Outline of the ProtecT study and its data and samples
There are three major current components to the study:
- The ProtecT randomised controlled trial (RCT) is evaluating the effectiveness, cost-effectiveness and acceptability of (a) active monitoring, (b) radical 3D conformal radiotherapy and (c) radical prostatectomy in men with clinically localised prostate cancer, identified through population-based PSA testing (see 2 below). The outcome data from the ProtecT trial, including flagging with NHS Central Registry for cancer and cause of death, will not be analysed until after the data set is closed in November 2015. Post-randomisation data will only be available after the publication of the primary and most secondary analyses during 2016. The study has a comprehensive cohort design in which all men with localised prostate cancer - randomised and selecting treatment – are followed up. Data from the non-randomised cohort are also embargoed.
- Men aged 50-69 years in and around nine UK centres were invited to PSA testing between 2000 and 2008. There are baseline data on c. 110,000 men, some with epidemiological data and others with biological samples (see 3 below). Epidemiological and clinical data are also available on the men with an initial PSA >3ng/ml and various other diagnostic tests. Men diagnosed with localised prostate cancer are followed up as part of the ProtecT trial (see 1 above). Analyses are encouraged but are only permitted in relation to prostate cancer.
- Men who provided research biological samples come under the ethics and governance processes of the ProMPT study which is investigating mechanisms of aetiology, progression and treatment in localised and advanced prostate cancer, based on and clinical/epidemiological data. Biological data include whole blood, plasma, serum and urine – which have been processed and stored. The samples relating to men with prostate cancer have restricted availability, but there are many samples available for analysis, and TMAs are being constructed. Analyses are encouraged but are only permitted in relation to prostate cancer.
Proposals for access to data or biological samples in or linked to the ProtecT study must be completed on the Approved Study Form which will be considered by the PIs and the ProtecT study co-ordinator.
Agreement with the Protect Publication and Authorship Policy (PDF, 288kB) is mandatory.
The ProtecT study is funded by the NIHR Health Technology Assessment programme.
International Standard Randomised Controlled Trial Number: ISRCTN20141297
Ethical approval has been given by Trent Multi-centre Research Ethics Committee.
Read about the ProtecT study on the Cancer Research UK website.