Prostate Cancer
Conditions
Keywords
Hypofractionated schedule, Intensity Modulated Radiotherapy, Conformal radiotherapy
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.
Interventions
RADIATIONIMRT
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.
Sponsors
Gustavo Viani Arruda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Biochemical control | 3 years | The Phoenix criteria ( nadir + 2 ng/ml of PSA) was used to define the biochemical control. |
Countries
Brazil
Outcome results
None listed