A new large clinical trial funded by the National Cancer Institute has demonstrated the best approach to therapy for men with intermediaterisk, early-stage prostate cancer that can prolong survival. In comparing treatments for early-stage prostate cancer, investigators found strong evidence that short-term androgen-deprivation therapy (ADT) in combination with radiotherapy is more effective than radiation therapy alone for men with intermediate risk (Jones CU, et al. N Engl J Med. 2011;356:107-118).
This 212-center study included 1979 men with early-stage prostate cancer. All patients had localized prostate cancer and prostate-specific antigen (PSA) levels ≤20 ng/mL. Among the patients, 395 were black men, who are known to have greater rates of prostate cancer than other men.
Patients were randomly assigned to treatment with radiotherapy alone (N = 992; 197 black men) or to radiotherapy plus 4 months of ADT that consisted of drugs that block the natural production of testosterone (N = 987; 198 black men). Of note, previous studies have shown that short-term ADT improves survival among patients with later-stage prostate cancer.
The median follow-up in this study was 9.1 years. Results showed that short-term ADT plus radiotherapy significantly improved the 10-year overall survival (OS) compared with ra - diation therapy alone (62% vs 57%, respectively).
The addition of short-term ADT to radiation therapy led to significantly fewer prostate cancer–related deaths (4% vs 8%, respectively; P = .001). The benefits of short-term ADT were true for white and black men. In a later analysis looking at the patients by disease risk, participants were divided into 3 groups—high, intermediate, and low risk, using various variables, including PSA levels, tumor grade, and disease stage.
The patients with intermediate-risk benefited from the combination therapy, unlike those with low or high risk. In those with intermediate risk, the 10- year OS rate significantly increased from 54% with radiotherapy alone to 61% with the combination of shortterm ADT plus radiotherapy, and disease- specific death rate was reduced from 10% to 3%.
