Active Control of Prostatic Cancer With Criteria of Latence (SURACAP)

This study has been completed.
Sponsor:
Information provided by:
Clinique Mutualiste Chirurgicale de la Loire
ClinicalTrials.gov Identifier:
NCT00921258
First received: June 12, 2009
Last updated: July 20, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Prostate Cancer
Procedure: prostate biopsy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Active Control of Prostatic Cancer With Criteria of Latence. Impact on Specific 10 Years Survival.

Resource links provided by NLM:


Further study details as provided by Clinique Mutualiste Chirurgicale de la Loire:

Primary Outcome Measures:
  • Evaluates specific survival to 10 years [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate acceptation of 2nd biopsy to confirm latent cancer [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • To evaluate global survival of patient in control [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • To evaluate the survival of patient with a secondary active treatment after a control period [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • To evaluate delay to secondary treatment after a period control [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • To evaluate survival rate without biological or clinical progression of cancer [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • To evaluate quality of life [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: December 2007
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
control group
Patient with latent prostate cancer who agree to be controled instead of to be treated
Procedure: prostate 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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 74 Years
Genders Eligible for Study:   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

Criteria

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 biopsy 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:

  • 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 biopsies
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00921258

Locations
France
R Azzouzi
Angers, France
Jean-Louis DAVIN
Avignon, France
Henri BENSADOUN
Caen, France, 14000
SALOMON
Creteil, France
René GASCHIGNARD
La Roche Sur Yon, France, 85000
RUFFION
Lyon, France, 69000
P. ROSSI
Marseille, France, 13000
Eric LECHEVALLIER
Marseille, France, 13 385
Xavier REBILLARD
Montpellier, France
RIGAUD Jérôme
Nantes, France
Christophe AVANCES
NiMES, France
IRANI Jacques
Poitiers, France, 86000
P Colloby
Pontoise, France
Clinique Mutualiste Chirurgicale
Saint-etienne, France, 42055
SOULIE Michel
Toulouse, France, 31059
Sponsors and Collaborators
Clinique Mutualiste Chirurgicale de la Loire
Investigators
Principal Investigator: Nicolas MOTTET, Dr Clinique Mutualiste Chirurgicale
  More Information

No publications provided

Responsible Party: Dr Nicolas MOTTET, Clinique Mutualiste Chirurgicale de la Loire
ClinicalTrials.gov Identifier: NCT00921258     History of Changes
Other Study ID Numbers: 0700043, 2007-A00871-52
Study First Received: June 12, 2009
Last Updated: July 20, 2011
Health Authority: France: Direction Générale de la Santé

Keywords provided by Clinique Mutualiste Chirurgicale de la Loire:
latent prostate cancer
Patient with latent prostate cancer
PSA ≤ 10 ng/ml
Clinical stage T1c or T2a
Patient who accept just be control

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 29, 2014