Evaluation of the Metastasis and Recurrence of Prostate Cancer

• Conditions: Prostate Cancer Metastatic; Prostate Cancer Stage; Prostate Cancer (Diagnosis); Prostate Cancer Recurrent

• Registration Number: NCT03507595
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary

This study aims to use the new molecular probe 18F-PSMA for the diagnosis,staging ,recurrence monitoring and evaluation of the prostate cancer.By compared with the conventional imaging methods (whole body bone scintigraphy and MRI) and molecular imaging methods (11C-choline PET/CT),we hope to find the advantages of 18F-PSMA PET/CT in the diagnosis and metastases of prostate cancer, and lay the foundation for the further clinical transformation.

Detailed Description

This study aims to use the new molecular probe 18F-PSMA for the diagnosis,staging ,recurrence monitoring and evaluation of the prostate cancer.By compared with the conventional imaging methods (whole body bone scintigraphy and MRI) and molecular imaging methods (11C-choline PET/CT),we hope to find the advantages of 18F-PSMA PET/CT in the diagnosis and metastases of prostate cancer, and lay the foundation for the further clinical transformation.And make some comparison with those 3 methods.

Study Timeline

• Study Start: 2017-09-01
• Status Verified: 2017-12
• Study First Submitted: 2018-04-16
• Study First Submitted QC: 2018-04-16
• Last Update Submitted: 2018-04-16
• Study First Posted: 2018-04-25
• Last Update Posted: 2018-04-25
• Primary Completion: 2019-10-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 400

Inclusion Criteria

1. Patients with initial diagnosis of prostate cancer; 1）T2 stage: PSA>20ng/ml, Gleason Score >= 8; 2）T3 or T4 stage; 3）The imaging examination was negative or localized metastasis of the pelvic lymph node, but there was no distant metastasis of lymph nodes or bone and internal organs other than the pelvic cavity.
2. Patients with biochemical recurrent prostate cancer; 1）After the RRP surgery, the serum PSA was over 0.2 ng/ml in two consecutive sera; 2）After the radiotherapy: the lowest PSA is up to 2 ng/ml.
3. Patients with CRPC. 1）The serum testosterone is in the castration level (< 50 ng/dL or < 1.7 nmol/L); 2）The PSA is elevated 3 times in a row, the base value is increased by more than 50%, and the PSA > 2ng/mL(the interval is one week); 3）The continuation of the anti-androgen drugs, flunamine was stopped for at least 4 weeks, and biglumide was suspended for at least 6 weeks; 4）Despite the continued standard androgen deprivation therapy, the PSA is still progressing.

Exclusion Criteria

1. Patients who are unwilling to participate in the study or unwilling to sign the informed consent forms;
2. Patients who are critically ill, suffering from mental illness and cannot cooperate with the examination;
3. There are electronic implants, such as pacemakers and insulin pumps in the body, and magnetic metal foreign objects in the spot.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
18F-PSMA PET/CT imaging	4 hours	The outcome of 18F-PSMA PET/CT imaging.

Secondary Outcome Measures

Name	Time	Method
MRI imaging	4 hours	The outcome of MRI imaging.
Bone scan imaging	6 hours	The outcome of bone scan imaging.

Trial Locations

Locations (1)

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China