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

Gustavo Viani Arruda220 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

220

Conditions

Prostate Cancer

Interventions

Eligibility

Sex: MALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Gastrointestinal and geniturinary acute toxicity

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.

Time frame: 6 months

Gastrointestinal and geniturinary late toxicity

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.

Time frame: 24 months

Secondary Outcomes

Biochemical control

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

Time frame: 3 years