Clinical trial · Observational
Longitudinal Evaluation of Intestinal, Haematological and Urinary Toxicity From Pelvic Irradiation for Prostate Cancer
- 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 prophylactic irradiation of pelvic lymph-nodes by means of Whole-Pelvis Radiotherapy (WPRT) in the treatment of prostate cancer (PCa) is aimed at the timely eradication of microscopic lymph-nodal metastases. Nevertheless, even though delivered by means of modern Intensity-Modulated Radiotherapy (IMRT) techniques, WPRT may result in intestinal, hematologic and urinary toxicity (IT, HT, UT, respectively) severely affecting patients' daily health-related quality-of-life (HRQoL) within the so-called and inadequately investigated Pelvic Radiation Disease. The aim of this study is to develop sophisticated predictive models of IMRT-WPRT induced patient-reported HT, IT and UT in PCa. The possible correlation between several clinical factors and radiation doses received by various pelvic structures (i.e. pelvic bones subvolumes, intestinal loops, sigmoid, rectum and bladder) and risk and severity of patient-reported IT, UT and HT will be analyzed and robust multi-variable models will be developed and internally validated. A secondary end-point will be the identification of specific symptoms affecting patients' HRQoL during irradiation and in the long term, overall and in different therapeutic settings (radical, adjuvant and salvage). Lastly, possible correlation between HT and UT/IT will be investigated.
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 (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- 1
- description
- To date, around 700 patients, who were treated with Radiotherapy for Prostate Cancer, have been enrolled. 34% of them underwent radiotherapy with radical intent, whereas the others were post-prostatectomy patients (29% adjuvant, 37% salvage). Various techniques of irradiation were used (1% 3DCRT, 6% SF-IMRT, 52% VMAT, 41% Tomotherapy) in conventional (42%, 1.7-2.0 Gy/fr.) and hypofractionated (58%, 2.1-2.7 Gy/fr.) settings. EQD2(alpha/beta=3) to prescribed PTV ranged between 64 and 93 Gy. Limph nodes were treated in the 98% of cases.
Primary outcomes (2)
- measure
- Hematologic toxicity
- timeFrame
- 5 years
- description
- if any, acute (\<within 90 days from radiotherapy completion) and late (\>90 days from radiotherapy completion) Grade 1, Grade 2 and Grade 3-4 leukopenia, neutropenia, lymphopenia, erythropenia, anemia, thrombocytopenia and clinico-dosimetric factors predicting them;
- measure
- Intestinal toxicity
- timeFrame
- 5 years
- description
- a worsening of 2 points or more with respect to baseline of the 10 IBDQ items investigating the Bowel Domain (items # 1, 5, 9, 13, 17, 20, 22, 24, 26 and 29, frequency of bowel movements, liquid defecation, abdominal cramps, abdominal pain, gas passage, abdominal bloating, rectal bleeding, urge to go to bathroom even if empty intestine, accidental soiling and nausea/feeling sick, respectively) and of the three cumulative items evaluating the impact of Bowel Symptoms on the Emotional, Social and Systemic Domains.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with with an ECOG PS 0-1 * Patients with histologically proven adenocarcinoma of the prostate * WPRT can be delivered with both static and rotational IMRT techniques such as volumetric modulated arc therapy (VMAT) or Tomotherapy * Both conventionally (1.8-2 Gy/fraction) and moderately hypo-fractionated (≤ 2.7 Gy/fraction) regimens with simultaneous integrated boost (SIB) approach are allowed; in any case the daily dose delivered to the pelvic nodes should be in the range of 1.8-2.0 Gy/fr Exclusion Criteria: * Patients older than 80 years at the time of enrollment * Missing written informed consent
References
Publications (6)
- BACKGROUNDSini C, Fiorino C, Perna L, Noris Chiorda B, Deantoni CL, Bianchi M, Sacco V, Briganti A, Montorsi F, Calandrino R, Di Muzio N, Cozzarini C. Dose-volume effects for pelvic bone marrow in predicting hematological toxicity in prostate cancer radiotherapy with pelvic node irradiation. Radiother Oncol. 2016 Jan;118(1):79-84. doi: 10.1016/j.radonc.2015.11.020. Epub 2015 Dec 15. PMID 26702990
- BACKGROUNDCozzarini C, Fiorino C, Da Pozzo LF, Alongi F, Berardi G, Bolognesi A, Briganti A, Broggi S, Deli A, Guazzoni G, Perna L, Pasetti M, Salvadori G, Montorsi F, Rigatti P, Di Muzio N. Clinical factors predicting late severe urinary toxicity after postoperative radiotherapy for prostate carcinoma: a single-institute analysis of 742 patients. Int J Radiat Oncol Biol Phys. 2012 Jan 1;82(1):191-9. doi: 10.1016/j.ijrobp.2010.09.027. Epub 2010 Nov 23. PMID 21109361
- BACKGROUNDCozzarini C, Noris Chiorda B, Sini C, Fiorino C, Briganti A, Montorsi F, Di Muzio N. Hematologic Toxicity in Patients Treated With Postprostatectomy Whole-Pelvis Irradiation With Different Intensity Modulated Radiation Therapy Techniques Is Not Negligible and Is Prolonged: Preliminary Results of a Longitudinal, Observational Study. Int J Radiat Oncol Biol Phys. 2016 Jun 1;95(2):690-5. doi: 10.1016/j.ijrobp.2016.01.022. Epub 2016 Jan 28. PMID 27131081
- BACKGROUNDCozzarini C, Fiorino C, Deantoni C, Briganti A, Fodor A, La Macchia M, Noris Chiorda B, Rancoita PM, Suardi N, Zerbetto F, Calandrino R, Montorsi F, Di Muzio N. Higher-than-expected severe (Grade 3-4) late urinary toxicity after postprostatectomy hypofractionated radiotherapy: a single-institution analysis of 1176 patients. Eur Urol. 2014 Dec;66(6):1024-30. doi: 10.1016/j.eururo.2014.06.012. Epub 2014 Jun 27. PMID 24985964
- BACKGROUNDBresolin A, Faiella A, Garibaldi E, Munoz F, Cante D, Vavassori V, Waskiewicz JM, Girelli G, Avuzzi B, Villa E, Magli A, Noris Chiorda B, Gatti M, Ferella L, Maggio A, Landoni V, Aimonetto S, Sini C, Rancati T, Sanguineti G, Valdagni R, Di Muzio N, Fiorino C, Cozzarini C. Acute patient-reported intestinal toxicity in whole pelvis IMRT for prostate cancer: Bowel dose-volume effect quantification in a multicentric cohort study. Radiother Oncol. 2021 May;158:74-82. doi: 10.1016/j.radonc.2021.02.026. Epub 2021 Feb 25.