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Active Surveillance for Prostate Cancer With Indolent Features

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00421265
Enrollment
150
Registered
2007-01-11
Start date
Unknown
Completion date
Unknown
Last updated
2007-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

prostate cancer, active surveillance, indolent features

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.

Interventions

None listed

Sponsors

Assaf-Harofeh Medical Center
Lead SponsorOTHER_GOV

Study design

Observational model
DEFINED_POPULATION
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
65 Years to 80 Years
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

Countries

Israel

Contacts

Primary ContactDan Leibovici, M.D.
leibovicid@asaf.health.gov.il+972-57-346-268
Backup ContactAmnon Zisman, M.D.
zismana@asaf.health.gov.il

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026