PSMA-Targeted Intraoperative Fluorescent Imaging Agents (DGPR1008): Validation Across Different Time Windows
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorHaitao Niu, MD
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- 12 h before RP
- 24 h before RP
- 36 h before RP
Treatment groups
27 Participants
are divided into 3 treatment groupsSponsors and collaborators
Haitao Niu, MD
Lead sponsor
The Affiliated Hospital of Qingdao University
Sponsor institution
Source ClinicalTrials.gov