Objectives: The prostate-specific antigen nadir that indicates potential cure by radiotherapy has never been established. We determined this nadir level and used it to define precisely disease freedom after radiotherapy.
Methods: Combination radioactive 125I prostate implant followed by external-beam radiation was administered to 660 men with clinical Stage T1T2N0 prostate cancer. The average pretreatment prostate-specific antigen level (Tandem R Assay) was 11.7 ng/mL (median 8.0 ng/mL, range 0.3 to 188 ng/mL). To analyze these data, recurrence was defined as a prostate-specific antigen level rising above whatever nadir was achieved. The median follow-up is 42 months (range 12 to 150 months).
Results: Eighty-one percent of all men are calculated to achieve a prostate-specific antigen nadir of 0.5 ng/mL or less and to have a 5- and 10-year disease-free survival rate of 93% and 83%, respectively, as compared with a 5-year disease-free survival rate of 26% for those achieving a nadir of 0.6 to 1.0 ng/mL--a significant difference (P = 0.0001). All men with a nadir greater than 1.0 ng/mL ultimately failed treatment. Of 201 men with a minimum 5-year follow-up, 143 are disease-free and 140 (98%) achieved and maintained a nadir of 0.5 ng/mL or less.
Conclusions: For possible cure of prostate cancer with radiotherapy, a prostate-specific antigen nadir of 0.5 ng/mL or less should be achieved. With this nadir level, disease freedom after irradiation is defined as achievement and maintenance of a nadir of 0.5 ng/mL or less. A nadir greater than 0.5 ng/mL or subsequent increase above 0.5 ng/mL is defined as irradiation treatment failure. This definition may help resolve the controversy about the potential for cure of prostate cancer by irradiation.