Active Surveillance for Prostate Cancer With Indolent Features

NCT00421265 | Unknown

• 1 other identifier: 138/06
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

prostate cancer; active surveillance; indolent features

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Gleason's score of 6 or less.
• Clinical T1C per digital rectal exam.
• Pre biopsy PSA serum level of 6.0ng/ml or less.
• The presence of cancer in a single biopsy core of at least 8 taken.
• The presence of cancer in no more than 10% of the length of the core involved.
• 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.
• Israeli residence with the readiness to be available for the followup schedule.

You may not qualify if:

• Patients who do not meet the above eligibility criteria

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

Assaf Harofeh Medical Center

Ẕerifin, 70300, Israel

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Dan Leibovici, M.D.

  Assaf-Harofeh Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dan Leibovici, M.D.

CONTACT

+972-57-346-268; leibovicid@asaf.health.gov.il

Amnon Zisman, M.D.

CONTACT

zismana@asaf.health.gov.il

Study Design

• Study Type: observational
• Observational Model: DEFINED POPULATION
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: January 10, 2007
• First Posted: January 11, 2007
• Last Updated: January 11, 2007

Record last verified: 2007-01

Locations

IL (1)