Authors' objectives:

This report is a review of the clinical and cost-effectiveness of new and emerging technologies for early, localised prostate cancer. A systematic review was undertaken to identify new and emerging technologies and to evaluate clinical and cost-effectiveness through assessment of the best available evidence. The review aimed to assess clinical effectiveness in terms of survival, disease-free survival, quality of life (QoL), including complications and adverse events) and acceptability.

Authors' results and conclusions: The highest quality evidence identified [13 randomised controlled trials (RCTs)] evaluated the effectiveness of neoadjuvant hormonal therapy (NHT). No evidence of benefit was seen in terms of biochemical disease-free survival. One RCT and three case series evaluated adjuvant hormonal therapy (AHT). There was no evidence of benefit in terms of survival, but there was some conflicting evidence that higher risk patients may benefit. The largest number of studies, most of which were descriptive case series, reported results for brachytherapy. There was some evidence to suggest that brachytherapy may be more effective than standard treatments for lower risk patients, although less effective for intermediate- and high-risk patients, in terms of biochemical disease-free survival. Evidence in terms of complications was mixed. Lower quality evidence reported fewer complications than for standard treatments. Higher quality evidence suggested that disease-specific QoL for brachytherapy patients was lower than for patients receiving standard treatments. The review of 3D-CRT identified four RCTs evaluating treatment-related morbidity. 3D-CRT achieved significantly fewer gastrointestinal complications than standard radiotherapy. Evidence in the form of case series suggested that higher radiation doses achieved better disease control, although patient characteristics were often reported as independent indicators of control. The review of intensity-modulated conformal radiotherapy (IMRT) was based on several case series, the largest of which suggested that IMRT may reduce late gastrointestinal toxicity compared with 3D-CRT. The review of cryotherapy was based on case-series evidence which reported high rates of impotence. Owing to the paucity and poor quality of evidence identified for the remaining interventions (hormonal monotherapy, high-intensity focused ultrasound (HIFU), interstitial microwave thermal therapy (IMTT), transperineal radiofrequency interstitial tumour ablation (RITA), laser photocoagulation and gene therapy), conclusions regarding their clinical effectiveness cannot be drawn. The results of the clinical effectiveness review should be viewed in the context of the quality of the available evidence. Very few RCTs were identified, with the majority of included studies being descriptive case series, open to patient selection bias and measuring surrogate end-points with short-term follow-up. It is difficult therefore to draw conclusions on the relative benefits or otherwise of the newer technologies owing to the lack of substantive evidence of any quality and the lack of comparisons between the newer technologies and with standard treatments.

Authors' recommendations: Given the lack of high-quality clinical evidence with long-term follow-up and the uncertainty surrounding the assumptions in the economic analysis, the following areas are recommended for further research: - RCTs with sufficient follow-up to measure benefits in terms of overall survival to include QoL measurement to establish trade-offs between potential adverse events and benefits of treatment. - The identification of prognostic risk factors among men diagnosed with early prostate cancer. - QoL studies to compare the utility of health states among patients on active monitoring, patients receiving treatment and the comparable healthy population. - The relationship between surrogate end-points and survival. - The adoption of standard definitions for adverse events.

Authors' methods: Systematic review, economic evaluation

Project Status: Completed

Year Published: 2003

URL for published report: http://www.journalslibrary.nihr.ac.uk/hta/hta7330/#/abstract

URL for additional information: http://www.journalslibrary.nihr.ac.uk/hta/volume-7/issue-33

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: <p>2003 Queen's Printer and Controller of HMSO</p>