Evaluation of the Metastasis and Recurrence of Prostate Cancer

Prostate Cancer Metastatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03507595
• Other study ID #: XH-17-020
• Status: Recruiting
• First received: April 16, 2018
• Last updated: April 16, 2018
• Start date: September 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: December 2017
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Hui Wang, MD
• Phone: +86-021-25076980
• Email: wanghuishanghai[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Prostate Cancer (Diagnosis)
• Prostate Cancer Metastatic
• Prostate Cancer Recurrent
• Prostate Cancer Stage
• Prostatic Neoplasms
• Recurrence

Locations

Country	Name	City	State
China	Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	18F-PSMA PET/CT imaging	The outcome of 18F-PSMA PET/CT imaging.	4 hours
Secondary	Bone scan imaging	The outcome of bone scan imaging.	6 hours
Secondary	MRI imaging	The outcome of MRI imaging.	4 hours