Clinical trial · Interventional
Stereotactic Volumetric Radiotherapy in Prostate Cancer
Stereotactic Radiotherapy in Low Risk Prostate Cancer: a Phase II Study
NCT02423889CI-TRIAL-00022095completedPhase 2ClinicalTrials.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)
This is a prospective, single arm, phase II, multicentric study. It evaluates the acute and late toxicity after stereotactic radiotherapy in low risk prostate cancer patients. All participants receive a total dose of 36.25 Gy in 5 fractions, twice a week, 7.25 Gy per fraction.
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 |
|---|---|---|---|
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Stereotactic radiotherapy with a total dose of 36.25 Gy in 5 fractions (7.25 Gy per fraction, 2 fractions per week) in low risk prostate cancer patients is delivered to evaluate acute and subacute toxicty
- interventionNames
- Radiation: Radiotherapy
Primary outcomes (2)
- measure
- Acute toxicity
- timeFrame
- up to 3 months
- description
- during treatment and up to 3 month from RT end
- measure
- Late toxicity
- timeFrame
- up to 60 months
- description
- since 4 month from RT end
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histology of prostate adenocarcinoma * Age≥ 18 years * Life expectancy≥ 10 years * Clinical negative nodes (N0) * No metastasis presence (M0) * No previous pelvic radiation therapy * Total PSA≤10 ng/ml * Gleason score ≤ 6 * T1-2 * ≤ 3 positive biopsy at prostatic mapping * Signed informed consent Exclusion Criteria: * Positive nodes (N+) or metastatic disease (M+) * Inflammatory bowel disease, collagen- vascular disorders or active autoimmune disorders * Anticoagulant treatment in progress * Hip or pelvic presence of medical devices that could prevent a correct image acquisition * Symptomatic haemorrhoidal disease * Adverse reactions to iodinate or paramagnetic contrast media * Previous malignant cancer, except basocellular skin tumour or other tumours healed since 5 years * Previous pelvic radiotherapy * Psychiatric disorder that preclude to obtain informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.