Evaluation of the Metastasis and Recurrence of Prostate Cancer

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Other)

Overall Status

Unknown status

CT.gov ID

NCT03507595

Collaborator

(none)

400

Enrollment

Location

Anticipated Duration (Months)

14.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer (Diagnosis) Prostate Cancer Metastatic Prostate Cancer Recurrent Prostate Cancer Stage

Detailed Description

Study Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Evaluation of the Metastasis and Recurrence of Prostate Cancer With 18F-PSMA PET/CT

Actual Study Start Date :

Sep 1, 2017

Anticipated Primary Completion Date :

Oct 31, 2019

Anticipated Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Patients with initial diagnosis of PCa T2 stage: PSA>20ng/ml, Gleason Score >= 8; T3 or T4 stage; 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.
Patients with biochemical recurrent PCa After the RRP surgery,the serum PSA was over 0.2 ng/ml in two consecutive sera; After the radiotherapy: the lowest PSA is up to 2 ng/ml.
Patients with CRPC The serum testosterone is in the castration level (< 50 ng/dL or < 1.7 nmol/L); 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); The continuation of the anti-androgen drugs, flunamine was stopped for at least 4 weeks, and biglumide was suspended for at least 6 weeks; Despite the continued standard androgen deprivation therapy, the PSA is still progressing.

Outcome Measures

Primary Outcome Measures

18F-PSMA PET/CT imaging [4 hours]
The outcome of 18F-PSMA PET/CT imaging.

Secondary Outcome Measures

Bone scan imaging [6 hours]
The outcome of bone scan imaging.
MRI imaging [4 hours]
The outcome of MRI imaging.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

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.
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.
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:

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