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N/A
18 Years
75 Years
Open (Enrolling)
Male
Adenocarcinoma of the Prostate

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Trial Information


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 patients quality of life

- 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 metastatic disease

- To evaluate the time to radical treatment


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% with a number of positive tumor biopsies <3
(group I patients) or ≤ 4 (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 <0.5 ml (group I patients); <1 ml (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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of patients on active surveillance in group Epstein + and Epstein -

Outcome Time Frame:

6 years

Safety Issue:

Yes

Principal Investigator

Patrice Jichlinski, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Hospitalier Universitaire Vaudois

Authority:

Switzerland: Ethikkommission

Study ID:

CHUV Active surveillance

NCT ID:

NCT01795365

Start Date:

December 2012

Completion Date:

October 2017

Related Keywords:

  • Adenocarcinoma of the Prostate
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms

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