Clinical trial NCT03927287: Prognostic Role of Free Psa Ratio at Biochemical Recurrence After Radical Treatments for Prostate Cancer
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastasis
Castration-resistant Prostate Cancer
Death
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
Collaborators: name: University of Toronto
First posted: 2019-04-25
Enrollment: 822
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Metastasis free survival
timeFrame: From date of diagnosis to date of Metastasis development, assessed up to 200 months
Secondary outcomes:
measure: Castrate resistant prostate cancer (CRPC) free survival
timeFrame: From date of Diagnosis to date of CRPC development, assessed up to 200 months
measure: Cancer specific survival
timeFrame: From date of diagnosis to date of cancer specific death, assessed up to 200 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Center
state: Ontario
Study officials:
affiliation: Princess Margaret Hospital, University Health Network
name: Neil Fleshner, MD, MPH
role: STUDY_DIRECTOR
References:
citation: 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.