Skip to main content
OpenTrials
Completed

NCT Number: NCT02257827

Trial Comparing Intensity Modulated Radiotherapy Versus Conformal Radiotherapy to Treat Prostate Cancer With Hypofractionated Schedule

There is no randomized controlled trial (RCT) comparing Conformal Radiotherapy (3DCRT) versus the Intensity Modulated Radiotherapy (IMRT) in terms of toxicity and disease control. Data from retrospective studies show that IMRT reduces the risk of severe late complications. More recently, the results from the RTOG 0126 study have also confirmed the benefit from IMRT in reducing acute toxicity for prostate cancer treated with conventional dose escalation. Therefore, to investigate the real clinical benefit of the IMRT over 3DCRT using a hypofractionated schedule in prostate cancer, the investigators developed a RCT.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Faculty of Medicine of Marilia

Marília, São Paulo, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with diagnosis of prostate cancer
  • With age between 18-75 years classified in low
  • Intermediate and high-risk group according to their Gleason score
  • T stage and initial PSA (iPSA).
  • Low risk group included patients with Gleason score <7 / stage T1-T2a, and iPSA <10 ng/mL.
  • Intermediate risk included Gleason score < 7, or Stage T1-T2b, or iPSA level of 10-20 ng/mL
  • High-risk patients with Gleason score >7, or Stage > T2b, or iPSA >20 ng/mL.
  • All patients classified as high risk was submitted to the bone scans.

Exclusion criteria

  • Patients with metastases
  • Prior history of prostatectomy
  • Pelvic radiotherapy treatment
  • Chemotherapy treatment were excluded of this trial.

Treatment and study plan

IMRT

Radiation

The IMRT plan consisted of five - seven fields to deliver the same dose prescribed at the isodose line covering 95% of PTV.

The 3DCRT plan consisted of six fields to deliver a total dose of 70 Gy/ 25 fractions of a single daily dose of 2.8 Gy.

Other names: 3DCRT

Primary outcomes

  1. Gastrointestinal and geniturinary acute toxicity

    Time frame: 6 months

    The primary study outcome was acute treatment reactions from the beginning of treatment to 6 months after the end of treatment. Patients were seen weekly, or as required, during treatment by a radiation oncologist. Acute gastrointestinal (GI) and genitourinary (GU) toxicity were prospectively assessed and graded according to the Radiation Therapy Oncology Group scoring system for the rectum and bladder.

  2. Gastrointestinal and geniturinary late toxicity

    Time frame: 24 months

    Any toxicity developed after 6 months from radiotherapy treatment was considered as late toxicity. Late gastrointestinal (GI) and genitourinary (GU) toxicity were prospectively assessed and graded according to the Radiation Therapy Oncology Group scoring system for the rectum and bladder.

Secondary outcomes

  1. Biochemical control

    Time frame: 3 years

    The Phoenix criteria ( nadir + 2 ng/ml of PSA) was used to define the biochemical control.

Sponsors and collaborators

Lead sponsor

Gustavo Viani Arruda

Other

Registry information

Official study title

Randomized Trial Comparing Intensity Modulated Radiotherapy Versus Conformal Radiotherapy to Treat Prostate Cancer With Hypofractionated Schedule.

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Oct 6, 2014
Registry last updated
Oct 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.