Clinical Trials

EDAP Ablatherm ® Integrated Imaging High Intensity Focused Ultrasound (HIFU) indicated for treatment of low risk, localized prostate cancer (CaP)

The purpose of this clinical trial is to compare the results of HIFU with prostate cryotherapy (the current standard of care). If HIFU is approved by the FDA to treat low-risk CaP, men would have an additional minimally invasive option to consider.

The clinical trial includes both investigational and control groups. Our site is a control group, which means participants in the research study will receive the standard treatment (cryotherapy).  Drs. Rukstalis and Danella are the investigators involved in this research study. Study procedures will be covered by most insurance policies since cryotherapy is a standard of care treatment.

You may be eligible to participate in the clinical research study if you are:

• 60 years of age or older
• Clinical stage T1a, b, or c, or T2a
• Gleason 6 or less  CaP confirmed by PSA and TRUS biopsy (in past 6 mo)

Interested individuals should call the Urology department (570) 271-6328 for more information or let your Urologist know that you are interested in being in the study.

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Geisinger's urology department is beginning a clinical trial entitled EDAP Ablatherm ® Integrated Imaging High Intensity Focused Ultrasound (HIFU) indicated for treatment of low risk, localized prostate cancer.

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studies 

Long-Term Results Of Cryoablation For Renal Cancer And Complex Renal Masses
UroToday.com
Davol PE, Fulmer BR, Rukstalis DB Urology. 2006 Jul; 68(supp 1A):2-6

In situ thermal destruction of renal masses through the creation of lethal cold temperatures has become an acceptable treatment option for patients with incidentally discovered small renal lesions. Few long-term studies have been published to examine the efficacy and safety of the procedure.

In a recent review, P. E. Davol, D. Rukstalis and colleagues from Geisinger Health System in Danville, Pennsylvania, the long-term results of cryosurgical ablation of renal neoplasms is reported. The report is published in the July 2006 issue of Urology. A retrospective review of a cohort of 48 patients treated with either open (n = 24) or laparoscopic (n = 24) cryoablation of worrisome renal masses who had at least 36 months of follow-up (median 64 months) was completed.

Patient demographics, tumor characteristics, radiologic follow-up and disease-free and overall survival data were evaluated. Follow-up imaging was by MRI very frequently initially but has evolved to one post-op MRI at 3-months post-op and then every 6 months thereafter. Radiographic success was defined as an involuted scar or fibrosis without evidence of growth or enhancement on the most recently available imaging study.

Analysis of the results showed a mean age of the cohort to be 62 years. The mean size of the renal mass was 2.6 cm. Forty-four lesions were exophytic, 4 were central, 38 masses were solid, and 11 were cystic but suspicious. A total of 12.5% of patients were diagnosed with persistent disease during the follow-up period. The failures were treated with either laparoscopic nephrectomy (n = 2), laparoscopic partial nephrectomy (n = 1), repeat cryoablation (n = 1) and one elected observation. This patient experienced distant lung metastasis after 60 months of follow-up. Overall cancer specific survival was 100% and the cancer-free survival rate after a single cryoablation procedure was 87.5%. This improved to 97.5% after a repeat procedure. No major complications were observed.  This data suggests that cryosurgical ablation of renal neoplasms can lead to acceptable long-term disease free survival.

Careful radiologic follow-up strategies are crucial in monitoring treatment success and identifying those who may require a secondary salvage procedure.

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 SAFETY AND EFFICACY OF EXISULIND FOR TREATMENT OF RECURRENT PROSTATE CANCER AFTER RADICAL PROSTATECTOMY.
Journal of Urology. 166(3):882-886, September 2001.
GOLUBOFF, ERIK T. * +; PRAGER, DIANE +; RUKSTALIS, DANIEL +; GIANTONIO, BRUCE; MADORSKY, MARTIN; BARKEN, ISRAEL; WEINSTEIN, I. BERNARD +; PARTIN, ALAN W. +; OLSSON, CARL A. + ++; THE UCLA ONCOLOGY RESEARCH NETWORK [S]
Abstract:
Purpose: We evaluated the safety and efficacy of exisulind for delaying disease progression in men with increasing prostate specific antigen (PSA) after radical prostatectomy.

Materials and Methods: A total of 96 men with increasing PSA after radical prostatectomy were randomized to receive placebo (49) or 250 mg. exisulind twice daily (47) for 12 months. The primary efficacy parameter was the difference in change from baseline PSA between the placebo and exisulind groups. The PSA doubling time was also evaluated before and during study. A subgroup analysis classified patients based on the risk of developing metastatic disease.

Results: Compared with placebo, exisulind significantly suppressed the increase in PSA in all patients (p = 0.017). The results were also statistically significant in men at high risk for metastasis (p = 0.0003) and those who could not be classified according to risk (p = 0.0009). In addition, median PSA doubling time was lengthened in high risk patients on exisulind (2.12 month increase) compared with those on placebo (3.37 month decrease, p = 0.048). Exisulind was well tolerated.

Conclusions: Exisulind inhibited the increase in PSA overall and prolonged PSA doubling time in high risk patients compared with placebo. These results suggest that Exisulind has the potential to extend the time from biochemical recurrence to the need for androgen deprivation therapy. Exisulind was well tolerated in this patient population. Our results support further study of Exisulind in the treatment of patients with prostate cancer.

Copyright (C) 2001 by American Urological Association, Inc.

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 PROSTATE CRYOABLATION: A SCIENTIFIC RATIONALE FOR FUTURE MODIFICATIONS
Rukstalis DB, Goldknopf JL, Crowley EM, Garcia FU.

Department of Surgery, Division of Urology, MCP Hahnemann University School of Medicine, Philadelphia, Pennsylvania 19129, USA.

Abstract:
This investigation was designed to identify potential directions for future modification of the percutaneous prostate cryoablation procedure. An analysis of prostate cancer location and volume in radical prostatectomy specimens was performed to evaluate the potential clinical consequences of these proposed modifications. A list of recommendations for improvements in the prostate cryoablation procedure was compiled from informal discussions held with participants in 9 training courses and conferences on prostate cryoablation over 18 months. Subsequently, a population of 112 consecutive, sagittally sectioned whole-mount radical prostatectomy samples was evaluated for prostate cancer volume, number of individual foci, and location to examine the disease-specific outcomes of these proposed modifications. The most common areas for potential alterations in the current cryoablation technique include modifications that would further simplify the procedure, continue to reduce real and perceived toxicity, and augment efficacy. Importantly, modifications designed to reduce treatment side effects could conflict with efforts designed to improve eradication of prostate cancer. Pathologic analysis revealed multifocal cancer in 79.5% of the samples, with 66% of cases exhibiting cancer within 5 mm of the urethra. The median volume of the index cancer was 1.6 cm3, whereas the median volume of the smaller ancillary lesions was 0.3 cm3. Prostate parenchymal-sparing alterations, proposed to reduce incontinence and erectile dysfunction by targeting the index cancer, would likely eradicate clinically significant cancer in 79% of men. The recent enthusiasm for prostate cryoablation as a reasonable minimally invasive treatment option for men with clinically localized cancer is likely to result in modifications of the established surgical technique. Knowledge of the anatomic location and cancer volume within the prostate gland is an important adjunct to planning such alterations. It is possible that parenchymal-sparing modifications to total gland prostate cryoablation can eradicate clinically significant cancer in most men, with a reduction in toxicity and cost.

PMID: 12206844 [PubMed - indexed for MEDLINE]

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