Active Surveillance for Prostate Cancer With Indolent Features

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00421265
Recruitment Status : Unknown
Verified January 2007 by Assaf-Harofeh Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : January 11, 2007
Last Update Posted : January 11, 2007
Information provided by:
Assaf-Harofeh Medical Center

Brief 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.

Condition or disease
Prostate Cancer

Study Type : Observational
Enrollment : 150 participants
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Prospective Cohort Study of Active Surveillance for Prostate Cancer With Indolent Linical Features

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00421265

Contact: Dan Leibovici, M.D. +972-57-346-268
Contact: Amnon Zisman, M.D.

Assaf Harofeh Medical Center Not yet recruiting
Zerifin, Israel, 70300
Contact: Dan Leibovici, M.D.    +972-57-7346-268   
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Principal Investigator: Dan Leibovici, M.D. Assaf-Harofeh Medical Center Identifier: NCT00421265     History of Changes
Other Study ID Numbers: 138/06
First Posted: January 11, 2007    Key Record Dates
Last Update Posted: January 11, 2007
Last Verified: January 2007

Keywords provided by Assaf-Harofeh Medical Center:
prostate cancer
active surveillance
indolent features

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases