Clinical trial NCT03912883: Prognostic Factors in Prostate Cancer for Patients Treated by Watchful Waiting
Official title: Prognostic Factors in Prostate Cancer for Patients Treated by Watchful Waiting
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Prostate Cancer
Keywords: biomarkers
pathology
tissue
watchful waiting
active surveillance
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
First posted: 2019-04-11
Enrollment: 3350
Sex: MALE
Minimum age (years): 18
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a retrospective, exploratory cohort study and will be carried out in patients registered on UK regional cancer registry databases, as having been diagnosed with prostate cancer between 1990 and 2006, inclusive.

Brief summary: The Trans-Atlantic Prostate Group (TAPG) was established to examine the hypothesis that through a detailed retrospective analysis of outcome in a group of men with clinically localised prostate cancer at diagnosis, variables such as biological, pathological and clinical markers, could be identified that might accurately predict the prognosis of clinically localised prostate cancer.

Detailed description: In 1999, the TAPG group initiated the "Prognostic Factors in Prostate Cancer for Patients Treated by Watchful Waiting" study, referred to as the TAPG study. It is a retrospective population-based tissue sample study in men diagnosed with localised prostate cancer 1990-2006, inclusively. Initially the cohort comprised men diagnosed with prostate cancer with transurethral resection of the prostate (TURP) and needle biopsies 1990-1996, but was expanded from 2005 to include men diagnosed with prostate cancer 1990 - 2006. Data was collected from six regional cancer registries and eligibility was confirmed via hospital sites, which sent the relevant tissue samples to the TAPG Central Coordinating Office (CCO). Selection of eligible patients for the study completed in 2010. Since this year the TAPG CCO has been collecting cancer registration and mortality updates on the cohort members from regional cancer registries.

Eligibility criteria: Inclusion Criteria:

* Patients must be aged less than 76 years at the time of diagnosis
* Patients must have had a baseline serum PSA level measured before starting any treatment and within six months of diagnosis
* Patients must have been diagnosed between 1990 and 2006 with a clinically localized (clinical stage T1-T3, N0 or NX, MO or MX) prostate cancer, in the judgment of the treating physician
* The initial diagnostic biopsy sample must be available for review. Patients should have (but are not required to have) tissue blocks available for review.
* There must be no evidence of metastatic disease
* While data collection will include review of the reports of any imaging studies of the prostate, bones, or soft tissues, these studies are not essential
* Each patient should have had an adequate medical evaluation to document the status of disease for the first five years after diagnosis. Follow-up should include an annual PSA and digital rectal examination. Records will be reviewed to seek all information about medical evaluation after the time of diagnosis.

Exclusion Criteria:

* Patients older than 76 years at the time of diagnosis
* Patients who have not had a baseline serum PSA level measured before starting any treatment
* Patients who do not have the initial diagnosis biopsy sample for review
* Patients with evidence of metastatic disease

Primary outcomes:
measure: Disease-specific survival
timeFrame: From date of inclusion to date of death from prostate cancer, assessed up to 30 years.
measure: Overall survival
timeFrame: From date of inclusion to date of death from any cause, assessed up to 30 years.
Secondary outcomes:
measure: To evaluate a correlation between serum PSA level and prostate cancer-specific survival.
timeFrame: From date of inclusion to date of death from prostate cancer, assessed up to 30 years.
measure: To evaluate a correlation between Gleason score and prostate cancer-specific survival.
timeFrame: From date of inclusion to date of death from prostate cancer, assessed up to 30 years.
measure: To evaluate an association between clinical stage and prostate cancer-specific survival.
timeFrame: From date of inclusion to date of death from any cause, assessed up to 30 years.
measure: To evaluate ki-67-positive biomarker predictors of prognosis in early prostate cancer.
timeFrame: From date of inclusion to date of death from prostate cancer, assessed up to 30 years.
measure: To evaluate ki-67-positive biomarker predictors of prognosis in early prostate cancer.
timeFrame: From date of inclusion to date of death from any cause, assessed up to 30 years.
measure: To evaluate ERG-ETV1 biomarker predictors of prognosis in early prostate cancer.
timeFrame: From date of inclusion to date of death from prostate cancer, assessed up to 30 years.
Other outcomes:
Locations:
Study officials:
References:
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