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NCT07101354: DGPR1008
Research on PSMA-Targeted Intraoperative Fluorescent Imaging Agents
Phase 1 trial testing 0.01mg/kg DGPR1008 Injection Dose Group 1 (n=6) in Prostate Cancer Patients Undergoing Radical Prostatectomy in 32 participants. Completed in 24 September 2024.
29 July 2024
Quick facts
| Lead sponsor | Haitao Niu, MD |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | factorial |
| Masking | quadruple |
| Primary purpose | other |
| Enrollment | 32 |
| Start date | 24 June 2024 |
| Primary completion | 29 July 2024 |
| Estimated completion | 24 September 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- 0.01mg/kg DGPR1008 Injection Dose Group 1 (n=6) — full drug profile →
- 0.02mg/kg DGPR1008 Injection Dose Group 2 (n=6) — full drug profile →
- 0.04mg/kg DGPR1008 Injection Dose Group 3 (n=6) — full drug profile →
- 0.08mg/kg DGPR1008 Injection Dose Group 4 (n=6) — full drug profile →
- Dose Group 0 (n=8) — full drug profile →
Conditions studied
- Prostate Cancer Patients Undergoing Radical Prostatectomy — all drugs for Prostate Cancer Patients Undergoing Radical Prostatectomy →
- Prostate CA — all drugs for Prostate CA →
Sponsor
Haitao Niu, MD — full company profile →
Who can join
Adults 18 to 65, male only, with Prostate Cancer Patients Undergoing Radical Prostatectomy or Prostate CA. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Phase I: Primary Research Objective: Evaluate the safety, tolerability, and pharmacokinetic characteristics of a single dose of DGPR1008 in healthy subjects. Secondary Research Objective: Based on the safety and pharmacokinetic results, assess the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) of DGPR1008.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT07101354
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Prostate Cancer Patients Undergoing Radical Prostatectomy
Currently open trials in the same condition.
- NCT07308990 — Limited Versus Extended Lymph Node Dissection During Radical Prostatectomy in Patients With Localized or Locally Advance · NA · recruiting
- NCT06636682 — FK-PC101 as Adjuvant Therapy for Men With High-Risk Prostate Cancer · Phase 2 · recruiting
Other Haitao Niu, MD trials
Trials by the same sponsor.
- NCT07387510 — PSMA-Targeted Intraoperative Fluorescent Imaging Agents (DGPR1008): Validation Across Different Time Windows · Phase 2 · not yet recruiting
- NCT07024030 — Safety and Efficacy Trial of a Targeted PSMA Fluorescent Contrast Agent (DGPR1008) for Intraoperative Imaging of Prostat · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07101354 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Haitao Niu, MD
- Last refreshed: 3 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07101354.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing