Prognostic Role of Free Psa Ratio at Biochemical Recurrence After Radical Treatments for Prostate Cancer (FPSAR)
|ClinicalTrials.gov Identifier: NCT03927287|
Recruitment Status : Completed
First Posted : April 25, 2019
Last Update Posted : April 25, 2019
|Condition or disease||Intervention/treatment|
|Metastasis Castration-resistant Prostate Cancer Death||Diagnostic Test: Free PSA ratio test in patients after definitive treatment for localized prostate cancer|
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.
|Study Type :||Observational|
|Actual Enrollment :||822 participants|
|Official Title:||An "Old" Biomarker That Can Learn New Tricks: Prognostic Role of Free Psa Ratio at Biochemical Recurrence After Radical Treatments for Prostate Cancer|
|Actual Study Start Date :||January 1, 2018|
|Actual Primary Completion Date :||December 30, 2018|
|Actual Study Completion Date :||April 10, 2019|
Radical prostatectomy (RP cohort)
Our institutional prostate cancer database was queried for all patients between 2000-2017 who had a biochemical recurrence (BCR) after radical prostatectomy (RP) (Total PSA>=0.2 ng/ml) and had at least one post-BCR free PSA ratio (FPSAR) blood test (RP cohort). FPSAR ascertainments were performed incidentally or reflexively (e.g. PSA in the range of 4-10 ng/ml, as per Institutional policy). If multiple FPSAR tests were performed, only the first FPSAR test was analyzed. otal PSA and Free PSA data was performed with the Abbott Architect analytical platform, according to the instructions of the manufacturer.
Our institutional database was queried or all patients between 2000-2017 who had a rising PSA after radiotherapy (RT) for intermediate- and high-risk prostate cancer, and at least one post-treatment free PSA ratio (FPSAR) blood test (RT cohort). As in the RP cohort, FPSAR was performed either incidentally or reflexively, and the first FPSAR test was used for the analyses. Total PSA and Free PSA data was performed with the Abbott Architect analytical platform, according to the instructions of the manufacturer.
Biobank surgical cohort
To validate our findings in the two retrospective cohorts (RP and RT), we analyzed a third cohort of prospectively collected biobank specimens of patients who underwent RP and developed biochemical recurrence(Biobank cohort). The retrieved samples were batched and tested for FPSAR levels to determine the results in lower PSA ranges and also to account for intrinsic analyte measurements variability in the retrospective cohorts. For his cohort we used the Roche Elecsys analytical platform, according to the instructions of the manufacturer.
Diagnostic Test: Free PSA ratio test in patients after definitive treatment for localized prostate cancer
Free PSA ratio blood test done on biobank samples of patients after radical prostatectomy who developed biochemical recurrence.
- Metastasis free survival [ Time Frame: From date of diagnosis to date of Metastasis development, assessed up to 200 months ]Rate of Metastasis correlated to the first post-treatment free PSA ratio
- Castrate resistant prostate cancer (CRPC) free survival [ Time Frame: From date of Diagnosis to date of CRPC development, assessed up to 200 months ]Rate of CRPC correlated to the first post-treatment free PSA ratio
- Cancer specific survival [ Time Frame: From date of diagnosis to date of cancer specific death, assessed up to 200 months ]Rate of Cancer specific survival correlated to the first post-treatment free PSA ratio
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927287
|Princess Margaret Cancer Center|
|Toronto, Ontario, Canada, M5G2M9|
|Study Director:||Neil Fleshner, MD, MPH||Princess Margaret Hospital, University Health Network|