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OpenTrials
Completed

NCT Number: NCT03927287

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Princess Margaret Cancer Center

Toronto, Ontario, M5G2M9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Collaborators

  • University of Toronto

Registry information

Official study title

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

Acronym: FPSAR

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Apr 25, 2019
Registry last updated
Apr 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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