3. Results
toxicity, Toxicity
DISEASE PROGRESSION
Patients: Of the 46 patients that displayed a benefit from the initial 6 months of therapy (in terms of stabilization/decrease of PSA, and/or improvement of PSADT, and with negative scans) and that were eligible for the second phase of an additional 12 months of therapy (to create a total of 18 months of treatment), 7 patients withdrew consent during the first month of the additional year of therapy and chose to continue the effective therapy independently, out of pocket, due to the travel distance to monthly medical visits. Thus, 39 patients were treated as per the protocol for a total of 18 months of treatment. Patient pre-treatment characteristics are summarized in Long-term outcome as determined by PSA level, PSADT, and disease progression: Out of the 39 patients that entered the second phase of the study (the additional 12 months of therapy, creating a total of 18 months), 85% (The benefits of 18 months of therapy in terms of PSA stabilization or decrease and/or PSADT lengthening were seen in all PSADT risk groups (Toxicity and compliance: None of the patients had grade 3/4 toxicity during the 18 months of therapy. Grade 1 toxicity was observed in 30% (