4-Kallicreins score study as a predictor of tumor reclassification in a program of active surveillance of prostate cancer.
- Conditions
- Spain male residents diagnosed with low risk CaP (NCCN)Cancer
- Registration Number
- ISRCTN50041002
- Lead Sponsor
- Servicio Urología. Instituto Valenciano de Oncología
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 300
1. PSA = 10 ng / mL; if prostate volume> 60 cc in transrectal, ultrasound included with PSA>10 ng / ml if PSAD <0.20
2. Local Stadium DRE; cT1c -cT2a
3. Diagnosis of transrectal ultrasound guided biopsy minimum 10 cylinders
4. Adenocarcinoma Prostate Gleason = 6 (3 + 3) with local and central pathology review
5. Maximum number of cylinders = 2 and none of them more than 5mm tumor or more than 50% of
assignment
6. <80 years and greater expectancy to 10 years life (Charlson score)
7. Patients able to understand VA and sign the informed consent
8. Possibility for the Hospital Project and associated patient acceptance at inclusion to performance the test of 4Kscore followed by a biopsy confirmation at 6 months diagnostic. This transrectal ultrasound-guided biopsy may be making 18 cylinders or ultrasound-guided transperineal brachytherapy making from 24 to 32 cylinders according with prostate volume. Both possibilities allow extra biopies to confirm suspected areas by ultrasound or RMNmp 1.5T (which is optional)
1. Patient not be able to accept repeat biopsies
2. Patient who does not want to sign the Informed Consent
3. Hospital where the possibility of a biopsy confirmation at 6 months is not guaranteed under the terms of the inclusion criteria
4. If the central pathology review of diagnostic biopsy is estimated not met
inclusion criteria marking the protocol
5. Patients with a history of ASAP (atypical small acinar proliferation or atypical microglándulas)
6. Patients with treatment with inhibitors of 5-alpha-reductase as dutasteride (Avodart®) and finasteride (Proscar®) during the previous six months
7. Patients who have undergone during the 6 months prior to any treatment symptomatic benign prostate hyperplasia, or any invasive urological procedure. It can be associated with an increase of PSA prior to phlebotomy. These therapies include, but they are not limited to, prostate biopsy, thermotherapy, microwave therapy, laser, urethral resection of the prostate, urethral catheterization and the lower genitourinary tract endoscopy
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the value of the 4Kscore test as a predictor of tumor reclassification in an active surveillance program in Prostate Cancer (PCa).<br><br>A sample of whole blood will be collected, six months after diagnostic biopsy, always before digital rectal examination if it is repeated at 6 months and proceed to dispatch in accordance with instructions OPKO Health Spain SL. The result will be stored in a database to analyze the results and sent to the principal investigators after the study. The research partners will include sample code for each patient in the database of PIEM, thus the traceability of the sample is guaranteed and will enable leading researchers characterize their code samples. No type of therapeutic action is permitted until after the biopsy confirmation, since the analysis of the results will be centralized and blinded manner, after confirmation biopsies done.
- Secondary Outcome Measures
Name Time Method 1. Free survival of active treatment: means the time elapsed between the entry into active surveillance with the initial biopsy and the adoption of a active treatment such as prostatectomy, brachytherapy, Radiotherapy Treatment or Focal Ablation Techniques<br>2. Progression-free survival: defined as the time to the pathological tumor progression during follow-up, defining this with the same conditions but detected in tumor reclassification follow-up biopsies. It is also understood as progression if the researcher associated defines the presence of local or regional progression by physical or radiological examinations