Donovan J, Peters T; International Society of Technology Assessment in Health Care. Meeting.
Annu Meet Int Soc Technol Assess Health Care Int Soc Technol Assess Health Care Meet. 2000; 16: 098.
ProtecT group. Dept Social Medicine/MRC HSRC, University of Bristol, BS8 2PR; University of Sheffield; University of Newcastle; UK.
Introduction: While there is considerable interest in the suitability of localised prostate cancer (CaP) for population screening, there is a lack of evidence concerning the most effective treatments and concern that treatment trials cannot be mounted. We undertook the ProtecT (prostate testing for cancer and Treatment) study to examine the feasibility of establishing a three-arm randomised controlled trial comparing radical prostatectomy (RadP), radical radiotherapy (RadR), and conservative monitoring (CM), or a two-arm trial of the radical treatments, with preference patients also being followed up. Methods: Over 10,000 community-based men aged 50-70 years are being invited to attend a prostate check clinic at which a nurse explains the advantages/disadvantages of the treatments, the need for RCTs and the risks of having CaP. Consenting men have a PSA blood test. If results are abnormal, they undergo transrectal ultrasound and biopsy. Men with confirmed localised CaP are randomised to receive detailed information from a nurse or urologist who attempts to recruit them to the treatment trials. Results: To date, 1473 men have been invited to prostate check clinics. 749 (51%) attended and 692 had the PSA test. 55 (7% of attenders) had abnormal results. Localised CaP was confirmed in 7 men (13% of those with abnormal PSA, 0.5% of those invited). All agreed to be randomised to a nurse or urologist. Two have been randomised to RadP (one in the 3-arm and one in the 2-arm trial), one was randomised to RadR, one refused randomisation and opted for RadR, and one is currently undecided. Conclusions: This research (ongoing) has shown that it is possible to identify men with localised CaP in the community and to compare the cost-effectiveness of recruitment by a nurse or urologist. There is mixed reaction to randomisation for treatment, but thus far only one man has actively rejected it.
Publication Types:
Keywords:
- Adenocarcinoma
- Biopsy
- Carcinoma
- Clinical Trials as Topic
- Cost-Benefit Analysis
- Humans
- Male
- Mass Screening
- Prostate-Specific Antigen
- Prostatectomy
- Prostatic Neoplasms
- Randomized Controlled Trials as Topic
- Research Design
- diagnosis
- economics
- immunology
- surgery
- therapy
- hsrmtgs
Other ID:
UI: 102271770
From Meeting Abstracts