Active Surveillance of 2 Groups of Patients With Localized Prostate Cancer

Adenocarcinoma of the Prostate Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01795365
• Other study ID #: CHUV Active surveillance
• Status: Terminated
• Phase: N/A
• Start date: December 2012
• Est. completion date: July 26, 2018

Study information

• Verified date: September 2018
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 possibility to offer them curative treatment once the tumor seems to progress.

The goal of this study is to validate the treatment option Active Surveillance in men with localized, well differentiated prostate cancer, in order to limit the amount of overtreatment. A number of key points will be studied, such as the pathological findings in radical prostatectomy specimens, and the effect of expectancy on the quality of life.

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 -)

Secondary

• To evaluate the role of diffusion-weighted MRI (DW-MRI) in the initial diagnosis and the follow-up of patients under active surveillance

• To evaluate the role of BCAR-1 to predict the clinical outcome of localized prostate cancer

• To evaluate the proportion of patients who discontinued active surveillance

• To evaluate the mortality at 10, 15 and 20 years from the inclusion in the study

• To evaluate the time to radical treatment

• To evaluate the time to metastatic disease

• To evaluate patients quality of life

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: July 26, 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• Previous treatment for prostate cancer (including hormonal therapy, radiation therapy, surgery or chemotherapy)

• Patients with hypogonadism

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Prostate
• Prostatic Neoplasms

Intervention

Other:
• Active surveillance

Locations

Country	Name	City	State
Switzerland	Centre Hospitalier Universitaire Vaudois (CHUV)	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients on active surveillance in group Epstein + and Epstein -		6 years
Secondary	Tumor volume increased, extra-capsular extension or presence of adenopathy assessed on DW-MRI		baseline, 12, 24, 48 months and every two years.
Secondary	BCAR-1 test on biopsies		baseline, 12, 24 months and every 4 years
Secondary	Percentage of patients who discontinued active surveillance by categories (patient's will, clinical or histological criterion)		Every 6 months for 6 years
Secondary	Percentage of deceased patients 10, 15 and 20 years from the inclusion in the study in both groups		10, 15, 20 years
Secondary	Percentage of patients who progressed to a metastatic stage at different time points in both groups		Every year for 6 years
Secondary	Quality of life assessment	IPSS score/IIEF-5 score( QLQ-C30 + PR25)	Every 6 months for 6 years