International Journal of Radiation Oncology published a 10-year post-treatment analysis of the German ARO 96-02 trial. It reported that prostate cancer patients with detectable prostate specific antigen (PSA) following radical prostatectomy should receive earlier, more aggressive radiation therapy treatment.
The German ARO 96-02 trial is a prospective clinical trial that compared a wait-and-see approach versus an adjuvant radiation therapy approach for patients with node negative prostate cancer who had a prostatectomy.
388 patients from 1997 to 2004 with pT3-4pN0 prostate cancer with positive or negative margins who had already undergone radical prostatectomy were ensued for ARO 96-02.
Twenty-two centers in Germany participated in the trial. 159 patients were randomized to a wait-and-see approach (Arm A) and 148 patients were randomized to receive adjuvant radiation therapy (Arm B). Seventy-eight patients who did not achieve an undetectable PSA were moved to Arm C. The overall survival (OS) rate and Clinical relapse-free survival determined the outcomes of the study.
Patients in Arm A had a 10-year ovearall survival rate of 86 percent, and patients in Arm B had a 10-year OS rate of 83 percent, compared with patients in Arm C who had a 10-year OS rate of 68 percent.
Clinical relapse-free survival of patients in Arm C for a ten year period was 63 percent.
All patients in the study had a pre- and post-operative PSA test, a bone scan and chest radiography. Patients in Arm B received 60 Gy of 3-D conformal radiation therapy. Patients in Arm C received 66 Gy of 3-D conformal radiation therapy.
"After patients undergo radical prostatectomy, the marker for PSA should fall below detection limits. Our analysis demonstrates that patients who have detectable PSA post-prostatectomy may benefit from more aggressive, early and uniform treatment that could improve survival outcomes," said Thomas Wiegel, MD, director of the radiation oncology department at University Hospital Ulm in Ulm, Germany, and lead author of the study.