Active Control of Prostatic Cancer With Criteria of Latence

Prostate Cancer Clinical Trial

— SURACAP  

Official title:

Active Control of Prostatic Cancer With Criteria of Latence. Impact on Specific 10 Years Survival.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00921258
• Other study ID #: 0700043
• Secondary ID: 2007-A00871-52
• Status: Terminated
• Phase: N/A
• First received: June 12, 2009
• Last updated: June 3, 2015
• Start date: December 2007
• Est. completion date: December 2013

Study information

• Verified date: June 2015
• Source: Clinique Mutualiste Chirurgicale de la Loire
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la Santé
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 74 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	R Azzouzi	Angers
France	Jean-Louis DAVIN	Avignon
France	Henri BENSADOUN	Caen
France	SALOMON	Creteil
France	René GASCHIGNARD	La Roche Sur Yon
France	RUFFION	Lyon
France	Eric LECHEVALLIER	Marseille
France	P. ROSSI	Marseille
France	Xavier REBILLARD	Montpellier
France	RIGAUD Jérôme	Nantes
France	Christophe AVANCES	NiMES
France	IRANI Jacques	Poitiers
France	P Colloby	Pontoise
France	Clinique Mutualiste Chirurgicale	Saint-etienne
France	SOULIE Michel	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Clinique Mutualiste Chirurgicale de la Loire

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluates specific survival to 10 years		10 years	No
Secondary	To evaluate acceptation of 2nd biopsy to confirm latent cancer		10 years	No
Secondary	To evaluate global survival of patient in control		10 years	No
Secondary	To evaluate the survival of patient with a secondary active treatment after a control period		10 years	Yes
Secondary	To evaluate delay to secondary treatment after a period control		10 years	Yes
Secondary	To evaluate survival rate without biological or clinical progression of cancer		10 years	Yes
Secondary	To evaluate quality of life		10 years	No