Prostate CancerIHU-WPRT-TOXNCT02803086
Longitudinal Evaluation of Intestinal, Haematological and Urinary Toxicity From Pelvic Irradiation for Prostate Cancer
An observational study of Prostate Cancer, run by IRCCS San Raffaele at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 700 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2014to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients older than 80 years at the time of enrollment
- Missing written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Experimental Design:
Hypothesis. Dose-volume histograms (DVHs) of bowel, sigmoid colon and rectum are expected to be predictive of IT prospectively self-assessed by patients by means of IBDQ (Inflammatory Bowel Disease Questionnaire). Similarly, DVHs of pelvic bony subvolumes (lumbar-sacral, iliac and the lower pelvis) should predict HT, while DVHs and dose-surface histograms (DSHs) of the bladder are expected to be predictive of UT self-assessed by patients by means of IPSS (International Prostate Symptoms Score) and ICIQ-SF (International Consultation on Incontinence Questionnaire- short form) questionnaires. Moreover, some specific urinary and intestinal-rectal symptoms are expected to lead to impairment in emotional, social and systemic domains, as assessed by the IBDQ questionnaire, more than others, with several possible "clusters" of symptoms prevailing in different treatment settings. Finally, the intestinal, urinary and hematologic toxicity profile of WPRT IMRT could emerge to be extremely different in patients treated with radical (RAD), adjuvant (ADV) or salvage (SALV) intent.
Task1. The principal aim of the project is to develop sophisticated quantitative predictive models of IT, UT and HT (without the confounding bias of chemotherapy) from WPRT IMRT in both radical and postoperative treatment of localized PCa. The possible correlation between the radiation doses received by different pelvic structures and different toxicities will be analyzed.
Task2. To try to individuate the intestinal/rectal and urinary symptoms most negatively affecting the Emotional, Social and Systemic patient domains, with the ultimate objective of "focusing" the quantitative predictive models including both clinical and physico-dosimetric parameters only upon these main symptoms. This approach could theoretically permit the creation of a "shortened and radiotherapy adapted" version of the IBDQ questionnaire.
Task3. A thorough assessment of the different self-assessed toxicity profiles to be expected in patients treated with RAD, ADV or SALV intent will be carried out, with the ultimate aim of accumulating a set of extremely detailed information to be provided to patients in order to offer them appropriate counselling after the initial diagnosis of PCa with regard to the choice between radiotherapy vs surgery. In those selecting the latter and in the presence of risk factors at prostatectomy suggesting a possible role for postoperative radiotherapy, the ultimate objective would be that of assisting patients in the always extremely problematic choice between immediate adjuvant and timely, postponed, salvage irradiation in the case of biochemical recurrence.
Task4. Secondary end-points: to search for a possible correlation between HT and IT/UT.
Throughout the treatment period, patients will be seen every 2 weeks for toxicity monitoring. Subsequently, a follow-up visit will be performed at 3 months from the end of treatment, and every six months thereafter, up to 5 years.
Intestinal and urinary toxicities, including urinary incontinence, will be self-assessed by patients by means of the Italian validated version of the IBDQ, IPSS and ICIQ-SF questionnaires: at baseline (no more than 30 days before RT start), at radiotherapy mid-point and end, at 3, 6,12, 18, 24, 30, 36, 42, 48, 54 and 60 months from radiotherapy conclusion.
A blood sample for white blood cells (WBC), with absolute neutrophil and lymphocyte counts (ANC and ALC, respectively), red blood cells (RBC) and platelets (PLT) counts will be collected at the same time intervals. In addition to the self-reported assessment of rectal/bowel and urinary symptoms during and after radiotherapy, an evaluation of acute and late IT and UT will be performed by the medical staff for possible future comparison between its subjective and objective measurement. IT, HT and UT will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.03.
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Radiotherapy, Hematopoietic stem cells, Radiotoxicity
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
Measured: 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study startFeb 2014
- Primary completionDec 2021
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Associazione Italiana per la Ricerca sul Cancro, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Regina Elena Cancer Institute, Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy, Cliniche Humanitas Gavazzeni, Centro AKTIS Diagnostica e Terapia, Azienda Sanitaria dell'Alto Adige, Azienda Sanitaria Locale TO4 di Cirie, Chivasso e Ivrea, Azienda USL Reggio Emilia - IRCCS, Candiolo Cancer Institute - IRCCS, Azienda Sanitaria Locale Biella, Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria, Azienda U.S.L. della Valle d'Aosta, IRCCS Centro di Riferimento Oncologico della Basilicata
- Responsible party
- Principal investigator, Cesare Cozzarini, IRCCS San Raffaele
- Investigators
- Cesare Cozzarini, MD, Study chair, IRCCS San Raffaele Scientific Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02803086
- Sponsor's protocol ID
- IRCCS San Raffaele
- Acronym
- IHU-WPRT-TOX
- Status last verified
- Jan 2023
- First submitted
- 8 Jun 2016
- Last updated
- 6 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 26702990Cozzarini 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.
PubMed 21109361Cozzarini 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.
PubMed 27131081Cozzarini 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.
PubMed 24985964Bresolin 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.
PubMed 33639190Munoz 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.
PubMed 34209562
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Evaluation of Intestinal, Haematological and Urinary Toxicity From Pelvic Irradiation for Prostate Cancer
- ClinicalTrials.gov ID
- NCT02803086
- Acronym / sponsor ID
- IHU-WPRT-TOX / IRCCS San Raffaele
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Radiotherapy, Hematopoietic stem cells, Radiotoxicity
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Collaborators
- Associazione Italiana per la Ricerca sul Cancro, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Regina Elena Cancer Institute, Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy, Cliniche Humanitas Gavazzeni, Centro AKTIS Diagnostica e Terapia, Azienda Sanitaria dell'Alto Adige, Azienda Sanitaria Locale TO4 di Cirie, Chivasso e Ivrea, Azienda USL Reggio Emilia - IRCCS, Candiolo Cancer Institute - IRCCS, Azienda Sanitaria Locale Biella, Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria, Azienda U.S.L. della Valle d'Aosta, IRCCS Centro di Riferimento Oncologico della Basilicata
- Study start
- Feb 2014
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Experimental Design:
Hypothesis. Dose-volume histograms (DVHs) of bowel, sigmoid colon and rectum are expected to be predictive of IT prospectively self-assessed by patients by means of IBDQ (Inflammatory Bowel Disease Questionnaire). Similarly, DVHs of pelvic bony subvolumes (lumbar-sacral, iliac and the lower pelvis) should predict HT, while DVHs and dose-surface histograms (DSHs) of the bladder are expected to be predictive of UT self-assessed by patients by means of IPSS (International Prostate Symptoms Score) and ICIQ-SF (International Consultation on Incontinence Questionnaire- short form) questionnaires. Moreover, some specific urinary and intestinal-rectal symptoms are expected to lead to impairment in emotional, social and systemic domains, as assessed by the IBDQ questionnaire, more than others, with several possible "clusters" of symptoms prevailing in different treatment settings. Finally, the intestinal, urinary and hematologic toxicity profile of WPRT IMRT could emerge to be extremely different in patients treated with radical (RAD), adjuvant (ADV) or salvage (SALV) intent.
Task1. The principal aim of the project is to develop sophisticated quantitative predictive models of IT, UT and HT (without the confounding bias of chemotherapy) from WPRT IMRT in both radical and postoperative treatment of localized PCa. The possible correlation between the radiation doses received by different pelvic structures and different toxicities will be analyzed.
Task2. To try to individuate the intestinal/rectal and urinary symptoms most negatively affecting the Emotional, Social and Systemic patient domains, with the ultimate objective of "focusing" the quantitative predictive models including both clinical and physico-dosimetric parameters only upon these main symptoms. This approach could theoretically permit the creation of a "shortened and radiotherapy adapted" version of the IBDQ questionnaire.
Task3. A thorough assessment of the different self-assessed toxicity profiles to be expected in patients treated with RAD, ADV or SALV intent will be carried out, with the ultimate aim of accumulating a set of extremely detailed information to be provided to patients in order to offer them appropriate counselling after the initial diagnosis of PCa with regard to the choice between radiotherapy vs surgery. In those selecting the latter and in the presence of risk factors at prostatectomy suggesting a possible role for postoperative radiotherapy, the ultimate objective would be that of assisting patients in the always extremely problematic choice between immediate adjuvant and timely, postponed, salvage irradiation in the case of biochemical recurrence.
Task4. Secondary end-points: to search for a possible correlation between HT and IT/UT.
Throughout the treatment period, patients will be seen every 2 weeks for toxicity monitoring. Subsequently, a follow-up visit will be performed at 3 months from the end of treatment, and every six months thereafter, up to 5 years.
Intestinal and urinary toxicities, including urinary incontinence, will be self-assessed by patients by means of the Italian validated version of the IBDQ, IPSS and ICIQ-SF questionnaires: at baseline (no more than 30 days before RT start), at radiotherapy mid-point and end, at 3, 6,12, 18, 24, 30, 36, 42, 48, 54 and 60 months from radiotherapy conclusion.
A blood sample for white blood cells (WBC), with absolute neutrophil and lymphocyte counts (ANC and ALC, respectively), red blood cells (RBC) and platelets (PLT) counts will be collected at the same time intervals. In addition to the self-reported assessment of rectal/bowel and urinary symptoms during and after radiotherapy, an evaluation of acute and late IT and UT will be performed by the medical staff for possible future comparison between its subjective and objective measurement. IT, HT and UT will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.03.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients older than 80 years at the time of enrollment
- Missing written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hematologic toxicity
Time frame: 5 years
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;
Intestinal toxicity
Time frame: 5 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
- Background: PubMed 26702990Sini 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.
- Background: PubMed 21109361Cozzarini 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.
- Background: PubMed 27131081Cozzarini 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.
- Background: PubMed 24985964Cozzarini 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.
- Background: PubMed 33639190Bresolin 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.
- Background: PubMed 34209562Munoz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cesare Cozzarini, MD study chair
IRCCS San Raffaele Scientific Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hematologic toxicity (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02803086, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2023.