This study was closed to accrual on 06/01/1999. Three patients had been enrolled at Johns Hopkins. One patient was enrolled to arm 3 involving radiation therapy to the whole pelvis followed by 4 months of Total Androgen Suppression. This patient had a complete response to treatment at his 3 month follow-up and remained disease free until 4 years post his last dose, at which time his PSA rose significantly and rapidly and an unpalpable tumor was present by CT. He was started on single agent Taxotere from which he initially improved symptomatically by the end of the first course. By the fourth course of treatment the patient clinically deteriorated and he was taken off treatment. He was maintained on single-agent Prednisone for chronic lower extremity edema and disease management. At his 5 year follow-up he was noted to have disease progression and was started on Cytoxan 100mg qd x 14 days. The patient unfortunately passed away in August of 2001 (a month after starting Cytoxan) due to progressive disease.
Two patients we enrolled on arm 4 which consists of radiation to the prostate only followed by 4 months of Total Androgen Suppression. One patient passed away in March of 1999 due to metastatic pancreatic cancer.
The second patient enrolled on arm 4 continues in follow-up, remaining disease free as of his 2 year follow-up.
The preliminary analysis demonstrates that Whole-Pelvic radiation is associated with improvement in progression-free survival compared to Prostate only radiation in patients with a risk of lymph node involvement > 15%. The failure to see an early advantage in progression free survival with neoadjuvant compared to adjuvant may result from the fact that the time from the date of randomization to discontinuation of Total Androgen Suppression. |
