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PSMA Radionuclide-Fluorescent Dual-Modality Probes for Robotic Radical Prostatectomy

Comparison of Targeted PSMA Radionuclide-Fluorescent Dual-Modality Probes for Preoperative PET Imaging and Intraoperative Fluorescence Guidance with Traditional Robotic Radical Prostatectomy: A Single-Center Randomized Controlled Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100404
Enrollment
Unknown
Registered
2025-04-09
Start date
2025-04-10
Completion date
Unknown
Last updated
2025-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Interventions

RARP-group:Conventional RARP (Fluorescence-Free Navigation)
PSMA-group:Preoperative injection of 68Ga-P3 fluorescent probe and intraoperative robotic-assisted radical prostatectomy (RARP) under fluorescence navigation

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Prostate cancer patients who need robot-assisted radical prostatectomy (RARP). 2. Confirmed by traditional imaging examination (bone scintigraphy, CT or MRI) or PET/CT as M0 (no distant metastasis), pelvic lymph node metastasis (N1) is allowed to enroll 3. Age>=18 years old and <=80 years old 4. Sign the informed consent form

Exclusion criteria

Exclusion criteria: 1. Refusal to sign informed consent or inability to cooperate with the study 2. Unable to tolerate PET/CT or RARP 3. Previous treatment for prostate cancer: Systemic therapy (e.g., ADT >for 2 months, endocrine therapy, chemotherapy, immunotherapy, etc.) for 2 months Local therapies (eg, pelvic radiation therapy, surgery) 4. Other malignant tumors within the past 5 years or at the same time

Design outcomes

Primary

MeasureTime frame
Surgical Margin;

Secondary

MeasureTime frame
Postoperation of PSA;

Countries

China

Contacts

Public ContactLi Xuesong, Shen Cheng

Peking University First Hospital

shencheng@263.com+86 139 1109 6035

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026