Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 550 for:    prostate cancer | ( Map: Canada )

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03927287
Recruitment Status : Completed
First Posted : April 25, 2019
Last Update Posted : April 25, 2019
Sponsor:
Collaborator:
University of Toronto
Information provided by (Responsible Party):
Hanan Goldberg, University of Toronto

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.

Condition or disease Intervention/treatment
Metastasis Castration-resistant Prostate Cancer Death Diagnostic Test: Free PSA ratio test in patients after definitive treatment for localized prostate cancer

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.


Layout table for study information
Study Type : Observational
Actual Enrollment : 822 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : December 30, 2018
Actual Study Completion Date : April 10, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort Intervention/treatment
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
Free PSA ratio blood test done on biobank samples of patients after radical prostatectomy who developed biochemical recurrence.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Must be men with prostate cancer
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927287


Locations
Layout table for location information
Canada, Ontario
Princess Margaret Cancer Center
Toronto, Ontario, Canada, M5G2M9
Sponsors and Collaborators
Rabin Medical Center
University of Toronto
Investigators
Layout table for investigator information
Study Director: Neil Fleshner, MD, MPH Princess Margaret Hospital, University Health Network

Layout table for additonal information
Responsible Party: Hanan Goldberg, Principal Investigator, University of Toronto
ClinicalTrials.gov Identifier: NCT03927287     History of Changes
Other Study ID Numbers: 17-5498
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Recurrence
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Disease Attributes
Pathologic Processes