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TerminatedNCT00921258SURACAPUpdated Jun 4, 2015

Active Control of Prostatic Cancer With Criteria of Latence

An observational study in Prostate Cancer, sponsored by Clinique Mutualiste Chirurgicale de la Loire. Terminated at 15 sites in France. Open to male participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2015-06-04.

Sponsored by Clinique Mutualiste Chirurgicale de la Loire · Observational

Why this study was terminated
Financial problem (not enough budget to continue the study)
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 74 Years
Sex
Male
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 509 studies in Prostatic Neoplasms with a site in France — 92 open to participants now, 156 under way, 50 of them phase 3. Prostatic Neoplasms · France.

Enrollment
65th of 99
100 · median 183
Started
2007
with 7 others
Observational
99 of 509
21 open now
Registered
67th of 509
by date

Among the 509 studies in Prostatic Neoplasms with a site in France, this one is the 65th largest by enrollment of the 99 observational ones that give a count, is one of 8 that started in 2007, is one of 99 observational ones, and was the 67th registered.

Prostatic Neoplasms

7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.

Browse Prostatic Neoplasms studies →

Open to participants now

92 of the 509 studies in Prostatic Neoplasms with a site in France are open now. Recruiting first, the newest first:

87 more — sign in →

All 92 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 1,228 Prostatic Neoplasms studies recruiting now, 928 (76%) set no upper age limit and 76 (6%) stop at 75 or younger; 67 take children under 18; 82 take healthy volunteers.

This study: 18 Years to 74 Years · male · no healthy volunteers.

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02

Study summary

This study concern a prospective cohort pf patients with latent prostate cancer. We study the specific survival at 10 years of patients who accept an active control.Patients inclusion are realized in 2 stages:

  • patient with inclusion criteria (PSA \< 10 ng/ml, clinical stage T1c or T2a, Gleason \< or = 6) are registered if they accept a second prostate biopsy in a 3 months delay
  • after analyse of second biopsy in central laboratory and confirmation of latent prostate biopsy, patients are included if they accept active control Included patients will have 1 biopsy by years the first two years and then 1 biopsy each 2 years during 8 years.

If progression of cancer happens during the 10 years control, active control will be stopped and patient will be treated by surgery and chemotherapy.

Read the detailed description

This study concern the active control during 10 years of patient with latent prostate cancer who accept not be treated immediately.

03

Conditions studied

  • Prostate Cancer

Browse trials for

Keywords

  • latent prostate cancer
  • Patient with latent prostate cancer
  • PSA ≤ 10 ng/ml
  • Clinical stage T1c or T2a
  • Patient who accept just be control
04

Who can participate

Ages eligible
18 Years to 74 Years
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients with latent prostate cancer who agree to be controlled instead of to be immediately treated for this cancer

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patient with a latent prostatic cancer
  • aged less 75 years old,
  • life expectation higher than 10 years
  • Clinic statue T1c or T2a
  • with a seric PSA (prostatic specific antigen)smaller than 10ng/ml
  • more than 10 cores samples
  • patient with less than 3 cores samples with tumor and none care sample with more than 3mm of tumor
  • Gleason score inferior at 7
  • patient's agreement about project and a second biopsy which will include definitive patient: realized 3 months after the first and having: 14 biopsy cores samples (10 like previously and 4 more specific: taking around the positives initials biopsies), less than 3 cores samples with tumor, ,any cores samples with more than 3mm of tumor, a Gleason score superior at 7.

Exclusion criteria

Exclusion Criteria:

  • patient aged 75 years old and more
  • no patient's agreement
  • lack of understanding of plan
  • patient with guardianship
  • life expectation smaller than 10 years
  • patient with an other cancer less than 5 years
  • Local clinical statue greater than T2a
  • seric PSA higher than 10ng/ml
  • less than 10
  • more than 2 positives biopsies during the first intervention
  • 3 cores samples with more than 3mm of tumor
  • 4th grade on the biopsies
  • patient's refuse to realize the second biopsies
  • patient who ask a treatment after the first medical examination
  • patient with less 4 special biopsies around the previously initial cores samples or more than 2 positives biopsies or biopsies with more than 3mm of tumor or patient having a 4 grade on biopsies, during the second medical examination.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)

Groups and cohorts

  • control group

    Patient with latent prostate cancer who agree to be controled instead of to be treated

    Procedure: prostate biopsy

Interventions

  • Procedureprostate biopsy

    patient of control group will have : * 1 prostate biopsy 3 months after diagnostic biopsy * 1 prostate biopsy each year during 2 years * 1 prostate biopsy each 2 years during 8 years

06

What researchers measure

Primary outcomes

  1. Evaluates specific survival to 10 years

    Time frame: 10 years

Secondary outcomes

  1. To evaluate acceptation of 2nd biopsy to confirm latent cancer

    Time frame: 10 years

  2. To evaluate global survival of patient in control

    Time frame: 10 years

  3. To evaluate the survival of patient with a secondary active treatment after a control period

    Time frame: 10 years

  4. To evaluate delay to secondary treatment after a period control

    Time frame: 10 years

  5. To evaluate survival rate without biological or clinical progression of cancer

    Time frame: 10 years

  6. To evaluate quality of life

    Time frame: 10 years

07

Study locations

15 sites
  • R Azzouzi
    Angers, France
  • Jean-Louis DAVIN
    Avignon, France
  • Henri BENSADOUN
    Caen, 14000, France
  • SALOMON
    Creteil, France
  • René GASCHIGNARD
    La Roche Sur Yon, 85000, France
  • RUFFION
    Lyon, 69000, France
  • Eric LECHEVALLIER
    Marseille, 13 385, France
  • P. ROSSI
    Marseille, 13000, France
  • Xavier REBILLARD
    Montpellier, France
  • RIGAUD Jérôme
    Nantes, France
  • Christophe AVANCES
    NiMES, France
  • IRANI Jacques
    Poitiers, 86000, France
  • P Colloby
    Pontoise, France
  • Clinique Mutualiste Chirurgicale
    Saint-etienne, 42055, France
  • SOULIE Michel
    Toulouse, 31059, France
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2007, a primary completion of Dec 2013 and a completion of Dec 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 12, 2009
First posted
Jun 16, 2009
Start
Dec 2007
Primary completionActual
Dec 2013
CompletionActual
Dec 2013
Last update
Jun 4, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 4, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00921258
Lead sponsor
Clinique Mutualiste Chirurgicale de la Loire
Responsible party
Sponsor
First posted
Jun 16, 2009
Start date
Dec 2007
Primary completion
Dec 2013
Completion
Dec 2013
Last update
Jun 4, 2015

Study contacts

Nicolas MOTTET, Dr
principal investigator · Clinique Mutualiste Chirurgicale

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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