Evaluation of the Metastasis and Recurrence of Prostate Cancer

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Hui Wang, MD; Phone Number: +86-021-25076980; Email: wanghuishanghai@hotmail.com
• Study Contact Backup: Name: Jun Qi, MD; Phone Number: +86-021-25078080; Email: qijun@xinhuamed.com.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200092
      • Recruiting
      • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

• Patients with initial diagnosis of prostate cancer;
• Patients with biochemical recurrent prostate cancer;
• Patients with CRPC.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
18F-PSMA PET/CT imaging	The outcome of 18F-PSMA PET/CT imaging.	4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone scan imaging	The outcome of bone scan imaging.	6 hours
MRI imaging	The outcome of MRI imaging.	4 hours

Collaborators and Investigators

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Hongliang Fu, MD, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Anticipated): October 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: April 16, 2018
• First Submitted That Met QC Criteria: April 16, 2018
• First Posted (Actual): April 25, 2018

Study Record Updates

• Last Update Posted (Actual): April 25, 2018
• Last Update Submitted That Met QC Criteria: April 16, 2018
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: PET/CT; prostate cancer; prostate specific membrane antigen(PMSA)
• Additional Relevant MeSH Terms: Pathologic Processes; Urogenital Neoplasms; Neoplasms by Site; Disease Attributes; Genital Neoplasms, Male; Prostatic Diseases; Neoplasms; Prostatic Neoplasms; Recurrence
• Other Study ID Numbers: XH-17-020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No