Prognostic Factors in Prostate Cancer for Patients Treated by Watchful Waiting

Active, not recruiting

• Conditions: Prostate Cancer

• Registration Number: NCT03912883
• Lead Sponsor: Queen Mary University of London

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.

Study Timeline

• Study Start: 1999-10-12
• Study First Submitted: 2019-02-14
• Study First Submitted QC: 2019-04-10
• Study First Posted: 2019-04-11
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-21
• Primary Completion: 2030-01-01
• Study Completion: 2030-01-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 3350

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival	From date of inclusion to date of death from any cause, assessed up to 30 years.	Time from date of inclusion until death from any cause.
Disease-specific survival	From date of inclusion to date of death from prostate cancer, assessed up to 30 years.	Time from date of inclusion until death from prostate cancer.

Secondary Outcome Measures

Name	Time	Method
To evaluate ki-67-positive biomarker predictors of prognosis in early prostate cancer.	From date of inclusion to date of death from any cause, assessed up to 30 years.	Correlation of ki-67-positive cells compared to overall cancer-specific survival.
To evaluate ERG-ETV1 biomarker predictors of prognosis in early prostate cancer.	From date of inclusion to date of death from prostate cancer, assessed up to 30 years.	Correlation of ERG-ETV1 rearrangement status compared to prostate cancer-specific survival.
To evaluate a correlation between serum PSA level and prostate cancer-specific survival.	From date of inclusion to date of death from prostate cancer, assessed up to 30 years.	Correlation of serum PSA level taken within 6 months of date of inclusion compared to death from prostate cancer.
To evaluate an association between clinical stage and prostate cancer-specific survival.	From date of inclusion to date of death from any cause, assessed up to 30 years.	Stratification of clinical stage at date of inclusion compared to death from prostate cancer.
To evaluate a correlation between Gleason score and prostate cancer-specific survival.	From date of inclusion to date of death from prostate cancer, assessed up to 30 years.	Correlation of Gleason Score at date of inclusion compared to death from prostate cancer.