Clinical trial NCT03827616: 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
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Prostatic Neoplasms
Genital Neoplasms
Keywords: Prostate cancer
Radiation therapy
Hypofractionated radiotherapy
Lead sponsor: Tatarstan Cancer Center
Sponsor class: OTHER
First posted: 2019-02-01
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

1. 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)
2. Distatnt metastases.
3. Metastases in the lymph nodes of prostate cancer.
4. Radical prostatectomy or cryodestruction of the prostate gland in history.
5. Radiation of a small pelvis in the anamnesis. Bilateral orchectomy history.
6. 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.

Primary outcomes:
measure: Biochemical Relapse Free Survival Rate
timeFrame: Analysis occurs after all patients have been followed for five year.
measure: Biochemical Relapse Free Survival Rate
timeFrame: Analysis occurs after all patients have been followed for ten year.
Secondary outcomes:
measure: Five year Local Progression Rate
timeFrame: Analysis occurs after all patients have been followed for five year.
measure: Ten year Local Progression Rate
timeFrame: Analysis occurs after all patients have been followed for ten year.
measure: Five year Overall Survival Rate
timeFrame: Analysis occurs after all patients have been followed for five year.
measure: Ten year Overall Survival Rate
timeFrame: Analysis occurs after all patients have been followed for ten year.
measure: Frequency of Patients With GU and GI Acute and Late Toxicity
timeFrame: 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.
measure: Five year Quality of life measured with EQ5D.
timeFrame: Analysis occurs after all patients have been followed for five year.
measure: Five year Quality of life measured with EPIС СP.
timeFrame: Analysis occurs after all patients have been followed for five year.
measure: Ten year Quality of life measured with EQ5D.
timeFrame: Analysis occurs after all patients have been followed for ten year.
measure: Ten year Quality of life measured with EPIС СP.
timeFrame: Analysis occurs after all patients have been followed for ten year.
Other outcomes:
Locations:
city: Kazan
country: Russian Federation
facility: Tatarstan Cancer Cente
state: Tatarstan
Study officials:
References: