Clinical trial · Interventional
Short-term High Precision Radiotherapy for Early Prostate Cancer With Concomitant Boost on the Dominant Lesion
NCT01913717CI-TRIAL-00067636unknownN/AClinicalTrials.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 present research project aims to improve the current treatment for prostate-confined tumor, evaluating the safety and feasibility of a very short hypofractionated radiotherapy schedule administered with one of the best available dose delivery systems. The study will include 2 sub-studies (in-silica and clinical study) and 4 tasks.
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 |
|---|---|---|---|
| Adenocarcinoma of Prostate | Prostate Adenocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| External beam radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- External beam radiotherapy
- description
- External beam radiotherapy
- interventionNames
- Radiation: External beam radiotherapy
Primary outcomes (1)
- measure
- Acute toxicity
- timeFrame
- one month after radiotherapy
- description
- The primary outcome is the acute toxicity according to the validated scale Radiotherapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG / EORTC). It will measure the proportion of patients who experience at least one event of acute toxicity of grade 3 or 4 according to the scale RTOG / EORTC) as the maximum value of toxicity during radiation treatment or within one month after the completion of radiotherapy.
Secondary outcomes (2)
- measure
- late toxicity
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: \- Histologically confirmed adenocarcinoma of prostate, including the following 2011 National Comprehensive Cancer Network (NCCN) risk categories: very low (T1c PSA \<10 ng/ml, Gleason score \<7, fewer than 3 positive biopsy cores, \<50% cancer in each core, PSA density \<0.15 ng/ml) or low (T1-T2a, PSA \<10 ng/ml, Gleason score \<7) or intermediate (T2b or T2c, PSA between 10 and 20 ng/ml, Gleason score of 7) * cN0 and cM0 stage * Age \> 18 years * Good performance status (ECOG\< 2), * No previous pelvic radiotherapy * No previous prostatectomy * No hormonal treatment (neoadjuvant or concomitant) * No concomitant bowel inflammatory disease or other serious comorbidities * Good urinary flow (peak flow \> 10 ml/s) * No previous invasive cancer (within 5 years before the prostate cancer diagnosis) apart from non-melanoma skin malignancies. Exclusion Criteria: * Extraprostatic tumor extension (T3) or locally advanced disease (T4) * Pelvic lymph node metastasis (N1) * Distant metastasis (M1) * Urinary obstructive symptoms (IPSS \> 20) * Previous pelvic radiotherapy * Severe systemic disorders * Concomitant disorders including: chronic urinary or intestinal inflammatory conditions (for example, ulcerous recto-colitis, Crohn disease), anti-coagulant treatment (warfarin, heparin) * Previous malignancy except for skin non-melanoma cancer or 3-year disease free interval from previous malignancy like in situ cervix cancer or non muscle invasive bladder cancer * Non conformity of the radiotherapy dose distribution when compared to the dose constraints * Psychiatric disorders or any other condition that can can make unreliable the informed consent
References
Publications (6)
- DERIVEDCorrao G, Marvaso G, Zaffaroni M, Volpe S, Augugliaro M, Fodor CI, Zerini D, Vingiani A, Mistretta FA, Luzzago S, Alessi S, Pricolo P, Musi G, De Cobelli O, Renne G, Manzoni M, Petralia G, Orecchia R, Jereczek-Fossa BA. Correlation between radiological and biological features and clinical outcomes in early prostate cancer: an exploratory subgroup analysis. Neoplasma. 2022 Mar;69(2):404-411. doi: 10.4149/neo_2021_210622N828. Epub 2022 Jan 12. PMID 35014537
- DERIVEDMarvaso G, Ciardo D, Gandini S, Riva G, Frigo E, Volpe S, Fodor C, Zerini D, Rojas DP, Comi S, Cambria R, Cattani F, Musi G, De Cobelli O, Orecchia R, Jereczek-Fossa BA. Comparison of Outcomes and Toxicity Between Extreme and Moderate Radiation Therapy Hypofractionation in Localized Prostate Cancer: A Propensity Score Analysis. Int J Radiat Oncol Biol Phys. 2019 Nov 15;105(4):735-744. doi: 10.1016/j.ijrobp.2019.07.027. Epub 2019 Aug 1. PMID 31377161
- DERIVEDCremonesi M, Garibaldi C, Timmerman R, Ferrari M, Ronchi S, Grana CM, Travaini L, Gilardi L, Starzynska A, Ciardo D, Orecchia R, Jereczek-Fossa BA, Leonardi MC. Interim 18F-FDG-PET/CT during chemo-radiotherapy in the management of oesophageal cancer patients. A systematic review. Radiother Oncol. 2017 Nov;125(2):200-212. doi: 10.1016/j.radonc.2017.09.022. Epub 2017 Oct 10. PMID 29029833
- DERIVEDGaribaldi C, Ronchi S, Cremonesi M, Gilardi L, Travaini L, Ferrari M, Alterio D, Kaanders JHAM, Ciardo D, Orecchia R, Jereczek-Fossa BA, Grana CM. Interim 18F-FDG PET/CT During Chemoradiation Therapy in the Management of Head and Neck Cancer Patients: A Systematic Review. Int J Radiat Oncol Biol Phys. 2017 Jul 1;98(3):555-573. doi: 10.1016/j.ijrobp.2017.02.217. Epub 2017 Mar 4. PMID 28581396
- DERIVEDJereczek-Fossa BA, Fanetti G, Fodor C, Ciardo D, Santoro L, Francia CM, Muto M, Surgo A, Zerini D, Marvaso G, Timon G, Romanelli P, Rondi E, Comi S, Cattani F, Golino F, Mazza S, Matei DV, Ferro M, Musi G, Nole F, de Cobelli O, Ost P, Orecchia R. Salvage Stereotactic Body Radiotherapy for Isolated Lymph Node Recurrent Prostate Cancer: Single Institution Series of 94 Consecutive Patients and 124 Lymph Nodes. Clin Genitourin Cancer. 2017 Aug;15(4):e623-e632. doi: 10.1016/j.clgc.2017.01.004. Epub 2017 Jan 11.