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

Gustavo Viani Arruda

Status and phase: Completed; Phase 3

Conditions: Prostate Cancer

Treatments: Radiation: IMRT

Study type: Interventional

Funder types: Other

Identifiers

NCT02257827

FAMEMA-0913

Details and patient eligibility

About

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.

Enrollment: 220 patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

IMRT- Hypofractionated schedule 70 Gy/25 fx

Experimental group

Description:

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.

Treatment:

Radiation: IMRT

3DCRT-Hypofractionated schedule 70 Gy/25 fx

Active Comparator group

Description:

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.

Treatment:

Radiation: IMRT