Prognostic Factors in Prostate Cancer for Patients Treated by Watchful Waiting (TAPG)

July 24, 2023 updated by: Queen Mary University of London
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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

3350

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-specific survival
Time Frame: 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.
From date of inclusion to date of death from prostate cancer, assessed up to 30 years.
Overall survival
Time Frame: 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.
From date of inclusion to date of death from any cause, assessed up to 30 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate a correlation between serum PSA level and prostate cancer-specific survival.
Time Frame: 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.
From date of inclusion to date of death from prostate cancer, assessed up to 30 years.
To evaluate a correlation between Gleason score and prostate cancer-specific survival.
Time Frame: 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.
From date of inclusion to date of death from prostate cancer, assessed up to 30 years.
To evaluate an association between clinical stage and prostate cancer-specific survival.
Time Frame: 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.
From date of inclusion to date of death from any cause, assessed up to 30 years.
To evaluate ki-67-positive biomarker predictors of prognosis in early prostate cancer.
Time Frame: From date of inclusion to date of death from prostate cancer, assessed up to 30 years.
Correlation of ki-67-positive cells compared to prostate cancer-specific survival.
From date of inclusion to date of death from prostate cancer, assessed up to 30 years.
To evaluate ki-67-positive biomarker predictors of prognosis in early prostate cancer.
Time Frame: 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.
From date of inclusion to date of death from any cause, assessed up to 30 years.
To evaluate ERG-ETV1 biomarker predictors of prognosis in early prostate cancer.
Time Frame: 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.
From date of inclusion to date of death from prostate cancer, assessed up to 30 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Mary University of London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 1999

Primary Completion (Actual)

January 1, 2015

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

February 14, 2019

First Submitted That Met QC Criteria

April 10, 2019

First Posted (Actual)

April 11, 2019

Study Record Updates

Last Update Posted (Actual)

July 25, 2023

Last Update Submitted That Met QC Criteria

July 24, 2023

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 005937

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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