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

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ClinicalTrials.gov Identifier: NCT03912883
Recruitment Status : Active, not recruiting
First Posted : April 11, 2019
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 3350 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Prognostic Factors in Prostate Cancer for Patients Treated by Watchful Waiting
Actual Study Start Date : October 12, 1999
Actual Primary Completion Date : January 2015
Estimated Study Completion Date : December 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Biospecimen Retention:   Samples With DNA
H&E slides and/or FFPE blocks


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 76 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
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.
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

Publications:

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Responsible Party: Queen Mary University of London
ClinicalTrials.gov Identifier: NCT03912883     History of Changes
Other Study ID Numbers: 005937
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Queen Mary University of London:
biomarkers
pathology
tissue
watchful waiting
active surveillance
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases