Wolfson Institute of Preventive Medicine - Barts and The London

Prognostic Factors in Prostate Cancer for Patients Treated by Watchful Waiting conducted by the Transatlantic Prostate Group (TAPG)

Centre for Cancer Prevention

Funding Body:  Memorial Sloan Kettering Cancer Centre, SPORE, CRUK

Project Investigator:  Professor Jack Cuzick

Overview

Prognostic Factors in Prostate Cancer for Patients Treated by Watchful Waiting, conducted by the Transatlantic Prostate Group (TAPG) is a long-term retrospective epidemiology cohort study on factors predicting clinical progression of prostate cancer.

Study Design

The TAPG study is the long-term follow-up that started in 1999. It comprises approximately 3,300 men diagnosed with prostate cancer between 1990 and 2006. This exploratory study aims to identify prognostic markers that will more accurately predict the probability of recurrence and allow for better patient selection for radical treatment of prostate cancer.

There is no direct patient involvement as this is a retrospective study carried out in patients registered on UK regional cancer databases, as having prostate cancer diagnosed between 1990 and 2006 inclusively.

Hospital sites participating in the TAPG study send pathology tissue biopsy slides and blocks to the Central Coordinating Team at the Centre for Cancer Prevention. These slides and blocks are analysed by the study reference pathologist and undergo biomarker testing to determine what factors can better predict clinical progression of prostate cancer. At the end of the study, the slides and blocks will be returned to the originating hospital sites.

National cancer registries or health information centres such as the Scottish Cancer registry, Public Health England and NHS Digital provide the Central Coordinating team with follow-up information on the patients included in the study.

There are no trial drugs or treatments associated with this observational study.

Objectives

In men diagnosed with prostate cancer and treated by radical prostatectomy or watchful waiting, the standard clinical factors (such as Prostate Specific Antigens (PSA), clinical stage, and Gleason Grade) have been shown to predict the probability of recurrence with modest accuracy. The TAPG study aims to develop a prognostic model for the prediction of death from prostate cancer after conservative treatment of prostate cancer using standard factors (PSA, clinical grade, Gleason grade). Secondly, it aims to determine whether prediction of disease recurrence can be improved by the addition of other pathological, biological or molecular markers to the standard clinical factors.

The data collected as part of the TAPG study will help assess the effectiveness of the interventions that prostate cancer patients receive and will substantially aid the decision-making process for the treatment of early prostate cancer, allowing better patient selection for radical therapy.


Inclusion Criteria

The main inclusion criteria includes:

  • Patients diagnosed with prostate cancer aged 18-76 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 prostate cancer

Patient Confidentiality

Queen Mary University of London will also collect information about TAPG study participants from NHS Digital, as well as other devolved public health bodies. This information will include participant name, date of birth, NHS number, and post code and health information, which is regarded as a special category of information. We will use these data to help assess the effectiveness of the trials’ interventions.

As Data Controller, Queen Mary University of London (QMUL) is responsible for the collection, storage and processing of these data for the study. These data include the following identifiable data, categorised under the General Data Protection Regulation (GDPR) as personal and sensitive:

  1. Cancer incidence (any diagnosis of cancer and the type of cancer it is)
  2. Mortality Data (in the event of death we will receive information confirming the date and cause of death)

The level of data collected from NHS/public health bodies will only be identifiable to us at QMUL and will not be shared with any third parties. Only authorised staff at the TAPG Coordinating Centre are able to access the data and only for specific purposes related to the trial. The data is stored in a secure, restricted-access environment. The data will be retained until destruction at the end of the study archiving period, which will be in 2050.

The legal bases for processing this data are exemption from Section 251 of the NHS Act 2006, as well as Article 6(1)(e) ‘performance of a task carried out in the public interest’ and Article 9(2)(j) ‘public interest, scientific or historical research purposes or statistical purposes’ pursuant to the GDPR.

As a University we use personally-identifiable information to conduct research to improve health, care and services. As a publicly-funded organisation, we have to ensure that it is in the public interest when we use personally-identifiable information from people who have agreed to take part in research. This means that when you agree to take part in a research study, we will use your data in the ways needed to conduct and analyse the research study. Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.

Health and care research should serve the public interest, which means that we have to demonstrate that our research serves the interests of society as a whole. We do this by following the UK Policy Framework for Health and Social Care Research.

If you wish to raise a complaint on how we have handled your personal data, you can contact our Data Protection Officer (data-protection@qmul.ac.uk) who will investigate the matter. If you are not satisfied with our response or believe we are processing your personal data in a way that is not lawful you can complain to the Information Commissioner’s Office (ICO).

 If you would like any further information about the TAPG epidemiological study, please contact the TAPG Central Coordinating Office by telephone 020 7882 5973 or by e-mail tapg@qmul.ac.uk.   

 

Additional Information

Ahmad AS, Vasiljević N, Carter P, et al. A novel DNA methylation score accurately predicts death from prostate cancer in men with low to intermediate clinical risk factors. Oncotarget. 2016;7(44):71833-71840. doi:10.18632/oncotarget.12377.

 

Attard G, Clark J, Ambroisine L, et al. Heterogeneity and clinical significance of ETV1 translocations in human prostate cancer. British Journal of Cancer. 2008;99(2):314-320. doi:10.1038/sj.bjc.6604472.

 

Berney DM, Gopalan A, Kudahetti S, et al. Ki-67 and outcome in clinically localised prostate cancer: analysis of conservatively treated prostate cancer patients from the Trans-Atlantic Prostate Group study. British Journal of Cancer. 2009;100(6):888-893. doi:10.1038/sj.bjc.6604951.

 

Berney DM, Fisher G, Kattan MW, et al. Major shifts in the treatment and prognosis of prostate cancer due to changes in pathological diagnosis and grading. BJU international. 2007;100(6):1240-1244. www.summon.com. doi: 10.1111/j.1464-410X.2007.07199.x.

 

Cuzick J, Stone S, Fisher G, et al. Validation of an RNA cell cycle progression score for predicting death from prostate cancer in a conservatively managed needle biopsy cohort. British Journal of Cancer. 2015;113(3):382-389. doi:10.1038/bjc.2015.223.

 

Cuzick J, Yang ZH, Fisher G, et al. Prognostic value of PTEN loss in men with conservatively managed localised prostate cancer. British Journal of Cancer. 2013;108(12):2582-2589. doi:10.1038/bjc.2013.248.

 

Cuzick J, Berney DM, Fisher G, et al. Prognostic value of a cell cycle progression signature for prostate cancer death in a conservatively managed needle biopsy cohort. British Journal of Cancer. 2012;106(6):1095-1099. doi:10.1038/bjc.2012.39.

 

Cuzick J, Swanson GP, Fisher G, et al. Prognostic value of an RNA expression signature derived from cell cycle proliferation genes for recurrence and death from prostate cancer: A retrospective study in two cohorts. The lancet oncology. 2011;12(3):245-255. doi:10.1016/S1470-2045(10)70295-3.

 

Cuzick J, Fisher G, Kattan MW, et al. Long-term outcome among men with conservatively treated localised prostate cancer. British Journal of Cancer. 2006;95(9):1186-1194. doi:10.1038/sj.bjc.6603411.

 

Fisher G, Yang ZH, Kudahetti S, et al. Prognostic value of Ki-67 for prostate cancer death in a conservatively managed cohort. British Journal of Cancer. 2013;108(2):271-277. doi:10.1038/bjc.2012.598.

 

Reid AHM, Attard G, Ambroisine L, et al. Molecular characterisation of ERG, ETV1 and PTEN gene loci identifies patients at low and high risk of death from prostate cancer. British Journal of Cancer. 2010;102(4):678-684. doi:10.1038/sj.bjc.6605554.