Active Surveillance for Prostate Cancer With Indolent Features

Prostate Cancer Clinical Trial

Official title:

Prospective Cohort Study of Active Surveillance for Prostate Cancer With Indolent Linical Features

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00421265
• Other study ID #: 138/06
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: January 10, 2007
• Last updated: January 10, 2007

Study information

• Verified date: January 2007
• Source: Assaf-Harofeh Medical Center
• Contact: Dan Leibovici, M.D.
• Phone: +972-57-346-268
• Email: leibovicid[@]asaf.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 65 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
Israel	Assaf Harofeh Medical Center	Zerifin

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel,