Evaluation of the Metastasis and Recurrence of Prostate Cancer

NCT ID: NCT03507595

Last Updated: 2018-04-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2019-12-31

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.

Conditions

Prostate Cancer (Diagnosis); Prostate Cancer Metastatic; Prostate Cancer Recurrent; Prostate Cancer Stage

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with initial diagnosis of PCa

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.

No interventions assigned to this group

Patients with biochemical recurrent PCa

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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.

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hongliang Fu, MD

Role: PRINCIPAL_INVESTIGATOR

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Locations

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hui Wang, MD

Role: CONTACT

wanghuishanghai@hotmail.com

+86-021-25076980

Jun Qi, MD

Role: CONTACT

qijun@xinhuamed.com.cn

+86-021-25078080

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

XH-17-020

Identifier Type: -

Identifier Source: org_study_id