Evaluation of the Metastasis and Recurrence of Prostate C... | NCT03507595

Studies
Evaluation of the Metastasis and Recurrence of Prostate Cancer

NCT03507595

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Status

Unknown status

Last Update Posted

Apr 25, 2018Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2017Actual

Primary Completion Date

Oct 31, 2019Estimated

Completion Date

Dec 31, 2019Estimated

First Submitted Date

Apr 16, 2018

First Submission Date that Met QC Criteria

Apr 16, 2018

First Posted Date

Apr 25, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2018

Last Update Posted Date

Apr 25, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Aged male

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hui Wang, MD	Contact	+86-021-25076980		wanghuishanghai@hotmail.com
Jun Qi, MD	Contact	+86-021-25078080		qijun@xinhuamed.com.cn

Overall Officials

Name	Affiliation	Role
Hongliang Fu, MD	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Recruiting	Shanghai	Shanghai Municipality	200092	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D011471	Prostatic Neoplasms
D004194	Disease

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms