Status:
TERMINATED
Active Surveillance of 2 Groups of Patients With Localized Prostate Cancer
Lead Sponsor:
Centre Hospitalier Universitaire Vaudois
Conditions:
Adenocarcinoma of the Prostate
Eligibility:
MALE
18-75 years
Phase:
NA
Brief Summary
Active Surveillance manages selected men with prostate cancer expectantly with curative intent. This means men are carefully selected and subsequently actively observed in order to have the possibilit...
Detailed Description
Objectives: Primary \- To evaluate the equivalence of the time on active surveillance before an active treatment between group Epstein + and the expanded active surveillance group (Epstein -) Secon...
Eligibility Criteria
Inclusion
- Localized adenocarcinoma of the prostate with a Gleason score of 3+3 (group I patients) or 3+4 (group II patients)
- Percentage of tumor biopsy invasion \<50% and/or with a size of maximum 8 mm
- With a number of positive tumor biopsies ≤3 (group I patients) or ≤ 5 (group II patients)
- TNM stage T1-2a N0 M0 (group I patients); TNM stage T1-2c N0 M0 (group II patients)
- PSA level at diagnosis \< 10 ng/ml for group I patients; \< 15 ng/ml for group II patients
- Tumor volume negative (group I patients); positive (group II patients)
- Absence of extra-capsular extension
- Life expectancy \> 10 years
- Signed informed consent
- Patient has elected active surveillance as preferred management plan for the prostate cancer
Exclusion
- Previous treatment for prostate cancer (including hormonal therapy, radiation therapy, surgery or chemotherapy)
- Patients with hypogonadism
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 26 2018
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01795365
Start Date
December 1 2012
End Date
July 26 2018
Last Update
September 28 2018
Active Locations (1)
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1
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Switzerland