Clinical trial · Observational
Active Control of Prostatic Cancer With Criteria of Latence
Active Control of Prostatic Cancer With Criteria of Latence. Impact on Specific 10 Years Survival.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Financial problem (not enough budget to continue the study)
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| prostate biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- control group
- description
- Patient with latent prostate cancer who agree to be controled instead of to be treated
- interventionNames
- Procedure: prostate biopsy
Primary outcomes (1)
- measure
- Evaluates specific survival to 10 years
- timeFrame
- 10 years
Secondary outcomes (6)
- measure
- To evaluate acceptation of 2nd biopsy to confirm latent cancer
- timeFrame
- 10 years
- measure
- To evaluate global survival of patient in control
- timeFrame
- 10 years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 74 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available