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

Condition(s) studied

Study 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.

Eligibility

Primary outcome measure(s)

• Hematologic toxicity — 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 — 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.

Trial sites (1)

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