Longitudinal Evaluation of Intestinal, Haematological and Urinary Toxicity From Pelvic Irradiation for Prostate Cancer

NCT02803086 | Active Not Recruiting

• 1 other identifier: IRCCS San Raffaele
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

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

Prostate Cancer

Keywords

Prostate cancer; Radiotherapy; Hematopoietic stem cells; Radiotoxicity

Outcome Measures

Primary Outcomes (2)

• Hematologic toxicity

  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;

  5 years

• Intestinal toxicity

  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.

  5 years

Study Arms (1)

1

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with histologically proven adenocarcinoma of the prostate, candidate to radical or postoperative (both adjuvant and salvage) radiotherapy including prophylactic irradiation of the pelvic lymph-nodal area. The indication for WPRT will be at the discretion of the referring Radiation Oncologist.

You may qualify if:

• 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

You may not qualify if:

• Patients older than 80 years at the time of enrollment
• Missing written informed consent

Sponsors & Collaborators

• IRCCS San Raffaele: lead
• Associazione Italiana per la Ricerca sul Cancro: collaborator
• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: collaborator
• Regina Elena Cancer Institute: collaborator
• Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy: collaborator
• Cliniche Humanitas Gavazzeni: collaborator
• Centro AKTIS Diagnostica e Terapia: collaborator
• Azienda Sanitaria dell'Alto Adige: collaborator
• Azienda Sanitaria Locale To4: collaborator
• Azienda USL Reggio Emilia - IRCCS: collaborator
• Candiolo Cancer Institute - IRCCS: collaborator
• Azienda Sanitaria Locale di Biella: collaborator
• Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria: collaborator
• Azienda U.S.L. della Valle d'Aosta: collaborator
• IRCCS Centro di Riferimento Oncologico della Basilicata: collaborator

Study Sites (1)

IRCCS San Raffaele

Milan, 20132, Italy

Location

Related Publications (6)

• Sini 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 BACKGROUND

• Cozzarini 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 BACKGROUND

• Cozzarini 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 BACKGROUND

• Cozzarini 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 BACKGROUND

• Bresolin 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.

  PMID: 33639190 BACKGROUND

• Munoz F, Sanguineti G, Bresolin A, Cante D, Vavassori V, Waskiewicz JM, Girelli G, Avuzzi B, Garibaldi E, Faiella A, Villa E, Magli A, Noris Chiorda B, Gatti M, Rancati T, Valdagni R, Di Muzio NG, Fiorino C, Cozzarini C. Predictors of Patient-Reported Incontinence at Adjuvant/Salvage Radiotherapy after Prostatectomy: Impact of Time between Surgery and Radiotherapy. Cancers (Basel). 2021 Jun 29;13(13):3243. doi: 10.3390/cancers13133243.

  PMID: 34209562 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Cesare Cozzarini, MD

  IRCCS San Raffaele Scientific Institute

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 8, 2016
• First Posted: June 16, 2016
• Study Start: February 1, 2014
• Primary Completion: December 1, 2021
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 6, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)