Authors' objectives:

The overall aim was to evaluate the feasibility of a randomised controlled trial (RCT) of treatments for localised prostate cancer, including:

- feasibility of case-finding in the community (including the reliability and psychosocial impact of PSA testing)

- determining the most efficient and effective design for a major trial of treatments

- randomised trial of recruitment strategies

- piloting outcome measures and procedures for the main trial of treatments.

Authors' results and conclusions: Case-finding: A total of 8505 men from 18 primary care centres attended prostate check clinics (56% of those invited), and 7383 had a PSA test. Of these, 861 (12%) had raised PSA levels, and following biopsy, 224 cases of prostate cancer were found (165 clinically localised). The detection rate was 2.2% of clinic attendees. PPVs confirmed that a PSA cut-point of 3 ng/ml was suitable. At the time of PSA testing, levels of depression were low (3.2% cases) and anxiety somewhat higher (11.6% cases), but these remained virtually unchanged among those completing questionnaires at the time of biopsy. Randomised trial of recruitment: Ninety per cent of eligible cases consented to randomisation between a nurse and urologist. Urologists achieved a higher rate of recruitment to the treatment trial (71% compared with 67% for nurses), but this was not statistically significant (p=0.60). As effectiveness was essentially the same between the two arms, a cost-minimisation analysis was performed and showed that the urologist arm was more expensive because greater salary costs outweighed their tendency for shorter appointments and nurses often supported surgeon-led clinics. Randomised trial of treatment: The three-arm trial was the most popular treatment trial option, with 84% opting for this rather than the two-arm trial (p < 0.001). The acceptance of the treatment allocation was 71% within the three-arm trial. Qualitative research: The offer of PSA testing was construed as an opportunity to discover an unknown condition and the majority of men indicated that they understood that the study involved investigation of treatments. While the majority could recall clearly the principles of randomisation, issues around clinical equipoise caused many considerable difficulty. Recruitment to the treatment trial increased gradually during the feasibility study, from 30-40% at the outset to 70% by the end of the feasibility study. These improvements in recruitment were brought about by changes to the content and presentation of information, particularly avoidance of terms such as trial and watchful waiting, and the clear specification of the non-radical treatment arm, as directed by the findings of the qualitative research.

Authors' recommendations: It is feasible to mount a full-scale three-arm randomised trial of treatment for localised prostate cancer, preceded by a programme of case-finding in the UK. The full-scale three-arm Prostate Testing for Cancer and Treatment (ProtecT) randomised trial of treatment has now been commissioned by the NHS R&D Health Technology Assessment Programme. It will be undertaken in nine clinical centres in the UK, involving over 100,000 men, and recruitment will take 5 years, commencing September 2001.

Authors' methods: Randomised controlled trial

Project Status: Completed

URL for project: http://www.hta.ac.uk/1079

Year Published: 2003

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England, United Kingdom

Organisation Name: NIHR Health Technology Assessment programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk

Copyright: 2003 Queen's Printer and Controller of HMSO