An observational study in Metastasis, Castration-resistant Prostate Cancer and Death, sponsored by Rabin Medical Center. Completed at 1 site in Canada. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-25.
Sponsored by Rabin Medical Center · Observational
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.
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.
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All patients in Princess Margaret Cancer treated for localized adenocarcinoma of the prostate between 2000 and 2017 with either radical prostatectomy or radiotherapy with a rising post-treatment PSA, who had at least one post-treatment free PSA blood test.
For the two retrospective cohorts:
For the biobank validation cohort:
Exclusion Criteria:
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.
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
Rate of Metastasis correlated to the first post-treatment free PSA ratio
Time frame: From date of diagnosis to date of Metastasis development, assessed up to 200 months
Castrate resistant prostate cancer (CRPC) free survival
Rate of CRPC correlated to the first post-treatment free PSA ratio
Time frame: From date of Diagnosis to date of CRPC development, assessed up to 200 months
Cancer specific survival
Rate of Cancer specific survival correlated to the first post-treatment free PSA ratio
Time frame: From date of diagnosis to date of cancer specific death, assessed up to 200 months
Plan to share: No
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