Adenocarcinoma of the ProstateNCT01795365
Active Surveillance of 2 Groups of Patients With Localized Prostate Cancer
A study testing Active surveillance in people with Adenocarcinoma of the Prostate, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Adenocarcinoma of the Prostate
- What is being tested?
- Active surveillance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2012to 26 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- Previous treatment for prostate cancer (including hormonal therapy, radiation therapy, surgery or chemotherapy)
- Patients with hypogonadism
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne
About this study
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.
Read the 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 -)
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
- Conditions
- Adenocarcinoma of the Prostate
- Being tested
- Active surveillance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active surveillanceOther
| Study group | Role | What they receive |
|---|---|---|
| Epstein + (group I) | Active comparator | Epstein + (Group I) PSA <10 ng/ml; Gleason 3+3=6; Number of positive biopsies ≤3/12;
% of tumor biopsy invasion <50% or ≤3mm; mp MRI negative; c-rTNM T1-T2a N0 M0 Receives: Other: Active surveillance |
| Epstein - (group II) | Experimental | Epstein - (Group II) PSA <15 ng/ml; Gleason score max 3+4; Number of positive biopsies ≤5/12
% of tumor biopsy invasion <50% and ≤8mm; mp MRI positive; T1-T2c N0 M0 Receives: Other: Active surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients on active surveillance in group Epstein + and Epstein -
Measured: 6 years
Secondary outcomes (6)
Tumor volume increased, extra-capsular extension or presence of adenopathy assessed on DW-MRI
Measured: baseline, 12, 24, 48 months and every two years.
BCAR-1 test on biopsies
Measured: baseline, 12, 24 months and every 4 years
Percentage of patients who discontinued active surveillance by categories (patient's will, clinical or histological criterion)
Measured: Every 6 months for 6 years
Percentage of deceased patients 10, 15 and 20 years from the inclusion in the study in both groups
Measured: 10, 15, 20 years
Percentage of patients who progressed to a metastatic stage at different time points in both groups
Measured: Every year for 6 years
Quality of life assessment
IPSS score/IIEF-5 score( QLQ-C30 + PR25)
Measured: Every 6 months for 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2013 (estimated)
- Study startDec 2012
- Primary completionJul 2018
- Study completion26 Jul 2018
Why it stopped: Participants are no longer being examined and receiving intervention.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the ProstateStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Patrice Jichlinski, Centre Hospitalier Universitaire Vaudois
- Investigators
- Patrice Jichlinski, MD, Principal investigator, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01795365
- Sponsor's protocol ID
- CHUV Active surveillance
- Status last verified
- Sep 2018
- First submitted
- 23 Jan 2013
- Last updated
- 28 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Surveillance of 2 Groups of Patients With Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT01795365
- Acronym / sponsor ID
- CHUV Active surveillance
- Conditions
- Adenocarcinoma of the Prostate
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Participants are no longer being examined and receiving intervention.
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jul 2018 (actual)
- Study completion
- 26 Jul 2018 (actual)
- First posted
- 20 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 -)
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epstein + (group I) | Active comparator | Other: Active surveillanceEpstein + (Group I) PSA <10 ng/ml; Gleason 3+3=6; Number of positive biopsies ≤3/12; % of tumor biopsy invasion <50% or ≤3mm; mp MRI negative; c-rTNM T1-T2a N0 M0 |
| Epstein - (group II) | Experimental | Other: Active surveillanceEpstein - (Group II) PSA <15 ng/ml; Gleason score max 3+4; Number of positive biopsies ≤5/12 % of tumor biopsy invasion <50% and ≤8mm; mp MRI positive; T1-T2c N0 M0 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (2 listed)
- Previous treatment for prostate cancer (including hormonal therapy, radiation therapy, surgery or chemotherapy)
- Patients with hypogonadism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active surveillance | Other | Epstein + (group I), Epstein - (group II) |
Primary outcome
Proportion of patients on active surveillance in group Epstein + and Epstein -
Time frame: 6 years
6 secondary outcomes
Tumor volume increased, extra-capsular extension or presence of adenopathy assessed on DW-MRI
Time frame: baseline, 12, 24, 48 months and every two years.
BCAR-1 test on biopsies
Time frame: baseline, 12, 24 months and every 4 years
Percentage of patients who discontinued active surveillance by categories (patient's will, clinical or histological criterion)
Time frame: Every 6 months for 6 years
Percentage of deceased patients 10, 15 and 20 years from the inclusion in the study in both groups
Time frame: 10, 15, 20 years
Percentage of patients who progressed to a metastatic stage at different time points in both groups
Time frame: Every year for 6 years
Quality of life assessment
Time frame: Every 6 months for 6 years
Results and safety
The study was stopped early (reason given: Participants are no longer being examined and receiving intervention.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrice Jichlinski, MD principal investigator
Centre Hospitalier Universitaire Vaudois
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active surveillance in people with Adenocarcinoma of the Prostate, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Participants are no longer being examined and receiving intervention.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients on active surveillance in group Epstein + and Epstein - (time frame: 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2018.