Laparoscopic Prostate Removal
for Severe, Treatment-Resistant
Chronic Prostatitis


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Research: A clinical trial of laparoscopic radical prostatectomy for severe chronic prostatitis.

To better quantify the association of laparoscopic prostatectomy with relief of chronic prostatitis symptoms, we are conducting a prospective, self-report study of patients who agree to participate. You do not need to be in the study to have treatment. However, our goal is to collect data from our patients and analyze them so that future generations of prostatitis patients will be able to make decisions that are better informed by data than today’s generation. For this reason, we encourage you to participate.

Study participation imposes no additional risk to you and asks simply that 1) in the months after surgery you periocally re-take the symptom questionnaire that you completed before surgery and 2) allow us to pool your answers with those of other men for the purpose of scientific analysis.

The study we are conducting is a prospective, longitudinal, non-randomized, one-arm Phase II study of prostatitis symptoms before and after laparoscopic prostatectomy, a standardized and well described procedure. The symptoms will be measured with the NIH Chronic Prostatitis Symptom Index (CPSI). There are no investigational drugs, devices, or procedures in this trial. This study will be conducted in accordance with this protocol, good clinical practice guidelines, and regulatory requirements. This protocol has been approved by the Western Institutional Review Board, 3535 Seventh Avenue, SW, Olympia, WA 98502-2029. Participation in the study requires completion of this Consent Form.

Study Objectives
The primary trial objective is to describe and quantify the change in prostatitis symptoms in the first six months after laparoscopic prostatectomy. It is secondarily to identify socio-demographic and/or medical markers of response.

Study Endpoints
NIH-CPSI scores at one month, three months, and six months after laparoscopic prostatectomy.

Study Duration
As part of the study each subject will be observed for six months after laparoscopic prostatectomy. Separately, as a patient of the principal investigator each subject will be observed for as long as medical care requires.

Study Discontinuation
This is a questionnaire trial conducted after a single episode of surgery. There are no reasons to discontinue subjects and ask them to stop completing questionnaires (subjects are permitted to discontinue themselves).

Study Recruitment
Subjects will be recruited using a doctor-to-doctor recruitment letter and this web site; other recruits may come also from the
National Institutes of Health clinical trials registry.
The letter will be mailed and emailed to the PI’s professional contacts and to urologists.

Inclusion Criteria
Potential subjects will be screened and enrolled if they meet the following criteria:

Age 30 years or greater
NIH-CPSI score of 25 or higher
Symptom duration of at least one year
Failed treatment with antibiotics and/or other medications

Exclusion Criteria
Inability to tolerate anesthesia
Inability to speak English

Medical Care
Enrolled candidates will have laparoscopic prostatectomy as described above. Usual patterns of care will apply to pre-operative preparation, laparoscopic prostatectomy, and post-operative care. For example, patients will be given pre-operative preparation instructions: no aspirin, nothing to eat after midnight, and the like. Each study subject will be a patient of the Principal Investigator and as such will be cared for as would any patient.

Study Follow-up
Patients will complete the NIH-CPSI one month, three months, and six months after surgery.

Data Analysis
Data will be stripped of identifiers before analysis by Shenghan Lai, MD PhD, Professor of Epidemiology, Medicine, Radiology, and Pathology at Johns Hopkins Medical Institute; Dr. Lai is leader of the Biostatistics Core of the Reynolds Cardiovascular Research Center and the biostatistics reviewer for Circulation. He will apply such various analytical tests as he deems necessary.

Direct Access
The sponsor will permit trial-related monitoring, audits, IRB review, and regulatory inspection by providing direct access to source data and documents.

Ethical considerations
Men with chronic prostatitis are often desperate to find relief. This is partly manifested in their willingness to travel across the world for various treatments ranging from massage to intra-prostatic injections to herbal and dietary manipulations. In their desperation they are vulnerable to the manipulations of the unscrupulous practitioner. As such, they depend for their welfare on the objective and thoughtful representation of any proposed treatment. This falls to the practitioner, in this case the principal investigator. Most to the point, it is ethically incumbent upon the principal investigator to fairly represent that there is essentially no scientific support for the notion that laparoscopic prostatectomy is a durable and effective remedy for the symptoms of chronic prostatitis. The most that is currently available is a handful of cases from which we infer that such support might be forthcoming (and for which reason we are conducting this trial). These points are spelled out in the informed consent and will be repeated to each applicant.

When support of a proposed treatment is merely a handful of cases the first rule of medicine – first do not harm – seems especially relevant. For this reason and to minimize risk, it is likewise imperative that the treatment be delivered by the most experienced practitioner. In this case each laparoscopic prostatectomy will be performed by the principal investigator, a pioneer of it and who runs a practice focused exclusively on it.

The Krongrad Institute will finance personnel involved in questionnaire administration and data collection, management, and analysis. The laparoscopic prostatectomy will be financed by study subjects and or their medical insurance carriers.

The observed analyses will be submitted for publication.

Statistical Analysis
The study statistician is Shenghan Lai, MD PhD, Professor of Epidemiology, Medicine, Pathology, and Radiology at Johns Hopkins School of Medicine. Dr. Lai has published extensively with Dr. Krongrad.

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