Moderately Hypofractionated Radiotherapy for Prostate Cancer.
- Conditions
- Prostatic NeoplasmsGenital Neoplasms
- Interventions
- Radiation: Hypofractionated IMRT using helical Tomotherapy.
- Registration Number
- NCT03827616
- Lead Sponsor
- Tatarstan Cancer Center
- Brief Summary
Radiation therapy is one of the standard treatments for men with prostate cancer. Moderately hypofractionated radiotherapy has been established to be equivalent to standard fractionated radiotherapy in several large randomized clinical trials, however different hypofractionated regimens have been used in these studies. The two most common hypofractionated regimens are 70 Gy in 28 fractions and 60 Gy in 20 fractions, both are considered standard of care, however it is not unknown which regimen is better in terms of effectiveness and toxicity. The aim of this randomized controlled clinical trial is to compare the two hypofractionated radiotherapy regimens using Helical Tomotherapy.
- Detailed Description
OBJECTIVES:
Primary
Compare the biochemical relapse free survival (DFS) of patients with prostate cancer treated with hypofractionated regimens 70 Gy in 28 fractions and 60 Gy in 20 fractions intensity-modulated radiotherapy (IMRT) using helical Tomotherapy.
Secondary
Compare time to local progression, freedom from biochemical recurrence, and disease-specific and overall survival of patients treated with these regimens.
Determine the incidence of gastrointestinal and genitourinary toxic effects in patients treated with these regimens.
OUTLINE: This is a randomized study. Patients are stratified according to TNM ( T1-3N0M0), Gleason score (6,7 (3+4), 7(4+3), 8). Before radiotherapy patients receive hormone therapy from 3 months to 6 months. Patients are randomized to 1 of 2 treatment arms.
Arm 1 hypofractionated dosing 28 fractions x 2,5 Gy over 38 days (prostate 28 x 2,5Gy - 70Gy, seminal vesicles 28 x 2Gy - 56 Gy, node lympaticus ( if Rouch formula\> 15% or N1) 28 x 1,8 Gy - 50,4 Gy).
Arm II hypofractionated dosing 20 fractions x 3 Gy over 26day (prostate 20 x 3Gy - 60Gy, seminal vesicles 20 x 2,5Gy - 50 Gy, node lympaticus ( if if Rouch formula\> 15% or N1 ) 20 x 2,2 Gy - 44 Gy).
After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- Male
- Target Recruitment
- 200
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2,5 Gy Hypofractionated IMRT using helical Tomotherapy. hypofractionated dosing 28 fractions x 2,5 Gy over 38 days (prostate 28 x 2,5Gy - 70Gy, seminal vesicles 28 x 2Gy - 56 Gy, node lympaticus ( if Rouch formula\> 15% or N1) 28 x 1,8 Gy - 50,4 Gy). 3 Gy Hypofractionated IMRT using helical Tomotherapy. hypofractionated dosing 20 fractions x 3 Gy over 26day (prostate 20 x 3Gy - 60Gy, seminal vesicles 20 x 2,5Gy - 50 Gy, node lympaticus ( if if Rouch formula\> 15% or N1 ) 20 x 2,2 Gy - 44 Gy).
- Primary Outcome Measures
Name Time Method Biochemical Relapse Free Survival Rate Analysis occurs after all patients have been followed for ten year. Determine what regime of hypofractionation will be the best 5-10 year biochemical disease free survival. Compare the results of hypofractional regimes (60Gy in 20 farctions; 70 Gy in 28 farctions).
- Secondary Outcome Measures
Name Time Method Five year Quality of life measured with EQ5D. Analysis occurs after all patients have been followed for five year. Compare quality of life of patients in 2 groups using the scale EQ5D (European Quality of Life Questionnaire).
Five year Local Progression Rate Analysis occurs after all patients have been followed for five year. Clinical criteria for local recurrence are progression (increase in palpable abnormality) at any time, failure of regression of the palpable tumor by 2 years, and redevelopment of a palpable abnormality after complete disappearance of previous abnormalities. Histologic criteria for local recurrence are presence of prostatic carcinoma upon biopsy and positive biopsy of the palpably normal prostate more than 2 years after the start of treatment. The arms were not statistically compared because of an insufficient number of events.
Ten year Local Progression Rate Analysis occurs after all patients have been followed for ten year. Clinical criteria for local recurrence are progression (increase in palpable abnormality) at any time, failure of regression of the palpable tumor by 2 years, and redevelopment of a palpable abnormality after complete disappearance of previous abnormalities. Histologic criteria for local recurrence are presence of prostatic carcinoma upon biopsy and positive biopsy of the palpably normal prostate more than 2 years after the start of treatment. The arms were not statistically compared because of an insufficient number of events.
Five year Quality of life measured with EPIС СP. Analysis occurs after all patients have been followed for five year. Compare quality of life of patients in 2 groups using the scale EPIС СP (Expanded Prostate Cancer Index Composite for Clinical Practice).
Five year Overall Survival Rate Analysis occurs after all patients have been followed for five year. Five-year rates Kaplan-Meier estimates. Overall survival (OS) was measured from study entry until the date of death. Patients still alive at the time of analysis were censored at the date of last follow-up
Ten year Overall Survival Rate Analysis occurs after all patients have been followed for ten year. Five-year rates Kaplan-Meier estimates. Overall survival (OS) was measured from study entry until the date of death. Patients still alive at the time of analysis were censored at the date of last follow-up
Frequency of Patients With GU and GI Acute and Late Toxicity Acute toxicity is measured from start of treatment to 90 days from the completion of treatment. Late toxicity is defined as toxicity occuring after 90 days from completion of treatment. Analysis occured at the time of the primary endpoint analysis. The frequency of GU and GI adverse events as defined and graded according to the National Cancer Institute СTCAE v4 were compared between treatment arms. Acute toxicity was defined as any toxicity beginning within 90 days of completion of RT, and late toxicity was defined as any toxicity beginning more than 90 days after the completion of RT. Acute and late GU and GI toxicity rates were tabulated and reported in two ways: dichotomized as \< grade 2 vs ≥ grade 2, and dichotomized as \< grade 3 vs ≥ grade 3. Higher grade indicates more severity.
Ten year Quality of life measured with EQ5D. Analysis occurs after all patients have been followed for ten year. .Compare quality of life of patients in 2 groups using the scale EQ5D (European Quality of Life Questionnaire).
Ten year Quality of life measured with EPIС СP. Analysis occurs after all patients have been followed for ten year. Compare quality of life of patients in 2 groups using the scale EPIС СP (Expanded Prostate Cancer Index Composite for Clinical Practice)
Trial Locations
- Locations (1)
Tatarstan Cancer Cente
🇷🇺Kazan, Tatarstan, Russian Federation