Active Surveillance for Prostate Cancer With Indolent Features

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by Assaf-Harofeh Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT00421265
First received: January 10, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
  Purpose

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 Phase
Prostate Cancer
Phase 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Assaf-Harofeh Medical Center:

Estimated Enrollment: 150
  Eligibility

Ages Eligible for Study:   65 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00421265

Contacts
Contact: Dan Leibovici, M.D. +972-57-346-268 leibovicid@asaf.health.gov.il
Contact: Amnon Zisman, M.D. zismana@asaf.health.gov.il

Locations
Israel
Assaf Harofeh Medical Center Not yet recruiting
Zerifin, Israel, 70300
Contact: Dan Leibovici, M.D.    +972-57-7346-268    leibovicid@asaf.health.gov.il   
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Principal Investigator: Dan Leibovici, M.D. Assaf-Harofeh Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00421265     History of Changes
Other Study ID Numbers: 138/06
Study First Received: January 10, 2007
Last Updated: January 10, 2007
Health Authority: Israel: Ministry of Health

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
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 31, 2014