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

Death Clinical Trial

— FPSAR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03927287
• Other study ID #: 17-5498
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: April 10, 2019

Study information

• Verified date: April 2019
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 822
• Est. completion date: April 10, 2019
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Castration-resistant Prostate Cancer
• Death
• Metastasis
• Prostatic Neoplasms
• Recurrence

Intervention

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.

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Center	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Rabin Medical Center	University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Castrate resistant prostate cancer (CRPC) free survival	Rate of CRPC correlated to the first post-treatment free PSA ratio	From date of Diagnosis to date of CRPC development, assessed up to 200 months
Secondary	Cancer specific survival	Rate of Cancer specific survival correlated to the first post-treatment free PSA ratio	From date of diagnosis to date of cancer specific death, assessed up to 200 months