Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    PHI | Prostate Cancer | France
Previous Study | Return to List | Next Study

Prostate Health Index for Prostate Cancer Diagnosis (PHI-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03151356
Recruitment Status : Completed
First Posted : May 12, 2017
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Tracking Information
First Submitted Date May 11, 2017
First Posted Date May 12, 2017
Last Update Posted Date August 14, 2019
Actual Study Start Date September 18, 2017
Actual Primary Completion Date September 19, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 11, 2017)
Intrinsic performances of Prostate Health Index in predicting prostate biopsy outcome [ Time Frame: When the results of all prostate biopsies will be available (approximately at 7 months after the beginning of the study) ]
Area under receiver operating curve (ROC) analysis; the ROC curve will be constructed from the values of the sensitivity and specificity of Prostate Health Index by comparison to the gold standard, i.e. prostate biopsy outcome (cancer or not).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prostate Health Index for Prostate Cancer Diagnosis
Official Title Value of Prostate Health Index for Prostate Cancer Diagnosis
Brief Summary

Prostate biopsies are the gold standard for prostate cancer (PCa) diagnosis. They are performed according to the results of the measurement of prostate-specific antigen (PSA) in the serum of patients with PCa suspicion. More than half of the prostate biopsies reveal eventually negative because of the poor specificity of prostate-specific antigen assay. The Prostate Health Index (PHI) is a new diagnostic tool that has been described as a good predictor of prostate biopsy outcome. No large study has been performed so far in France. This study aim to evaluate Prostate Health Index diagnostic performances in a large multicentric French cohort of patients undergoing prostate biopsies because of clinical and/or biological suspicion of prostate cancer.

Prostate Health Index will be measured in patients directed to prostate biopsies according to usual practices. Inclusion of 400 patients within 6 months in 12 French centers is expected. The ability of Prostate Health Index to predict prostate cancer at biopsy will be evaluated in terms of intrinsic and extrinsic diagnostic performances including sensitivity, specificity, predictive values, diagnostic accuracy, area under receiver operating curves and decision curve analyses.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients addressed for prostate biopsies because of prostate cancer suspicion: serum total Prostate Specific Antigen ≥ 4 ng/mL and/or abnormal digital rectal examination and/or first degree familial history of prostate cancer.
Condition Prostate Cancer
Intervention Device: Measurement of Prostate Health Index (PHI)
Use of a diagnostic tool to predict prostate biopsy outcome: measurement of total and free PSA as well as the [-2]proPSA and calculation of The Prostate Health Index according to the following formula: Prostate Health Index (PHI) = [p2PSA /fPSA] x √tPSA
Study Groups/Cohorts Patients
Patients addressed for prostate biopsies because of clinical and/or biological suspicion of prostate cancer.
Intervention: Device: Measurement of Prostate Health Index (PHI)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 12, 2019)
472
Original Estimated Enrollment
 (submitted: May 11, 2017)
400
Actual Study Completion Date October 19, 2018
Actual Primary Completion Date September 19, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Man ≥ 18 years old
  • Addressed for prostate biopsy because of serum total Prostate Specific Antigen ≥ 4 ng/mL and/or abnormal digital rectal examination and/or first degree familial history of prostate cancer
  • Agreeing to participate to the study

Exclusion Criteria:

  • Personal history of positive prostate biopsy (evidence of prostate cancer)
  • Personal history or evidence of prostate cancer based on clinical data (highly suspicious digital rectal examination (≥cT3) and/or serum total PSA ≥ 20 ng/mL and/or evidence for lymph node or bone metastases (retroperitoneal lymph nodes, bone lesions …)
  • Evidence for synchronous non-prostate cancer (current active treatment)
  • Adult protected by law
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03151356
Other Study ID Numbers 69HCL17_0203
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Hospices Civils de Lyon
Study Sponsor Hospices Civils de Lyon
Collaborators Not Provided
Investigators Not Provided
PRS Account Hospices Civils de Lyon
Verification Date August 2019