Clinical trial · Interventional
Twice High Dose External Beam Radiotherapy by Image-guided Tomotherapy for Organ-confined Prostate Cancer Treatment Emulating High Dose Radiation (HDR) Brachytherapy
Twice High Dose External Beam Radiotherapy by Image-guided Tomotherapy for Organ-confined Prostate Cancer Treatment Emulating HDR Brachytherapy: Single Institution Feasibility Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): outdated, progress in clinical practice.
Summary
Brief summary (as posted)
Feasibility trial of twice high dose radiotherapy using Tomotherapy in patients with organ confined Prostate Cancer histologically proven. The study involves 2 steps: A) Assessment of safety as proportion of patients with acute ≥G3 Genito-urinary (GU) and Gastro-intestinal (GI) side effects on the first 16 enrolled patients; B) evaluation of primary and secondary objectives on overall patients.
Conditions
Conditions (3)
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 |
| Radiotherapy; Complications | — | UNRESOLVED | — |
| Tomotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| tomotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- High dose external beam Radiotherapy
- description
- Image-guided tomotherapy
- interventionNames
- Radiation: tomotherapy
Primary outcomes (2)
- measure
- occurrence of Grade ≥3 early GU toxicity
- timeFrame
- within 3 months after end of Radiotherapy
- description
- Early Grade ≥3 GU toxicity measured by Radiation Therapy Oncology Group and European Organisation for Research and Treatment of Cancer (RTOG/EORTC) toxicity scale, using a scoring range from 0 to 5 for, where 0 means an absence of radiation effects and 5 means the effects led to death
- measure
- occurrence of Grade ≥3 early GI toxicity
- timeFrame
- within 3 months after end of Radiotherapy
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed prostate adenocarcinoma (a diagnostic biopsy with at least 10 cores is needed) * Low and intermediate-risk NCCN risk categories: low-risk ( cT1-2a, Gleason Score ≤ 6 PSA \<10 ng/ml) and among those with intermediate-risk features (clinical stage T2b-c or GS 7 or PSA 10-20 ng/ml) those patients with favorable ones (a single factor for intermediate risk and GLS 3 + 4 and \<50% of biopsy cores containing cancer) will be selected. (30). * Age ≥18 years * Good performance status , Eastern Cooperative Oncology Group (ECOG) \< 2) or Karnofsky performance status (KPS) \> 70 * No previous pelvic RT * Patient not eligible to prostatectomy or patient's refusal to undergo surgery. * NO previous prostatectomy or TURP * Good urinary flow (peak flow ≥ 10 ml/s) * Previous ADT is permitted * Prostate size ≤ 60 cc * International Prostate Symptom Score ≤ 15 * Male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Nodal involvement or distant metastases (cN1 or cM1) * Extracapsular tumor or locally advanced disease (cT3-cT4) * IPSS questionnaire \> 20 * Concomitant inflammatory bowel * Prior history of chronic prostatitis * Prior history of urethral stricture * Important systemic diseases or oral anticoagulant therapy ongoing * Non-conformity to dose constraints at the treatment planning * Other invasive cancer (apart from non-melanoma skin), unless the patient has been free from disease for at least 3 years; * Abnormal complete blood count. Any of the following: platelet count less than 75,000/ml, Hb level less than 10 gm/dl, WBC less than 3.5/ml, abnormal renal function tests (creatinine \> 1.5), severe renal impairment (GFR less than 30) * Placement of pacemakers and metallic vascular clips (all contraindication to performing prostate mpMRI).
References
Publications (0)
Data not yet available