An important study looking at the treatment of early stage prostate cancer was published in the New England Journal of Medicine on Wednesday (http://www.nejm.org/doi/full/10.1056/NEJMoa1606220?query=featured_home#t=articleBackground ). The use of prostate-specific antigen (PSA) testing has dramatically increased the diagnosis of prostate cancer. Close to 181,000 cases of prostate cancer will be diagnosed in the US in 2016 and over 26,000 men will die of the disease. But many cases of this cancer will progress slowly and not lead to death. Studies have been trying to determine if some men can safely avoid radical treatments and their associated side effects and complications. This study looked at 3 different treatment approaches to men diagnosed with early prostate cancer: surgery (radical prostatectomy), radiotherapy and active monitoring/surveillance.
Here are the basics of the study:
· The study recruited men 50-69 years old in the UK
· 1643 men were diagnosed with localized prostate cancer and agreed to be in the study
· The men were followed for a median of 10 years
· The study looked at prostate-cancer mortality (deaths that were definitely or probably due to prostate cancer or its treatment) at a median of 10 years follow up. It found that death from prostate cancer remained low, at approximately 1%, irrespective of the treatment assigned.
· Of the 545 men assigned to the active monitoring/surveillance treatment arm, 291 men required intervention during the study (56 within 9 months of starting the study). 142 (49%) underwent surgery; 97 (33%) received radiotherapy according to the study protocol. The rest received non-protocol radiotherapy, brachytherapy (insertion of radioactive pellets into the prostate), or other treatment.
· The study also looked at mortality from all causes, rates of metastases, clinical progression of cancer, treatment failure and treatment complications.
· There was no difference in mortality from all causes between the three treatment groups
· 204 men had disease progression, including metastases. The incidence was highest in the active monitoring/surveillance group (112 men vs. 46 in the surgery group and 46 in the radiotherapy group).
· There were no deaths attributable to surgery, but 9 men had blood clots/cardiovascular complications; 14 required multiple blood transfusions for blood loss; 1 had rectal injury; 9 had anastomotic problems (leakage of urine into the body from a damaged ureter).
· One limitation of the study was a protocol that was developed almost 20 yrs ago (treatments and diagnostic techniques have evolved since then). Also the men will need to be followed for a longer period of time to determine if any difference in survival rates will emerge.
The study authors conclude: “At a median follow-up of 10 years, the ProtecT trial showed that mortality from prostate cancer was low, irrespective of treatment assignment. Prostatectomy and radiotherapy were associated with lower rates of disease progression than active monitoring; however, 44% of the patients who were assigned to active monitoring did not receive radical treatment and avoided side effects. Men with newly diagnosed, localized prostate cancer need to consider the critical trade-off between the short-term and long-term effects of radical treatments on urinary, bowel, and sexual function and the higher risks of disease progression with active monitoring, as well as the effects of each of these options on quality of life. Further follow-up of the ProtecT participants with longer-term survival data will be crucial to evaluate this trade-off in order to fully inform decision making for physicians and patients considering PSA testing and treatment options for clinically localized prostate cancer.”