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

NCT03927287 | Completed

• 1 other identifier: 17-5498
• Study Type: observational
• Target: 822
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastasis; Castration-resistant Prostate Cancer; Death

Outcome Measures

Primary Outcomes (1)

• Metastasis free survival

  Rate of Metastasis correlated to the first post-treatment free PSA ratio

  From date of diagnosis to date of Metastasis development, assessed up to 200 months

Secondary Outcomes (2)

• Castrate resistant prostate cancer (CRPC) free survival

  From date of Diagnosis to date of CRPC development, assessed up to 200 months

• Cancer specific survival

  From date of diagnosis to date of cancer specific death, assessed up to 200 months

Study Arms (3)

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.

Radiotherapy cohort

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

Interventions

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

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

Biobank surgical cohort

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Must be men with prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• For the two retrospective cohorts:
• All patients that older than 18 treated for localized adenocarcinoma of the prostate between 2000 and 2017 with either radical prostatectomy or radiotherapy
• All treated patients had a rising post-treatment PSA, with at least one post-treatment free PSA blood test.
• For the biobank validation cohort:
• \. All patients treated with radical prostatectomy for localized prostate cancer between 2000 and 2017 who had biobank samples taken when developing biochemical recurrence.

You may not qualify if:

• Patients that were younger than 18,
• Patients with prostate cancer other than adenocarcinoma, such as small cell and neuroendocrine cancer
• Patients with prostate adenocarcinoma that did not develop biochemical recurrence.
• In the retrospective cohorts - patients that did not have at least one post-treatment free PSA blood test.

Sponsors & Collaborators

• Rabin Medical Center: lead
• University of Toronto: collaborator

Study Sites (1)

Princess Margaret Cancer Center

Toronto, Ontario, M5G2M9, Canada

Location

Related Publications (1)

• Goldberg H, Glicksman R, Woon D, Hoffman A, Shaikh H, Chandrasekar T, Klaassen Z, Wallis CJD, Ahmad AE, Sanmamed-Salgado N, Qu X, Moraes FY, Diamandis EP, Berlin A, Fleshner NE. Can post-treatment free PSA ratio be used to predict adverse outcomes in recurrent prostate cancer? BJU Int. 2021 Jun;127(6):654-664. doi: 10.1111/bju.15236. Epub 2020 Sep 26.

  PMID: 32926761 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis; Death

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Neil Fleshner, MD, MPH

  Princess Margaret Hospital, University Health Network

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 19, 2019
• First Posted: April 25, 2019
• Study Start: January 1, 2018
• Primary Completion: December 30, 2018
• Study Completion: April 10, 2019
• Last Updated: April 25, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)