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

Phase 3

Completed

• Conditions: Prostate Cancer
• Interventions: Radiation: IMRT

• Registration Number: NCT02257827
• Lead Sponsor: Gustavo Viani Arruda

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Study First Submitted: 2014-09-29
• Status Verified: 2014-10
• Study First Submitted QC: 2014-10-03
• Last Update Submitted: 2014-10-03
• Study First Posted: 2014-10-06
• Last Update Posted: 2014-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 220

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3DCRT-Hypofractionated schedule 70 Gy/25 fx	IMRT	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. By the linear-quadratic formula, considering an α/β ratio of 1.5 Gy for prostate cancer, 70 Gy/25 fractions is equivalent to 86 Gy in 43 fractions of 2 Gy. All patients were simulated on CT simulator.
IMRT- Hypofractionated schedule 70 Gy/25 fx	IMRT	The IMRT plan consisted of five - seven fields to deliver the same dose prescribed at the isodose line covering 95% of PTV.By the linear-quadratic formula, considering an α/β ratio of 1.5 Gy for prostate cancer, 70 Gy/25 fractions is equivalent to 86 Gy in 43 fractions of 2 Gy. All patients were simulated on CT simulator.

Primary Outcome Measures

Name	Time	Method
Gastrointestinal and geniturinary acute toxicity	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.
Gastrointestinal and geniturinary late toxicity	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 Outcome Measures

Name	Time	Method
Biochemical control	3 years	The Phoenix criteria ( nadir + 2 ng/ml of PSA) was used to define the biochemical control.

Trial Locations

Locations (1)

Faculty of Medicine of Marilia; 🇧🇷 Marilia, Sao Paulo, Brazil