing 0.02 mg/kg of DGPR1008 Injection was administered 24 hours before surgery, 0.04 mg/kg of DGPR1008 Injection was administered 24 hours before surgery and 0.06 mg/kg of DGPR1008 Injection was administered 24 hours before surgery in people with Prostate Cancer, run by Zhu Yinjie at 1 site in China.
Trial summary
This study is a single-center, single-arm, open-label exploratory study to evaluate the safety and efficacy of fluorescent imaging combined with a robotic surgical control system for robot-assisted radical prostatectomy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- 0.02 mg/kg of DGPR1008 Injection was administered 24 hours before surgery, 0.04 mg/kg of DGPR1008 Injection was administered 24 hours before surgery and 0.06 mg/kg of DGPR1008 Injection was administered 24 hours before surgery
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2026to 29 Aug 2026
- Phase
- Phase 2
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with pathologically confirmed prostate cancer via preoperative prostate core needle biopsy who are scheduled to undergo robot-assisted radical prostatectomy (RARP).
- Subjects must provide informed consent for the trial prior to enrollment, with a full understanding of the trial content, procedures and potential adverse events; they must be able to communicate effectively with investigators, comply with the trial protocol to complete the entire study, and voluntarily sign a written informed consent form.
- Male adult subjects aged 18 years or older (inclusive).
- Gleason total score ≥7, or radiological findings (transrectal ultrasound (TRUS) and/or prostate magnetic resonance imaging (MRI), computed tomography (CT) or prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT)) indicating clinical stage ≥T2.
- No hepatic or renal impairment: Hepatic function: Total bilirubin ≤2 × upper limit of normal (ULN) (except for Gilbert's syndrome), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤3 × ULN; Renal function: Creatinine clearance rate ≥50 mL/min/1.73 m² (calculated via the simplified MDRD equation).
- Subjects judged by the investigator to have no definite surgical contraindications and to be suitable for robot-assisted radical prostatectomy (RARP).
- Subjects and their partners/spouses must agree to have no childbearing or sperm donation plans from the screening period to 3 months after the trial completion, and voluntarily adopt effective contraceptive measures.
Who cannot join
- Subjects with an allergic diathesis (e.g., a known history of hypersensitivity to two or more drugs), a predisposition to allergic symptoms such as rashes or urticaria, or a known hypersensitivity to the study drug (including its ingredients).
- Subjects with clinically significant abnormal findings in screening tests that are judged by the investigator to affect the study; or those with comorbidities that pose a serious risk to subject safety or interfere with study completion (except for subjects whose conditions are judged by the investigator to be stable for enrollment).
- Subjects who have participated in other clinical trials and received investigational drugs or medical devices within 1 month prior to the administration of the study drug.
- Subjects who have received neoadjuvant therapy, radiotherapy, focal ablation therapy, hormonal therapy, androgen deprivation therapy, or other such treatments in the past 6 months.
- Subjects who are judged by the investigator to be ineligible for the study due to other circumstances.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase Ⅱ Clinical Study on the Safety and Efficacy of PSMA-Targeted Fluorescent Contrast Agent DGPR1008 for Intraoperative Imaging in Robot-Assisted Radical Prostatectomy
This study is a single-center, single-arm, open-label exploratory study to evaluate the safety and efficacy of fluorescent imaging combined with a robotic surgical control system for robot-assisted radical prostatectomy.
- Conditions
- Prostate Cancer
- Being tested
- 0.02 mg/kg of DGPR1008 Injection was administered 24 hours before surgery, 0.04 mg/kg of DGPR1008 Injection was administered 24 hours before surgery, 0.06 mg/kg of DGPR1008 Injection was administered 24 hours before surgery
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.02 mg/kg of DGPR1008 Injection was administered 24 hours before surgeryDrug
0.02 mg/kg
0.04 mg/kg of DGPR1008 Injection was administered 24 hours before surgeryDrug
0.04 mg/kg
0.06 mg/kg of DGPR1008 Injection was administered 24 hours before surgeryDrug
0.06 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| 0.02mg/kg DGPR1008 Injection Dose Group 1 (n=4~10) | Experimental | 0.02mg/kg Receives: Drug: 0.02 mg/kg of DGPR1008 Injection was administered 24 hours before surgery |
| 0.04mg/kg DGPR1008 Injection Dose Group 1 (n=4~10) | Experimental | 0.04mg/kg Receives: Drug: 0.04 mg/kg of DGPR1008 Injection was administered 24 hours before surgery |
| 0.06mg/kg DGPR1008 Injection Dose Group 1 (n=4~10) | Experimental | 0.06mg/kg Receives: Drug: 0.06 mg/kg of DGPR1008 Injection was administered 24 hours before surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the sensitivity (true positive rate, TP/(TP+FN)), specificity (true negative rate, TN/(TN+FP)), false positive rate (FP/(FP+TN)) and false negative rate (FN/(FN+TP)) of DGPR1008 for detecting prostate cancer tissues via near-infrared fluoresc
Measured: 7 days after administration
To evaluate the proportion of additionally resected tissues (due to fluorescent signals in tumor beds identified by near-infrared fluorescent imaging (NIR)) that are assessed as tumor-positive by histopathological examination after radical prostatectomy.
Measured: 7 days after administration
Secondary outcomes (3)
To evaluate the proportion of subjects with a positive surgical margin (PSM) of ≥1 as assessed by histopathological examination after radical prostatectomy.
Measured: 7 days after administration
Number of participants with Adverse events
Number of participants with Adverse events, with abnormal vital signs assessment, abnormal physical examination findings, abnormal electrocardiogram (ECG) readings, and abnormal laboratory tests including complete blood count (CBC), blood biochemistry, urine routine test, and coagulation function tests
Measured: 7 days after administration
To evaluate the Tumor-to-Background Ratio (TBR)
Measured: 7 days after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start20 Mar 2026
- Primary completion29 Aug 2026
- Study completion29 Aug 2026
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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhu Yinjie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhu Yinjie, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07415135
- Sponsor's protocol ID
- Zhu Yinjie
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ⅱ Clinical Study on the Safety and Efficacy of PSMA-Targeted Fluorescent Contrast Agent DGPR1008 for Intraoperative Imaging in Robot-Assisted Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT07415135
- Acronym / sponsor ID
- Zhu Yinjie
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Zhu YinjieUniversity, hospital or other
- Study start
- 20 Mar 2026 (actual)
- Primary completion
- 29 Aug 2026 (actual)
- Study completion
- 29 Aug 2026 (actual)
- First posted
- 17 Feb 2026 (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.
This study is a single-center, single-arm, open-label exploratory study to evaluate the safety and efficacy of fluorescent imaging combined with a robotic surgical control system for robot-assisted radical prostatectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.02mg/kg DGPR1008 Injection Dose Group 1 (n=4~10) | Experimental | Drug: 0.02 mg/kg of DGPR1008 Injection was administered 24 hours before surgery0.02mg/kg |
| 0.04mg/kg DGPR1008 Injection Dose Group 1 (n=4~10) | Experimental | Drug: 0.04 mg/kg of DGPR1008 Injection was administered 24 hours before surgery0.04mg/kg |
| 0.06mg/kg DGPR1008 Injection Dose Group 1 (n=4~10) | Experimental | Drug: 0.06 mg/kg of DGPR1008 Injection was administered 24 hours before surgery0.06mg/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects with pathologically confirmed prostate cancer via preoperative prostate core needle biopsy who are scheduled to undergo robot-assisted radical prostatectomy (RARP).
- Subjects must provide informed consent for the trial prior to enrollment, with a full understanding of the trial content, procedures and potential adverse events; they must be able to communicate effectively with investigators, comply with the trial protocol to complete the entire study, and voluntarily sign a written informed consent form.
- Male adult subjects aged 18 years or older (inclusive).
- Gleason total score ≥7, or radiological findings (transrectal ultrasound (TRUS) and/or prostate magnetic resonance imaging (MRI), computed tomography (CT) or prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT)) indicating clinical stage ≥T2.
- No hepatic or renal impairment: Hepatic function: Total bilirubin ≤2 × upper limit of normal (ULN) (except for Gilbert's syndrome), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤3 × ULN; Renal function: Creatinine clearance rate ≥50 mL/min/1.73 m² (calculated via the simplified MDRD equation).
Key exclusion criteria (5 listed)
- Subjects with an allergic diathesis (e.g., a known history of hypersensitivity to two or more drugs), a predisposition to allergic symptoms such as rashes or urticaria, or a known hypersensitivity to the study drug (including its ingredients).
- Subjects with clinically significant abnormal findings in screening tests that are judged by the investigator to affect the study; or those with comorbidities that pose a serious risk to subject safety or interfere with study completion (except for subjects whose conditions are judged by the investigator to be stable for enrollment).
- Subjects who have participated in other clinical trials and received investigational drugs or medical devices within 1 month prior to the administration of the study drug.
- Subjects who have received neoadjuvant therapy, radiotherapy, focal ablation therapy, hormonal therapy, androgen deprivation therapy, or other such treatments in the past 6 months.
- Subjects who are judged by the investigator to be ineligible for the study due to other circumstances.
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 |
|---|---|---|
| 0.02 mg/kg of DGPR1008 Injection was administered 24 hours before surgery0.02 mg/kg | Drug | 0.02mg/kg DGPR1008 Injection Dose Group 1 (n=4~10) |
| 0.04 mg/kg of DGPR1008 Injection was administered 24 hours before surgery0.04 mg/kg | Drug | 0.04mg/kg DGPR1008 Injection Dose Group 1 (n=4~10) |
| 0.06 mg/kg of DGPR1008 Injection was administered 24 hours before surgery0.06 mg/kg | Drug | 0.06mg/kg DGPR1008 Injection Dose Group 1 (n=4~10) |
Primary outcome
To evaluate the sensitivity (true positive rate, TP/(TP+FN)), specificity (true negative rate, TN/(TN+FP)), false positive rate (FP/(FP+TN)) and false negative rate (FN/(FN+TP)) of DGPR1008 for detecting prostate cancer tissues via near-infrared fluoresc
Time frame: 7 days after administration
To evaluate the proportion of additionally resected tissues (due to fluorescent signals in tumor beds identified by near-infrared fluorescent imaging (NIR)) that are assessed as tumor-positive by histopathological examination after radical prostatectomy.
Time frame: 7 days after administration
3 secondary outcomes
To evaluate the proportion of subjects with a positive surgical margin (PSM) of ≥1 as assessed by histopathological examination after radical prostatectomy.
Time frame: 7 days after administration
Number of participants with Adverse events
Time frame: 7 days after administration
To evaluate the Tumor-to-Background Ratio (TBR)
Time frame: 7 days after administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Yes
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 0.02 mg/kg of DGPR1008 Injection was administered 24 hours before surgery, 0.04 mg/kg of DGPR1008 Injection was administered 24 hours before surgery and 0.06 mg/kg of DGPR1008 Injection was administered 24 hours before surgery in people with Prostate Cancer, run by Zhu Yinjie 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 7 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: finished, as of the sponsor's last update on 30 Sep 2026. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To evaluate the sensitivity (true positive rate, TP/(TP+FN)), specificity (true negative rate, TN/(TN+FP)), false positive rate (FP/(FP+TN)) and false negative rate (FN/(FN+TP)) of DGPR1008 for detecting prostate cancer tissues via near-infrared fluoresc (time frame: 7 days after administration). The study lists 2 primary outcomes in all. 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 30 Sep 2026.