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A prospective, multicenter, randomized controlled clinical study of PSMA combined with 18F-FDG PET/CT for the diagnosis of biochemical recurrence of castration-resistant prostate cancer

Radiography and Nuclear Medicine

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000035576
Enrollment
Unknown
Registered
2020-08-14
Start date
2020-09-01
Completion date
Unknown
Last updated
2020-08-17

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

Conditions

prostate cancer

Interventions

Gold Standard:1) Prostate cancer is confirmed by biopsy or puncture pathology
2) The follow-up images of the baseline bone lesions become osteogenic lesions
3) The baseline is soft tissue lesions that meet at least 3 of the following points are also judged as positive. a typical multiple metastases
b lesions enlar
PET/CT

Sponsors

Fudan University Shanghai Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Volunteer to participate and sign informed consent 2. Age = 18 years old 3. Prostate acinar adenocarcinoma and its variants confirmed by puncture or surgical pathology, except for urothelial carcinoma, basal cell carcinoma, small cell carcinoma, etc. 4. Previously received radical treatment of prostate, including radical surgery or radical radiotherapy 5. Meet one or more of the following high-risk prostate cancer criteria: a PSA has been greater than 20 ng/ml; b ISUP is grouped in grade 3-5; c clinical stage T3 or higher 6. Baseline testosterone T<50 ng/dl, serum PSA 0.2-10ng/ml 7. ECOG score 0-1 points 8. The expected survival time is greater than 6 months

Exclusion criteria

Exclusion criteria: 1. Imaging examinations have been performed 4 weeks before randomization. 2. Those who are allergic to iodine contrast agents, have allergies, or are allergic to multiple drugs 3. Before the injection of 18F-FDG, the fasting blood glucose level exceeded 10.0 mmol/L (rapid blood glucose meter test) 4. People with claustrophobia 5. Researchers believe that it is inappropriate to participate in this clinical trial 6. Those who have participated in clinical trials or are participating in other clinical trials in the past month 7. Patients with other malignant tumors

Design outcomes

Primary

MeasureTime frame
Diagnostic power;

Secondary

MeasureTime frame
PFS;PSA progress time;

Countries

China

Contacts

Public Contactshaoli song
shaoli-song@163.com13816608573

Outcome results

None listed

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