Glow-in-the-Dark dye could help surgeons spot hidden prostate cancer
NCT ID NCT07415135
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests a fluorescent dye called DGPR1008 that targets prostate cancer cells. Before robot-assisted prostate removal surgery, 18 men with prostate cancer will receive an injection of the dye. During surgery, a special camera will make cancer cells glow, helping surgeons see and remove them more precisely. The goal is to improve cancer removal and reduce the chance of leaving cancer behind.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- DGPR1008 (a fluorescent dye that targets prostate cancer cells)
- What this could lead to
- If successful, this dye could help surgeons remove more cancer tissue during prostate surgery, potentially reducing the chance of leftover cancer cells.
- What could go wrong
- This is a small, early-phase study with only 18 participants, so results may not apply to everyone. The dye's effectiveness and safety are still being tested.
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 18 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 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: * 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. Exclusion Criteria: * 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.
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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 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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a gel cushion shield the rectum during prostate radiation?
- A scanner in the operating room could show surgeons exactly where prostate cancer remains