Glow-in-the-Dark dye could help surgeons spot hidden prostate cancer
NCT ID NCT07387510
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a special dye called DGPR1008 that makes prostate cancer cells glow under near-infrared light during surgery. About 27 men with prostate cancer will receive the dye before their prostate removal surgery. The goal is to see if the dye helps surgeons find and remove all cancer tissue more accurately.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 27 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 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; 2. 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; 3. Adult male subjects aged 18 years or older (including the boundary value); 4. 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; 5. 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); 6. The investigator determines the subject has no clear contraindications for surgery and is suitable for radical prostatectomy; 7. 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. Exclusion Criteria: Subjects will be excluded if they meet any one of the following criteria: 1. 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); 2. 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); 3. Subjects who participated in another clinical trial involving investigational drugs or devices within the month preceding study drug administration; 4. Subjects who have undergone neoadjuvant therapy, radiation therapy, focal ablation therapy, hormone therapy, or androgen deprivation therapy within the past 6 months; 5. Subjects deemed by the investigator to have other conditions rendering them unsuitable for participation in this trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.