follow up. In two patients, hematuria was chronic and presented inter- mittently despite interventions. No grade 4 hemorrhagic cystitis was observed. Four patients (3.6%) experienced grade 2 urinary inconti- nence (spontaneous, pads indicated), presented at a median time of 11.5 months after treatment and resolved at a median of 1 year. Grade 2 rectal bleeding was observed in 6% of this cohort which presented at a median time of 1 year after treatment and its average duration before resolution was 3.8 years. No patients experienced grade 3 rectal bleeding. For rectal incontinence, 4 patients (3.6%) developed grade 1 rectal incontinence at a median delay of 3.5 yrs and 2 patients (1.8%) developed grade 2 rectal incontinence at a median delay of 7.8 years after RT. One patient had a grade 2 urethral stricture at the 10 year follow up and this was successfully treated. The median onset of grade 2 and higher rectal and urinary complications were 2 and 3 years, respectively. Only 12 patients (11%) manifested with a urinary or rectal complication after 10 years of follow up and these were generally transient. CONCLUSIONS: Excellent tolerance of conformal radiotherapy is observed beyond 10 years from therapy. Manifestations of compli- cations beyond 10 years is uncommon and such events in this cohort were generally transient. These data dispel the notion that significant complications develop beyond 10 years after radiotherapy. Source of Funding: None 674 DELAYED PSA RESPONSES IN PERSONALIZED PEPTIDE VACCINATION FOR CASTRATE-RESISTANT PROSTATE CANCER PATIENTS: PHASE II STUDY Masanori Noguchi*, Fukuko Moriya, Shigetaka Suekane, Kei Matsuoka, Satoko Matsueda, Tetsuro Sasada, Akira Yamada, Kyogo Itoh, Kurume, Japan INTRODUCTION AND OBJECTIVES: Personalized peptide vaccine (PPV) is a multiple peptide vaccine regimen planned according to the pre-existing immunity that could prolong overall survival (OS) of patients with castrate-resistant prostate cancer (CRPC). The purpose of this study was to prospectively assess the efficacy, safety and biomarkers of the PPV in CRPC patients. METHODS: This study was a non-randomized, open-label, phase II study of patients with CRPC. Participants were treated with PPV using positive peptides chosen from 31 peptides in patients with positive human leukocyte antigen (HLA)-A24, -A2, A26, -A3 super- type, respectively. Peptide-reactive immunoglobulin G (IgG) using an enzyme-linked immunosorbent assay was monitored during every 6th vaccination. The association between immunological responses, ex- pected prognostic factors including age, performance status (PS), lymphocyte counts, prostate-specific antigen (PSA), PSA doubling time, C-reactive protein (CRP), serum amino acid, interleukin -6, prior chemotherapy status and IgG responses, and overall survival was studied. RESULTS: One hundred patients with CRPC received PPV and median times of vaccination was 15.5 (range; 5 to 38). The peptide vaccination was safe and well tolerated with no major adverse effects during PPV in all patients. Increases of the anti-peptide IgG titer were revealed in 42/90 (47%) patients tested at the 6th vaccination. Con- firmed PSA decline 50% was observed in 21% of the patients, median time to PSA decline was 6.4 months and median duration of PSA decline was 4.2 months. Median OS time was 17.1 months in all patients. Multivariate Cox proportional hazard regression analysis showed that baseline PS status, PSA and CRP levels are independent prognostic factors. CONCLUSIONS: PPV in patients with CRPC is active and well tolerated improving survival with delayed PSA responses. Activity was observed in patients with good PS status, low PSA and CRP levels. Further randomized trials are needed to confirm our preliminary results. Source of Funding: None 675 FIVE YEAR OUTCOMES OF SALVAGE CRYOTHERAPY FOR LOCALLY RECURRENT PROSTATE: UPDATE FROM THE COLD REGISTRY Philippe E. Spiess*, David Levy, Tampa, FL; Louis L. Pisters, Houston, TX; J. Stephen Jones, Cleveland, OH INTRODUCTION AND OBJECTIVES: One of the major limita- tions in the prostate cancer salvage therapy literature pertains to the lack of long-term data in terms of the oncological efficacy of salvage cryotherapy. The aim of the present study was to assess the long-term results of salvage cryotherapy for patients with locally recurrent pros- tate cancer following primary radiotherapy. METHODS: A prospectively, centrally collected secure online database has been developed of patients undergoing salvage cryoab- lation for locally recurrent prostate cancer. Long-term results were available on 132 patients who underwent whole gland salvage cryo- therapy with: (1) curative intent, (2) in the absence of neoadjuvant/ adjuvant hormonal ablative therapy, and (3) all had extended serial PSA follow-up data. The mean follow-up of this patient cohort was 4.3 years. RESULTS: The mean age of patients at presentation was 70.1 years (+6.6 years). The majority of patients had a pre-treatment PSA 10 ng/ml, a biopsy Gleason score 8, and a clinical stage T2b (81%, 83%, and 85%; respectively). The 1, 2, and 5 year actuarial biochem- ical disease-free survival rates using the Phoenix definition (nadir + 2 ng/ml) were 87.8%, 72.4%, and 45.5%, respectively. At one year following salvage cryotherapy, urinary retention developed in 4.6% and urinary fistulas in 0.7% of patients. Of our study population, a nadir PSA (post-cryotherapy) 0.1 ng/ml was reached in 47 (35.6%), between 0.1 and 0.6 ng/ml in 30 (29.8%), between 0.6 and 2.5 ng/ml in 27 (20.5%), and 2.5 ng/ml in 19 (14.4%). A Kaplan Meier analysis of biochemical disease-free survival using the Phoenix definition stratified by the nadir PSA reached post-salvage cryotherapy is shown in the Figure. CONCLUSIONS: The long-term oncological results of salvage cryoablation are encouraging and support the curative potential of this salvage modality in appropriately selected patients. The nadir PSA reached post-salvage cryotherapy is strongly predictive of the subse- quent risk of biochemical disease-free survival. Source of Funding: The COLD Registry is sponsored by an unrestricted research grant from Endocare. Data are held and analyzed by Watermark, an independent research company under the direction of an independent physician board. Vol. 187, No. 4S, Supplement, Sunday, May 20, 2012 THE JOURNAL OF UROLOGYe275