MetastasisFPSARNCT03927287
Prognostic Role of Free Psa Ratio at Biochemical Recurrence After Radical Treatments for Prostate Cancer
An observational study of Metastasis and Castration-resistant Prostate Cancer, run by Rabin Medical Center at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastasis, Castration-resistant Prostate Cancer, Death
- What is being tested?
- Free PSA ratio test in patients after definitive treatment for localized prostate cancer
- How many people
- 822 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2018to 10 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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:
- 1. All patients treated with radical prostatectomy for localized prostate cancer between 2000 and 2017 who had biobank samples taken when developing biochemical recurrence.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Metastasis, Castration-resistant Prostate Cancer, Death
- Being tested
- Free PSA ratio test in patients after definitive treatment for localized prostate cancer
- Medical subject headings
- Neoplasm Metastasis, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free PSA ratio test in patients after definitive treatment for localized prostate cancerDiagnostic test
Free PSA ratio blood test done on biobank samples of patients after radical prostatectomy who developed biochemical recurrence.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Free PSA ratio test in patients after definitive treatment for localized prostate cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metastasis free survival
Rate of Metastasis correlated to the first post-treatment free PSA ratio
Measured: From date of diagnosis to date of Metastasis development, assessed up to 200 months
Secondary outcomes (2)
Castrate resistant prostate cancer (CRPC) free survival
Rate of CRPC correlated to the first post-treatment free PSA ratio
Measured: From date of Diagnosis to date of CRPC development, assessed up to 200 months
Cancer specific survival
Rate of Cancer specific survival correlated to the first post-treatment free PSA ratio
Measured: From date of diagnosis to date of cancer specific death, assessed up to 200 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start1 Jan 2018
- Primary completion30 Dec 2018
- Study completion10 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MetastasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 822 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto
- Responsible party
- Principal investigator, Hanan Goldberg, University of Toronto
- Investigators
- Neil Fleshner, MD, MPH, Study director, Princess Margaret Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03927287
- Sponsor's protocol ID
- 17-5498
- Acronym
- FPSAR
- Status last verified
- Apr 2019
- First submitted
- 19 Apr 2019
- Last updated
- 25 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32926761
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03927287
- Acronym / sponsor ID
- FPSAR / 17-5498
- Conditions
- Metastasis, Castration-resistant Prostate Cancer, Death
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 822 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- University of Toronto
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 10 Apr 2019 (actual)
- First posted
- 25 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Diagnostic Test: Free PSA ratio test in patients after definitive treatment for localized prostate cancerTo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
- 1. All patients treated with radical prostatectomy for localized prostate cancer between 2000 and 2017 who had biobank samples taken when developing biochemical recurrence.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Free PSA ratio test in patients after definitive treatment for localized prostate cancerFree PSA ratio blood test done on biobank samples of patients after radical prostatectomy who developed biochemical recurrence. | Diagnostic test | Biobank surgical cohort |
Primary outcome
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
2 secondary outcomes
Castrate resistant prostate cancer (CRPC) free survival
Time frame: From date of Diagnosis to date of CRPC development, assessed up to 200 months
Cancer specific survival
Time frame: From date of diagnosis to date of cancer specific death, assessed up to 200 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2019.
- Derived from this study: PubMed 32926761Goldberg 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil Fleshner, MD, MPH study director
Princess Margaret Hospital, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastasis and Castration-resistant Prostate Cancer, run by Rabin Medical Center at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metastasis free survival (time frame: From date of diagnosis to date of Metastasis development, assessed up to 200 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03927287, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2019.