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

Rabin Medical Center822 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

822

Conditions

Metastasis Castration-resistant Prostate Cancer Death

Interventions

Free PSA ratio test in patients after definitive treatment for localized prostate cancerDIAGNOSTIC_TEST

Free PSA ratio blood test done on biobank samples of patients after radical prostatectomy who developed biochemical recurrence.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: For the two retrospective cohorts: 1. All patients that older than 18 treated for localized adenocarcinoma of the prostate between 2000 and 2017 with either radical prostatectomy or radiotherapy 2. All treated patients had a rising post-treatment PSA, with at least one post-treatment free PSA blood test. For the biobank validation cohort: 1\. All patients treated with radical prostatectomy for localized prostate cancer between 2000 and 2017 who had biobank samples taken when developing biochemical recurrence. Exclusion Criteria: 1. Patients that were younger than 18, 2. Patients with prostate cancer other than adenocarcinoma, such as small cell and neuroendocrine cancer 3. Patients with prostate adenocarcinoma that did not develop biochemical recurrence. 4. In the retrospective cohorts - patients that did not have at least one post-treatment free PSA blood test.

Locations (1)

Princess Margaret Cancer Center

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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