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Active Surveillance for Prostate Cancer With Indolent Features

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase II, Phase I

Natural history/Epidemiology, Screening

Approved-not yet active

65 to 80

Other

138/06
NCT00421265

Trial Description

Summary

In patients with prostate cancer with indolent features, disease progrssion may be very slow and in many cases will never become clinically evident during the patient's lifetime. Active surveillance is a continuous process of monitoring disease characteristcs aiming to avoid the morbidity of active therapy in patients with stabe indolent parameters, while offering early detection of disease activity in others who will need active therapy to control their disease. We hypothesize that active surveillance will permit the avoidance of therapy related morbidity in the majority of appropriate patients and will be associated with maintaining their quality of life.

Eligibility Criteria

Inclusion Criteria:

1. Men 65 years of age or older who were diagnosed with prostate cancer in the past 3 month prior to inclusion

2. Gleason's score of 6 or less.

3. Clinical T1C per digital rectal exam.

4. Pre biopsy PSA serum level of 6.0ng/ml or less.

5. The presence of cancer in a single biopsy core of at least 8 taken.

6. The presence of cancer in no more than 10% of the length of the core involved.

7. Patient's consent to engage in active surveillance after being informed of the benefits and potential risks of this approach as well as of alternative lines of therapy.

8. Israeli residence with the readiness to be available for the followup schedule.

Exclusion Criteria:

Patients who do not meet the above eligibility criteria

Trial Contact Information

Trial Lead Organizations/Sponsors

Assaf Harofeh Medical Center

Dan Leibovici, M.D.

Principal Investigator

Dan Leibovici, M.D.		Ph: +972-57-346-268
		Email: leibovicid@asaf.health.gov.il

Amnon Zisman, M.D.
		Email: zismana@asaf.health.gov.il

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00421265
Information obtained from ClinicalTrials.gov on October 20, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.