Clinical trial · Observational
Active Surveillance for Low Risk Prostate Cancer
Active Surveillance Methodology for Low Risk Prostate Cancer
NCT04146077CI-TRIAL-00052839recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
An active surveillance protocol for patients diagnosed low-risk prostate cancer will be held. We plan to use PSA (prostate-specific antigen) testing, DRE (digital rectal examination), TRUS (transrectal ultrasound), MRI (magnetic resonance imaging) and follow-up biopsies to monitor patients and detect cancer progression in time.
Conditions
Conditions (2)
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 Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- cancer progression
- timeFrame
- 5 years
- description
- Number of patients who had one of the following signs of cancer progression: new lesion on DRE proved by biopsy, or histological upgrade on follow-up biopsy, or involvement of more than 33% cores on follow-up biopsy
Secondary outcomes (1)
- measure
- surgical treatment due to infravesical obstruction by BPH
- timeFrame
- 5 years
- description
- Number of patients who underwent any treatment due to BPH: endoscopic procedures, or simple prostatectomy, or punction cystostomy
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * prostate adenocarcinoma verified by at least 12 core biopsy * patient must understand the sense of research, agree to participate and sign a form of agreement * low oncological risk according to EAU (European Association of Urology) Guidelines: stage T1-T2a, PSA\<10 ng/ml, ISUP (International Society of Urological Pathologists score)=1 (Gleason score 3+3=6) * not more than 33% cores with adenocarcinoma Exclusion Criteria: * previous treatment of prostate cancer * other prostatic malignant neoplasms * other oncological diseases * treatment with 5-alfa-reductase inhibitors * patient's refuse to continue study * patient's desire to begin treatment
References
Publications (0)
Data not yet available
No reference posted for this study.