Prostate Cancer Patients Undergoing Radical ProstatectomyPhase 2DGPR1008-04NCT07387510
PSMA-Targeted Intraoperative Fluorescent Imaging Agents (DGPR1008): Validation Across Different Time Windows
A Phase 2 study testing 12 h before RP, 24 h before RP and 36 h before RP in people with Prostate Cancer Patients Undergoing Radical Prostatectomy, run by Haitao Niu, MD at 1 site in China.
Trial summary
a Phase II, single-arm, open-label, multi-center study to evaluate safety, tolerability, pharmacokinetics, and the effectiveness of near-infrared fluorescence imaging during surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Patients Undergoing Radical Prostatectomy
- What is being tested?
- 12 h before RP, 24 h before RP and 36 h before RP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteChina
- Study dates
- 27 Feb 2026to 27 Sep 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 diagnosed with prostate cancer through preoperative transrectal prostate biopsy and pathological examination, who are scheduled to undergo radical prostatectomy with or without pelvic lymph node dissection;
- Subjects must provide informed consent prior to trial initiation, fully understand the trial content, procedures, and potential adverse reactions, be capable of effective communication with the investigator, and be able to complete the trial as per protocol requirements. They must voluntarily sign a written informed consent form;
- Adult male subjects aged 18 years or older (including the boundary value);
- Gleason score ≥7, or imaging studies (transrectal ultrasound [TRUS] and/or prostate magnetic resonance imaging [MRI] or CT or PSMA PET/CT) demonstrating disease staging ≥T2, or imaging evidence of regional lymph node enlargement suggestive of lymph node metastasis;
- No hepatic or renal impairment: Hepatic: Total bilirubin ≤ 2 times the upper limit of normal (ULN) (excluding Gilbert syndrome), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3×ULN; Renal: Creatinine clearance ≥ 50 mL/min/1.73 m² (simplified MDRD formula);
- The investigator determines the subject has no clear contraindications for surgery and is suitable for radical prostatectomy;
- The subject and their partner or spouse must agree to have no plans for pregnancy or sperm donation from the screening period until 3 months after trial completion, and voluntarily use effective contraception.
Who cannot join
- Subjects will be excluded if they meet any one of the following criteria:
- Subjects with a history of allergies (e.g., known allergies to two or more medications), those prone to allergic reactions such as rashes or hives, or those with known allergies to the investigational drug (including its formulation components);
- Subjects with significantly abnormal screening test results deemed clinically significant by the investigator and likely to affect study participation; or those with concomitant conditions posing serious safety risks or impeding study completion (except where the investigator determines the condition is stable and allows enrollment);
- Subjects who participated in another clinical trial involving investigational drugs or devices within the month preceding study drug administration;
- Subjects who have undergone neoadjuvant therapy, radiation therapy, focal ablation therapy, hormone therapy, or androgen deprivation therapy within the past 6 months;
- Subjects deemed by the investigator to have other conditions rendering them unsuitable for participation in this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
Shengxian Li, +86 18661808767, lishengxian@qdu.edu.cn
About this study
Official title: A Phase Ⅱ, Single-arm, Open-label Trial of DGPR1008 for Intraoperative Fluorescence Imaging of Prostate-specific Membrane Antigen-positive Prostate Cancer
a Phase II, single-arm, open-label, multi-center study to evaluate safety, tolerability, pharmacokinetics, and the effectiveness of near-infrared fluorescence imaging during surgery.
Read the detailed description
We plan to enroll 27 prostate cancer patients and divide them into 3 different time-window groups. Intravenous administration will be conducted 12/24/36 hours before surgery. Blood samples will be collected for relevant tests, and fluorescence imaging will be performed during the operation. After surgery, the intraoperative imaging results will be compared with pathological findings to draw relevant conclusions.
- Being tested
- 12 h before RP, 24 h before RP, 36 h before RP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12 h before RPDrug
DGPR1008 (0.04 mg/kg according to each subject's body weight) was given as a single slow infusion 12 hours (±4 hours) preoperatively, after which radical prostatectomy was performed. The investigator shall conduct near-infrared fluorescence imaging during the operation to assist with the surgery. Tissues detected with fluorescence need to be marked, and resection shall be guided by fluorescence until there is no fluorescent tissue within the surgical field.
24 h before RPDrug
DGPR1008 (0.04 mg/kg according to each subject's body weight) was given as a single slow infusion 24 hours (±4 hours) preoperatively, after which radical prostatectomy was performed. The investigator shall conduct near-infrared fluorescence imaging during the operation to assist with the surgery. Tissues detected with fluorescence need to be marked, and resection shall be guided by fluorescence until there is no fluorescent tissue within the surgical field.
36 h before RPDrug
DGPR1008 (0.04 mg/kg according to each subject's body weight) was given as a single slow infusion 36 hours (±4 hours) preoperatively, after which radical prostatectomy was performed. The investigator shall conduct near-infrared fluorescence imaging during the operation to assist with the surgery. Tissues detected with fluorescence need to be marked, and resection shall be guided by fluorescence until there is no fluorescent tissue within the surgical field.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | DGPR1008 (0.04 mg/kg according to each subject's body weight) was given as a single slow infusion 12 hours (±4 hours) preoperatively, after which radical prostatectomy was performed. The investigator shall conduct near-infrared fluorescence imaging during the operation to assist with the surgery. Tissues detected with fluorescence need to be marked, and resection shall be guided by fluorescence until there is no fluorescent tissue within the surgical field. Receives: Drug: 12 h before RP |
| group 2 | Experimental | DGPR1008 (0.04 mg/kg according to each subject's body weight) was given as a single slow infusion 24 hours (±4 hours) preoperatively, after which radical prostatectomy was performed. The investigator shall conduct near-infrared fluorescence imaging during the operation to assist with the surgery. Tissues detected with fluorescence need to be marked, and resection shall be guided by fluorescence until there is no fluorescent tissue within the surgical field. Receives: Drug: 24 h before RP |
| group 3 | Experimental | DGPR1008 (0.04 mg/kg according to each subject's body weight) was given as a single slow infusion 36 hours (±4 hours) preoperatively, after which radical prostatectomy was performed. The investigator shall conduct near-infrared fluorescence imaging during the operation to assist with the surgery. Tissues detected with fluorescence need to be marked, and resection shall be guided by fluorescence until there is no fluorescent tissue within the surgical field. Receives: Drug: 36 h before RP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the efficacy of DGPR-1008 (administered 12 hours prior) in conjunction with a near-infrared fluorescence imaging device for intraoperative detection in patients.
Detection of prostate cancer tissue by DGPR1008 using near-infrared fluorescence (NIR) imaging at 12 hours after intravenous administration to subjects. Evaluate the sensitivity (or true positive rate, TP/[TP+FN]), specificity (or true negative rate, TN/[TN+FP]), false positive rate (FP/[FP+TN]), and false negative rate (FN/[FN+TP]) of DGPR-1008 for detecting prostate cancer tissue in near-infrared fluorescence imaging (NIR) during radical prostatectomy. The proportion of additionally resected tissues that are diagnosed as tumors by pathological evaluation.
Measured: From the screening period to the Day 7 of the trial
Evaluate the efficacy of DGPR-1008 (administered 24 hours prior) in conjunction with a near-infrared fluorescence imaging device for intraoperative detection in patients.
Detection of prostate cancer tissue by DGPR1008 using near-infrared fluorescence (NIR) imaging at 24 hours after intravenous administration to subjects. Evaluate the sensitivity (or true positive rate, TP/[TP+FN]), specificity (or true negative rate, TN/[TN+FP]), false positive rate (FP/[FP+TN]), and false negative rate (FN/[FN+TP]) of DGPR-1008 for detecting prostate cancer tissue in near-infrared fluorescence imaging (NIR) during radical prostatectomy. The proportion of additionally resected tissues that are diagnosed as tumors by pathological evaluation.
Measured: From the screening period to the Day 7 of the trial
Evaluate the efficacy of DGPR-1008 (administered 36 hours prior) in conjunction with a near-infrared fluorescence imaging device for intraoperative detection in patients.
Detection of prostate cancer tissue by DGPR1008 using near-infrared fluorescence (NIR) imaging at 36 hours after intravenous administration to subjects. Evaluate the sensitivity (or true positive rate, TP/[TP+FN]), specificity (or true negative rate, TN/[TN+FP]), false positive rate (FP/[FP+TN]), and false negative rate (FN/[FN+TP]) of DGPR-1008 for detecting prostate cancer tissue in near-infrared fluorescence imaging (NIR) during radical prostatectomy. The proportion of additionally resected tissues that are diagnosed as tumors by pathological evaluation.
Measured: From the screening period to the Day 7 of the trial
Secondary outcomes (3)
Evaluate DGPR1008 combined with near-infrared fluorescence imaging devices for detecting positive margins in histopathological examination following radical prostatectomy
To evaluate the proportion of subjects with a positive surgical margin (PSM) score of ≥1, as assessed by histopathology, at different time points after radical prostatectomy.
Measured: From the screening period to the Day 7 of the trial
Evaluate DGPR1008 combined with near-infrared fluorescence imaging devices for detecting positive lymph nodes in histopathological examination following radical prostatectomy
To evaluate the proportion of subjects with positive lymph nodes, as assessed by histopathology, at different time points after radical prostatectomy.
Measured: From the screening period to the Day 7 of the trial
Evaluate the safety of single-dose administration of DGPR1008 in patients
Adverse event collection, including (such as the location, nature, and frequency of pain), physical signs (such as the scope of rash, blood pressure values), laboratory abnormal values and units (such as ALT 200 U/L), etc.
Measured: From the screening period to the Day 7 of the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start27 Feb 2026 (estimated)
- Primary completion27 Jul 2026 (estimated)
- Study completion27 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer Patients Undergoing Radical ProstatectomyStudies 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
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haitao Niu, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Haitao Niu, MD, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07387510
- Sponsor's protocol ID
- QYFYEC2026-009-01
- Acronym
- DGPR1008-04
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2026
- Last updated
- 4 Feb 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 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅱ, Single-arm, Open-label Trial of DGPR1008 for Intraoperative Fluorescence Imaging of Prostate-specific Membrane Antigen-positive Prostate Cancer
- ClinicalTrials.gov ID
- NCT07387510
- Acronym / sponsor ID
- DGPR1008-04 / QYFYEC2026-009-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Haitao Niu, MDUniversity, hospital or other
- Study start
- 27 Feb 2026 (estimated)
- Primary completion
- 27 Jul 2026 (estimated)
- Study completion
- 27 Sep 2026 (estimated)
- First posted
- 4 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.
a Phase II, single-arm, open-label, multi-center study to evaluate safety, tolerability, pharmacokinetics, and the effectiveness of near-infrared fluorescence imaging during surgery.
Detailed description
We plan to enroll 27 prostate cancer patients and divide them into 3 different time-window groups. Intravenous administration will be conducted 12/24/36 hours before surgery. Blood samples will be collected for relevant tests, and fluorescence imaging will be performed during the operation. After surgery, the intraoperative imaging results will be compared with pathological findings to draw relevant conclusions.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Drug: 12 h before RPDGPR1008 (0.04 mg/kg according to each subject's body weight) was given as a single slow infusion 12 hours (±4 hours) preoperatively, after which radical prostatectomy was performed. The investigator shall conduct near-infrared fluorescence imaging during the operation to assist with the surgery. Tissues detected with fluorescence need to be marked, and resection shall be guided by fluorescence until there is no fluorescent tissue within the surgical field. |
| group 2 | Experimental | Drug: 24 h before RPDGPR1008 (0.04 mg/kg according to each subject's body weight) was given as a single slow infusion 24 hours (±4 hours) preoperatively, after which radical prostatectomy was performed. The investigator shall conduct near-infrared fluorescence imaging during the operation to assist with the surgery. Tissues detected with fluorescence need to be marked, and resection shall be guided by fluorescence until there is no fluorescent tissue within the surgical field. |
| group 3 | Experimental | Drug: 36 h before RPDGPR1008 (0.04 mg/kg according to each subject's body weight) was given as a single slow infusion 36 hours (±4 hours) preoperatively, after which radical prostatectomy was performed. The investigator shall conduct near-infrared fluorescence imaging during the operation to assist with the surgery. Tissues detected with fluorescence need to be marked, and resection shall be guided by fluorescence until there is no fluorescent tissue within the surgical field. |
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 diagnosed with prostate cancer through preoperative transrectal prostate biopsy and pathological examination, who are scheduled to undergo radical prostatectomy with or without pelvic lymph node dissection;
- Subjects must provide informed consent prior to trial initiation, fully understand the trial content, procedures, and potential adverse reactions, be capable of effective communication with the investigator, and be able to complete the trial as per protocol requirements. They must voluntarily sign a written informed consent form;
- Adult male subjects aged 18 years or older (including the boundary value);
- Gleason score ≥7, or imaging studies (transrectal ultrasound [TRUS] and/or prostate magnetic resonance imaging [MRI] or CT or PSMA PET/CT) demonstrating disease staging ≥T2, or imaging evidence of regional lymph node enlargement suggestive of lymph node metastasis;
- No hepatic or renal impairment: Hepatic: Total bilirubin ≤ 2 times the upper limit of normal (ULN) (excluding Gilbert syndrome), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3×ULN; Renal: Creatinine clearance ≥ 50 mL/min/1.73 m² (simplified MDRD formula);
Key exclusion criteria (6 listed)
- Subjects with a history of allergies (e.g., known allergies to two or more medications), those prone to allergic reactions such as rashes or hives, or those with known allergies to the investigational drug (including its formulation components);
- Subjects with significantly abnormal screening test results deemed clinically significant by the investigator and likely to affect study participation; or those with concomitant conditions posing serious safety risks or impeding study completion (except where the investigator determines the condition is stable and allows enrollment);
- Subjects who participated in another clinical trial involving investigational drugs or devices within the month preceding study drug administration;
- Subjects who have undergone neoadjuvant therapy, radiation therapy, focal ablation therapy, hormone therapy, or androgen deprivation therapy within the past 6 months;
- Subjects deemed by the investigator to have other conditions rendering them unsuitable for participation in this trial.
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 |
|---|---|---|
| 12 h before RPDGPR1008 (0.04 mg/kg according to each subject's body weight) was given as a single slow infusion 12 hours (±4 hours) preoperatively, after which radical prostatectomy was performed. The investigator shall conduct near-infrared fluorescence imaging during the operation to assist with the surgery. Tissues detected with fluorescence need to be marked, and resection shall be guided by fluorescence until there is no fluorescent tissue within the surgical field. | Drug | group 1 |
| 24 h before RPDGPR1008 (0.04 mg/kg according to each subject's body weight) was given as a single slow infusion 24 hours (±4 hours) preoperatively, after which radical prostatectomy was performed. The investigator shall conduct near-infrared fluorescence imaging during the operation to assist with the surgery. Tissues detected with fluorescence need to be marked, and resection shall be guided by fluorescence until there is no fluorescent tissue within the surgical field. | Drug | group 2 |
| 36 h before RPDGPR1008 (0.04 mg/kg according to each subject's body weight) was given as a single slow infusion 36 hours (±4 hours) preoperatively, after which radical prostatectomy was performed. The investigator shall conduct near-infrared fluorescence imaging during the operation to assist with the surgery. Tissues detected with fluorescence need to be marked, and resection shall be guided by fluorescence until there is no fluorescent tissue within the surgical field. | Drug | group 3 |
Primary outcome
Evaluate the efficacy of DGPR-1008 (administered 12 hours prior) in conjunction with a near-infrared fluorescence imaging device for intraoperative detection in patients.
Time frame: From the screening period to the Day 7 of the trial
Detection of prostate cancer tissue by DGPR1008 using near-infrared fluorescence (NIR) imaging at 12 hours after intravenous administration to subjects. Evaluate the sensitivity (or true positive rate, TP/[TP+FN]), specificity (or true negative rate, TN/[TN+FP]), false positive rate (FP/[FP+TN]), and false negative rate (FN/[FN+TP]) of DGPR-1008 for detecting prostate cancer tissue in near-infrared fluorescence imaging (NIR) during radical prostatectomy. The proportion of additionally resected tissues that are diagnosed as tumors by pathological evaluation.
Evaluate the efficacy of DGPR-1008 (administered 24 hours prior) in conjunction with a near-infrared fluorescence imaging device for intraoperative detection in patients.
Time frame: From the screening period to the Day 7 of the trial
Detection of prostate cancer tissue by DGPR1008 using near-infrared fluorescence (NIR) imaging at 24 hours after intravenous administration to subjects. Evaluate the sensitivity (or true positive rate, TP/[TP+FN]), specificity (or true negative rate, TN/[TN+FP]), false positive rate (FP/[FP+TN]), and false negative rate (FN/[FN+TP]) of DGPR-1008 for detecting prostate cancer tissue in near-infrared fluorescence imaging (NIR) during radical prostatectomy. The proportion of additionally resected tissues that are diagnosed as tumors by pathological evaluation.
Evaluate the efficacy of DGPR-1008 (administered 36 hours prior) in conjunction with a near-infrared fluorescence imaging device for intraoperative detection in patients.
Time frame: From the screening period to the Day 7 of the trial
Detection of prostate cancer tissue by DGPR1008 using near-infrared fluorescence (NIR) imaging at 36 hours after intravenous administration to subjects. Evaluate the sensitivity (or true positive rate, TP/[TP+FN]), specificity (or true negative rate, TN/[TN+FP]), false positive rate (FP/[FP+TN]), and false negative rate (FN/[FN+TP]) of DGPR-1008 for detecting prostate cancer tissue in near-infrared fluorescence imaging (NIR) during radical prostatectomy. The proportion of additionally resected tissues that are diagnosed as tumors by pathological evaluation.
3 secondary outcomes
Evaluate DGPR1008 combined with near-infrared fluorescence imaging devices for detecting positive margins in histopathological examination following radical prostatectomy
Time frame: From the screening period to the Day 7 of the trial
Evaluate DGPR1008 combined with near-infrared fluorescence imaging devices for detecting positive lymph nodes in histopathological examination following radical prostatectomy
Time frame: From the screening period to the Day 7 of the trial
Evaluate the safety of single-dose administration of DGPR1008 in patients
Time frame: From the screening period to the Day 7 of the trial
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: Yes
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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.
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 12 h before RP, 24 h before RP and 36 h before RP in people with Prostate Cancer Patients Undergoing Radical Prostatectomy, run by Haitao Niu, MD 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 6 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: opening soon, as of the sponsor's last update on 4 Feb 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haitao Niu (86+0532-82911329, niuht0532@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the efficacy of DGPR-1008 (administered 12 hours prior) in conjunction with a near-infrared fluorescence imaging device for intraoperative detection in patients. (time frame: From the screening period to the Day 7 of the trial). The study lists 3 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 4 Feb 2026.