Short-term outcomes of the prospective multicentre ‘Prostate Cancer Research International: Active Surveillance’ study
Article first published online: 8 OCT 2009
© 2009 THE AUTHORS. JOURNAL COMPILATION © 2009 BJU INTERNATIONAL
Volume 105, Issue 7, pages 956–962, April 2010
How to Cite
Van Den Bergh, R. C.N., Vasarainen, H., Van Der Poel, H. G., Vis-Maters, J. J., Rietbergen, J. B., Pickles, T., Cornel, E. B., Valdagni, R., Jaspars, J. J., Van Der Hoeven, J., Staerman, F., Oomens, E. H.G.M., Rannikko, A., Roemeling, S., Steyerberg, E. W., Roobol, M. J., Schröder, F. H. and Bangma, C. H. (2010), Short-term outcomes of the prospective multicentre ‘Prostate Cancer Research International: Active Surveillance’ study. BJU International, 105: 956–962. doi: 10.1111/j.1464-410X.2009.08887.x
- Issue published online: 4 MAR 2010
- Article first published online: 8 OCT 2009
- Accepted for publication 26 June 2009
- active surveillance;
- prostate cancer;
- watchful waiting
Study Type – Therapy (prospective cohort) Level of Evidence 2b
To evaluate the short-term outcomes of the prospective international Prostate Cancer Research International: Active Surveillance (‘PRIAS’) study (Dutch Trial Register NTR1718), as active surveillance (AS) for early prostate cancer might provide a partial solution to the current overtreatment dilemma in this disease.
PATIENTS AND METHODS
The first 500 (of >950) participants with asymptomatic T1c/T2 prostate cancer, with a prostate-specific antigen (PSA) level of ≤10.0 ng/mL, a PSA density of <0.2 ng/mL/mL, a Gleason score of ≤3 + 3 = 6, and one or two positive biopsy cores, were analysed. The follow-up protocol consisted of frequent PSA measurements, digital rectal examinations, and standard repeat biopsies (the first after 1 year). The primary outcome is survival free of active therapy; the secondary endpoints are reasons for stopping AS, findings in 1-year repeat biopsies, and outcomes after radical prostatectomy (RP).
Patients were included between December 2006 and July 2008. The median (25–75th percentile) follow-up after diagnosis was 1.02 (0.6–1.5) years. The 2-year survival rate free from active therapy was 73%. Of the 82 men who changed to active therapy during the follow-up, 68 (83%) did so based on the protocol. Of the 261 repeat biopsies available for analysis, 90 (34%) showed no cancer, while 57 (22%) showed a Gleason score of >6 or more than two positive biopsy cores. There was a relatively unfavourable PSA doubling time of 0–10 years in 53% (102/194) and 62% (33/53) of men with favourable and unfavourable re-biopsy results, respectively. After RP, four of 24 (17%) men had T3 disease and 12 (50%) had a Gleason score of >6.
AS seems feasible, but mortality outcomes are unknown. A strict follow-up protocol including standard 1-year repeat biopsies resulted in a quarter of men stopping AS after 2 years.