Clinical trial · Observational
Active Surveillance or Radical Treatment for Newly Diagnosed Patients With a Localized, Low Risk, Prostate Cancer START
START (Active Surveillance or Radical Treatment for Newly Diagnosed Patients With a Localized, Low Risk, Prostate Cancer): an Epidemiological Study of the Oncology Network of Piemonte and Valle d'Aosta (Italy)
NCT03348722CI-TRIAL-00065207STARTcompletedClinicalTrials.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)
The purpose of the START project is to evaluate the acceptability, the safety and the cost-effectiveness of a population based program of active surveillance for patients newly diagnosed with a localized, low risk, prostate cancer.
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 |
|---|---|---|---|
| Prostatic Neoplasm | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Active surveillance | Other | — | UNRESOLVED |
| Other radical treatments | Procedure | — | UNRESOLVED |
| Radical prostatectomy | Procedure | — | UNRESOLVED |
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- Active surveillance
- description
- Newly diagnosed low risk prostate cancer patients managed according to an active surveillance program
- interventionNames
- Other: Active surveillance
- label
- Radical prostatectomy
- description
- Newly diagnosed low risk prostate cancer patients undergoing radical prostatectomy
- interventionNames
- Procedure: Radical prostatectomy
- label
- Radiotherapy
- description
- Newly diagnosed low risk prostate cancer patients undergoing radiotherapy (external or brachitherapy)
- interventionNames
- Radiation: Radiotherapy
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
IInclusion Criteria: 1. Newly diagnosed low risk prostate cancer patients, defined according to the presence of all the following criteria: * diagnosis of adenocarcinoma of the prostate * prostate cancer clinical stage T1c o T2a * PSA \<=10ng/ml at diagnosis * adequate biopsy sampling according to prostate volume * maximum of two positive cores for random sampling and of maximum two lesions for target biopsies (even if the number of positive samples if \>2) * Gleason grade 3+3 ( in patients age\>70 Gleason 3+4) 2. Residence in Piemonte or Valle D'Aosta regions; 3. Patients suitable for radical treatment (surgery or radiotherapy); 4. Age at diagnosis \<= 75 years or \>75 years if fragility assessment (measured with the G8 score)\> = 14; 5. Patients suitability for expressing a valid consent to participate in the study. Exclusion Criteria: 1. Patients previously treated for prostate cancer. 2. Patients not willing to undergo radical treatments (surgery or radiotherapy).
References
Publications (0)
Data not yet available
No reference posted for this study.