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The value of PSMA PET/CT in guiding the exemption of pelvic lymph node dissection in intermediate-risk prostate cancer patients: an observational study

The value of PSMA PET/CT in guiding the exemption of pelvic lymph node dissection in intermediate-risk prostate cancer patients: an observational study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500114944
Enrollment
Unknown
Registered
2025-12-19
Start date
2025-12-23
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Intermediate-risk prostate cancer patients

Interventions

Intermediate-risk prostate cancer patients group:None

Sponsors

The Third Affiliated Hospital Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Diagnosis and Risk Stratification: Prostate adenocarcinoma confirmed by pathological biopsy and strictly defined as intermediate-risk according to the latest American National Comprehensive Cancer Network (NCCN) guidelines, meeting any one of the following conditions: (1) Clinical stage T2b-T2c, Gleason score <= 7, and PSA < 20 ng/mL; (2) Clinical stage T1-T2a, Gleason score = 7, and PSA < 20 ng/mL; (3) Clinical stage T1-T2a, Gleason score <= 6, and PSA 10-20 ng/mL; 2. Imaging Assessment: A PSMA PET/CT scan meeting quality control standards was completed at the imaging center designated for this study, prior to radical prostatectomy or the decision to undergo active surveillance; 3. Treatment and Follow-up Pathways: Subsequent clinical management meets at least one of the following pathways: (1) Underwent radical prostatectomy; (2) Initially opted for active surveillance or an active follow-up program, with regular follow-up records. 4. Ethics and Informed Consent: This study has been reviewed by the hospital's ethics committee and obtained written informed consent from the patients.

Exclusion criteria

Exclusion criteria: 1. Does not meet risk stratification: After review, the patient has low-risk, high-risk, or very high-risk prostate cancer; 2. Received prior treatment: The patient has received any form of prostate cancer-related treatment before the PSMA PET/CT scan or radical prostatectomy; 3. Severe missing data: Key clinical data are missing; 4. Lost to follow-up: Patients included in the active surveillance group but with no subsequent follow-up records; 5. Concurrent other malignancies: Currently has another active malignancy.

Design outcomes

Primary

MeasureTime frame
Biochemical recurrence (BCR) rate and treatment conversion rate;

Secondary

MeasureTime frame
Incidence of complications;Factors Affecting the Diagnostic Performance of PSMA PET;

Countries

China

Contacts

Public ContactLiangjun Xie

The Third Affiliated Hospital Sun Yat-sen University

xielj9@mail.sysu.edu.cn+86 20 85253137

Outcome results

None listed

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