Active Surveillance for Prostate Cancer With Indolent Features

Shamir Medical Center (Assaf-Harofeh)

Status: Unknown

Conditions: Prostate Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT00421265

138/06

Details and patient eligibility

About

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.

Sex: Male

Ages: 65 to 80 years old

Volunteers: No Healthy Volunteers

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