Clinical Trials Directory

Trials / Completed

CompletedNCT03927287

Prognostic Role of Free Psa Ratio at Biochemical Recurrence After Radical Treatments for Prostate Cancer

An "Old" Biomarker That Can Learn New Tricks: Prognostic Role of Free Psa Ratio at Biochemical Recurrence After Radical Treatments for Prostate Cancer

Status
Completed
Phase
Study type
Observational
Enrollment
822 (actual)
Sponsor
Rabin Medical Center · Academic / Other
Sex
Male
Age
18 Years
Healthy volunteers
Not accepted

Summary

Measurement of Free PSA ratio in patients after definitive radical treatment for prostate cancer, and assessment of whether post-treatment free PSA ratio can function as a biomarker for advanced disease in prostate cancer patients.

Detailed description

Prostatic specific antigen (PSA) circulates mostly in complex with protease inhibitors, but 10-30% circulates as inactive free-PSA (FPSA). In patients with prostate cancer (PCa), pretreatment FPSA is lower and used to risk-stratify patients for biopsy. However, posttreatment FPSA ratio (FPSAR) is rarely quantified, with an unexplored clinical value. Methods The institutional database was queried to identify patients following radical prostatectomy (RP cohort) or radiotherapy (RT cohort) between 2000 and 2017. For validation, the investigators identified an independent prospective cohort with biochemical recurrence (BCR) after RP, using biobank samples (biobank cohort). All patients had at least one posttreatment FPSAR test. Kaplan-Meier (KM) method was used to compare the metastasis-free (MFS), castration-resistant PCa (CRPC)-free, and cancer-specific-survival (CSS) rates. Multivariable Cox models determined the association between posttreatment FPSAR, metastases, and CRPC.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTFree PSA ratio test in patients after definitive treatment for localized prostate cancerFree PSA ratio blood test done on biobank samples of patients after radical prostatectomy who developed biochemical recurrence.

Timeline

Start date
2018-01-01
Primary completion
2018-12-30
Completion
2019-04-10
First posted
2019-04-25
Last updated
2019-04-25

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT03927287. Inclusion in this directory is not an endorsement.