Clinical Prostate Cancer

Cryosurgery of the prostate presents as an efficient therapy following failed radiation therapy. We report on a 7-year retrospective analysis evaluating the morbidity and biochemical disease-free survival (bDFS) of this therapy. Between 1993 and 2001, 59 patients who had been previously treated with radiation therapy and had rising serum prostate-specific antigen (PSA) values underwent salvage cryoablation of the prostate for localized, histologically proven, recurrent prostate cancer. Serial serum PSA testing was performed, and biopsies were taken at 6, 12, and 24 months, and again at 5 years, and any time the PSA rose above 0.5 ng/mL. Patients were stratified along clinical parameters. The combined postsalvage bDFS rate using a PSA cutoff of 0.5 ng/mL was 59% and 69% with a 1.0 ng/mL PSA cutoff. Using a PSA threshold of 0.5 ng/mL as evidence of biochemical recurrence, 61%, 62%, and 50% of patients with < 4 ng/mL, 4-10 ng/mL, and > 10 ng/mL PSA, respectively, remain biochemically relapse free at 7 years. A threshold of 1.0 ng/mL yielded a disease-free status of 78%, 74%, and 46%, respectively. Patient biopsies showed no evidence of residual or recurrent disease. Improved survival rates and no known latent complications indicate cryosurgery is a promising form of treatment for radiation-resistant prostate cancer. This 7-year analysis shows a promising validation of cryosurgery as an efficacious treatment modality for locally confined T1-T3 prostate cancer following primary radiation therapy failure. Abstrac

Primary cryoablation for Gleason 8, 9, or 10 localized prostate cancer: Biochemical and local control outcomes from the Cryo OnLine database registry

Introduction and Objective: The increased use of cryoablation as an initial treatment for localized high-grade prostate cancer has been due to many factors including reports that cell kill from exposure to cryogenic temperatures is independent of cellular dedifferentiation and Gleason score. The objective of this study is to report the outcomes of primary cryoablation when used to treat Gleason 8, 9, or 10 localized prostate cancer at a large number of centers. Materials and Methods: Data from 1608 patients who underwent primary cryoablation at 27 centers were collected using the Cryo OnLine Database (COLD) registry. This analysis considers only the 77 patients who had a Gleason score of at least 8 and a minimum of 24 months of follow-up. Biochemical failure was defined according to both the original ASTRO definition (three rises) and the 2006 updated ASTRO (Phoenix) definition of nadir + 2. Biopsy was performed at the physician′s discretion, but most commonly if a patient had a rising or suspicious prostate specific antigen (PSA). Results: The average age at treatment was 69.6 ± 8.2 years. Pretreatment PSA was 16.2 ± 17.9 ng/ml and the average Gleason was 8.5 ± 0.6. Patients were followed for 39.0 ± 18.8 months (range: 24-120 months) and 5-year follow-up was available for 12 patients. Eight-seven percent of the patients achieved a PSA nadir < 0.4 ng/ml. Five-year actuarial biochemical survivals was 64.4 ± 6.0% and 44.6 ± 8.0% for the ASTRO and Phoenix definitions, respectively. A total of 47 underwent posttreatment biopsy. Of these, 12 showed evidence of disease resulting in a positive biopsy rate for those who underwent biopsy of 25.5%. This yields a positive biopsy rate of the entire population of 15.6% (12/77). Conclusions: Cryoablation, as a primary treatment for high-grade Gleason prostate cancer practiced over a wide spectrum of users provides definable biochemical and local control for a hard to manage patient population with aggressive disease

Development of a Nationally Representative Coordinated Registry Network for Prostate Ablation Technologies

The accumulation of data through a prospective, multicenter coordinated registry network is a practical way to gather real world evidence on the performance of novel prostate ablation technologies. Urological oncologists, targeted biopsy experts, industry representatives and representatives of the FDA (Food and Drug Administration) convened to discuss the role, feasibility and important data elements of a coordinated registry network to assess new and existing prostate ablation technologies. A multiround Delphi consensus approach was performed which included the opinion of 15 expert urologists, representatives of the FDA and leadership from high intensity focused ultrasound device manufacturers. Stakeholders provided input in 3 consecutive rounds with conference calls following each round to obtain consensus on remaining items. Participants agreed that these elements initially developed for high intensity focused ultrasound are compatible with other prostate ablation technologies. Coordinated registry network elements were reviewed and supplemented with data elements from the FDA common study metrics. The working group reached consensus on capturing specific patient demographics, treatment details, oncologic outcomes, functional outcomes and complications. Validated health related quality of life questionnaires were selected to capture patient reported outcomes, including the IIEF-5 (International Index of Erectile Function-5), the I-PSS (International Prostate Symptom Score), the EPIC-26 (Expanded Prostate Cancer Index Composite-26) and the MSHQ-EjD (Male Sexual Health Questionnaire for Ejaculatory Dysfunction). Group consensus was to obtain followup multiparametric magnetic resonance imaging and prostate biopsy approximately 12 months after ablation with additional imaging or biopsy performed as clinically indicated. A national prostate ablation coordinated registry network brings forth vital practice pattern and outcomes data for this emerging treatment paradigm in the United States. Our multiple stakeholder consensus identifies critical elements to evaluate new and existing energy modalities and devices