Back to resultsModerately Hypofractionated Radiotherapy for Prostate Cancer.
Primary Purpose
Prostatic Neoplasms, Genital Neoplasms
Status
Enrolling by invitation
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
Hypofractionated IMRT using helical Tomotherapy.
Hypofractionated IMRT using helical Tomotherapy.
Sponsored by
About this trial
This is an interventional treatment trial for Prostatic Neoplasms focused on measuring Prostate cancer, Radiation therapy, Hypofractionated radiotherapy
Eligibility Criteria
Inclusion criteria:
1. Histologically confirmed adenocarcinoma of the prostate. 2 The presence of the following studies: TRUS of the prostate gland, pelvis MRI, OSG.
3 Histological evaluation of prostate biopsy with assignment of the Gleason index.
4 Clinical stage T1-3N0M0 (AJCC 7th edition). 5 ECOG performance status 0-1 6 Age limit 18 years. 7 Patient consent to participate in a clinical study.
Exclusion criteria:
- Prior or concurrent lymphomatous/hematogenous malignancy or other invasive malignancy except nonmelanomatous skin cancer or any other cancer for which the patient has been continually disease-free for ≥ 5 years (e.g., carcinoma in situ of the bladder or oral cavity)
- Distatnt metastases.
- Metastases in the lymph nodes of prostate cancer.
- Radical prostatectomy or cryodestruction of the prostate gland in history.
- Radiation of a small pelvis in the anamnesis. Bilateral orchectomy history.
- Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months, transmural myocardial infarction within the past 6 months, acute bacterial or fungal infection requiring IV antibiotics, chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study treatment, hepatic insufficiency resulting in clinical jaundice and/or coagulation defects.
Sites / Locations
- Tatarstan Cancer Cente
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
2,5 Gy
3 Gy
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
Biochemical Relapse Free Survival Rate
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).
Biochemical Relapse Free Survival Rate
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
Five year Local Progression Rate
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
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 Overall Survival Rate
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
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
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.
Five year Quality of life measured with EQ5D.
Compare quality of life of patients in 2 groups using the scale EQ5D (European Quality of Life Questionnaire).
Five year Quality of life measured with EPIС СP.
Compare quality of life of patients in 2 groups using the scale EPIС СP (Expanded Prostate Cancer Index Composite for Clinical Practice).
Ten year Quality of life measured with EQ5D.
.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.
Compare quality of life of patients in 2 groups using the scale EPIС СP (Expanded Prostate Cancer Index Composite for Clinical Practice)
Full Information
NCT ID
NCT03827616
First Posted
January 30, 2019
Last Updated
February 8, 2019
Sponsor
Tatarstan Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT03827616
Brief Title
Moderately Hypofractionated Radiotherapy for Prostate Cancer.
Official Title
A Prospective Randomized Phase II Clinical Trial of Moderately Hypofractionated Radiotherapy (70 Gy in 28 Fractions vs 60 Gy in 20 Fractions) Using Helical Tomotherapy.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 25, 2019 (Actual)
Primary Completion Date
February 1, 2029 (Anticipated)
Study Completion Date
February 1, 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tatarstan Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms, Genital Neoplasms
Keywords
Prostate cancer, Radiation therapy, Hypofractionated radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
2,5 Gy
Arm Type
Active Comparator
Arm Description
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 Title
3 Gy
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Radiation
Intervention Name(s)
Hypofractionated IMRT using helical Tomotherapy.
Intervention Description
70 Gy in 28 fractions intensity-modulated radiotherapy (IMRT)
Intervention Type
Radiation
Intervention Name(s)
Hypofractionated IMRT using helical Tomotherapy.
Intervention Description
60 Gy in 20 fractions intensity-modulated radiotherapy (IMRT) using helical Tomotherapy.
Primary Outcome Measure Information:
Title
Biochemical Relapse Free Survival Rate
Description
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).
Time Frame
Analysis occurs after all patients have been followed for five year.
Title
Biochemical Relapse Free Survival Rate
Description
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).
Time Frame
Analysis occurs after all patients have been followed for ten year.
Secondary Outcome Measure Information:
Title
Five year Local Progression Rate
Description
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.
Time Frame
Analysis occurs after all patients have been followed for five year.
Title
Ten year Local Progression Rate
Description
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.
Time Frame
Analysis occurs after all patients have been followed for ten year.
Title
Five year Overall Survival Rate
Description
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
Time Frame
Analysis occurs after all patients have been followed for five year.
Title
Ten year Overall Survival Rate
Description
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
Time Frame
Analysis occurs after all patients have been followed for ten year.
Title
Frequency of Patients With GU and GI Acute and Late Toxicity
Description
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.
Time Frame
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.
Title
Five year Quality of life measured with EQ5D.
Description
Compare quality of life of patients in 2 groups using the scale EQ5D (European Quality of Life Questionnaire).
Time Frame
Analysis occurs after all patients have been followed for five year.
Title
Five year Quality of life measured with EPIС СP.
Description
Compare quality of life of patients in 2 groups using the scale EPIС СP (Expanded Prostate Cancer Index Composite for Clinical Practice).
Time Frame
Analysis occurs after all patients have been followed for five year.
Title
Ten year Quality of life measured with EQ5D.
Description
.Compare quality of life of patients in 2 groups using the scale EQ5D (European Quality of Life Questionnaire).
Time Frame
Analysis occurs after all patients have been followed for ten year.
Title
Ten year Quality of life measured with EPIС СP.
Description
Compare quality of life of patients in 2 groups using the scale EPIС СP (Expanded Prostate Cancer Index Composite for Clinical Practice)
Time Frame
Analysis occurs after all patients have been followed for ten year.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
1. Histologically confirmed adenocarcinoma of the prostate. 2 The presence of the following studies: TRUS of the prostate gland, pelvis MRI, OSG.
3 Histological evaluation of prostate biopsy with assignment of the Gleason index.
4 Clinical stage T1-3N0M0 (AJCC 7th edition). 5 ECOG performance status 0-1 6 Age limit 18 years. 7 Patient consent to participate in a clinical study.
Exclusion criteria:
Prior or concurrent lymphomatous/hematogenous malignancy or other invasive malignancy except nonmelanomatous skin cancer or any other cancer for which the patient has been continually disease-free for ≥ 5 years (e.g., carcinoma in situ of the bladder or oral cavity)
Distatnt metastases.
Metastases in the lymph nodes of prostate cancer.
Radical prostatectomy or cryodestruction of the prostate gland in history.
Radiation of a small pelvis in the anamnesis. Bilateral orchectomy history.
Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months, transmural myocardial infarction within the past 6 months, acute bacterial or fungal infection requiring IV antibiotics, chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study treatment, hepatic insufficiency resulting in clinical jaundice and/or coagulation defects.
Facility Information:
Facility Name
Tatarstan Cancer Cente
City
Kazan
State/Province
Tatarstan
ZIP/Postal Code
420029
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Moderately Hypofractionated Radiotherapy for Prostate Cancer.
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