NCT03488706

Brief Summary

Prostate cancer screening with PSA is plagued by high rate of unnecessary prostate biopsies, especially in the "gray zone" (4.00ng/ml e 10.99ng/ml). We introduce a new circulating-tumor-cell (CTC) biomarker for detection of prostate cancer in patients in the PSA "gray zone" level, with the clinically verified potential to substantially decrease the number of unnecessary prostate biopsies.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 5, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2018

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2021

Completed
Last Updated

April 5, 2018

Status Verified

March 1, 2018

Enrollment Period

11 months

First QC Date

March 29, 2018

Last Update Submit

March 29, 2018

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Circulating tumor cells detection

    Using a circulating-tumor-cell (CTC) test to detect prostate cancer in patients in the PSA "gray zone" level

    Prior to prostate biopsy

Study Arms (1)

Gray Zone Group

The gray zone group PSA between 4.00 to 10.99 ng/ml.

Eligibility Criteria

Age20 Years - 99 Years
Sexmale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

PSA 4.00- 10.99 ng/ml patients

You may qualify if:

  • Subjects are willing to sign the informed consent and agree to comply with the study procedures.
  • Age from 20 to 99 years old
  • Subjects with a PSA 4.00- 10.99 ng/ml and will receive biopsy within 3 months

You may not qualify if:

  • Age \< 20 years
  • Refuse to sign the informed consent form
  • Received regional anesthesia and general anesthesia within one month
  • Previous cancer history
  • Autoimmune diseases
  • Chronic inflammatory diseases
  • Diagnosed with colorectal polyps or adenomas
  • Acute inflammatory or infectious diseases in three months
  • Other diseases decided by PI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linkou Chang Gung Memorial Hospital

Taoyuan, Taiwan

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Ying-Hsu Chang

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joy Chang

CONTACT

+886-2-26558455joy@cellmaxlife.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2018

First Posted

April 5, 2018

Study Start

January 17, 2018

Primary Completion

December 12, 2018

Study Completion

June 2, 2021

Last Updated

April 5, 2018

Record last verified: 2018-03

Locations

TW(1)