ProtecT trial aims to answer questions regarding localized prostate cancer treatment
The Prostate testing for cancer and Treatment (ProtecT) randomized trial currently being conducted by British researchers will hopefully bring clarity to the debate on how to manage prostate-specific antigen- (PSA-) detected clinically localized prostate cancer.
Specifically, the trial will assess the effectiveness and cost-effectiveness of an active monitoring surveillance protocol; external beam conformal radiotherapy with neoadjuvant androgen suppression; and radical prostatectomy, according to J. Athene Lane, PhD, University of Bristol, U.K., and colleagues.
“The ProtecT trial is, to our knowledge, the largest contemporary randomised controlled trial investigating the effectiveness of conventional treatment options in men with clinically localised prostate cancer detected after PSA testing,” wrote Lane and colleagues in the September issue of Lancet Oncology.
For the study, nearly 229,000 men were invited to attend an appointment with a specialist nurse from Oct. 1, 2001, to Jan. 20, 2009. Many received a PSA test, those with a PSA concentration of 3.0—19.9 μg/L underwent biopsy, and 2,896 were eventually diagnosed with prostate cancer. Ultimately 1,643 agreed to be randomly assigned to one of the three treatment arms.
PSA measurement followed by biopsy can help in the early detection of disease, but most screen-detected cancers are at low risk of progression and most men diagnosed with PSA-detected prostate cancer undergo radical treatment. Previous trials have been split on the benefits of surgery for those with PSA-detected cancer, though the authors of ProtecT say the trial “clearly differs” from earlier efforts.
“The major findings will provide key information needed to underpin the management of clinically localised prostate cancer, including the crucial trade-off between survival gains and potential harm caused by over-detection and unnecessary radical treatment in PSA-detected prostate cancer,” they wrote.
Analysis of the primary outcome of disease-specific mortality is scheduled for 2016, at 10 years' median follow-up, according to Lane and colleagues.