Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-01-02 @ 11:44 AM
Study NCT ID:
NCT00921258
Status:
TERMINATED
Last Update Posted:
2015-06-04
First Post:
2009-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Active Control of Prostatic Cancer With Criteria of Latence
Sponsor:
Clinique Mutualiste Chirurgicale de la Loire
Organization:
Study Overview
Official Title:
Active Control of Prostatic Cancer With Criteria of Latence. Impact on Specific 10 Years Survival.
Status:
TERMINATED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Financial problem (not enough budget to continue the study)
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SURACAP
Brief 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.
* 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.
Detailed Description:
This study concern the active control during 10 years of patient with latent prostate cancer who accept not be treated immediately.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2007-A00871-52 | None | None | View |