Moderately Hypofractionated Radiotherapy for Prostate Cancer.

NCT03827616 | Active Not Recruiting

• 1 other identifier: prostata116
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Neoplasms; Genital Neoplasms

Keywords

Prostate cancer; Radiation therapy; Hypofractionated radiotherapy

Outcome Measures

Primary Outcomes (2)

• 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).

  Analysis occurs after all patients have been followed for five year.

• 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).

  Analysis occurs after all patients have been followed for ten year.

Secondary Outcomes (9)

• Five year Local Progression Rate

  Analysis occurs after all patients have been followed for five year.

• Ten year Local Progression Rate

  Analysis occurs after all patients have been followed for ten year.

• Five year Overall Survival Rate

  Analysis occurs after all patients have been followed for five year.

• Ten year Overall Survival Rate

  Analysis occurs after all patients have been followed for ten year.

• 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.

Study Arms (2)

2,5 Gy

ACTIVE COMPARATOR

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).

Radiation: Hypofractionated IMRT using helical Tomotherapy.

3 Gy

ACTIVE COMPARATOR

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).

Radiation: Hypofractionated IMRT using helical Tomotherapy.

Interventions

Hypofractionated IMRT using helical Tomotherapy. RADIATION

70 Gy in 28 fractions intensity-modulated radiotherapy (IMRT)

2,5 Gy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Histologically confirmed adenocarcinoma of the prostate. 2 The presence of the following studies: TRUS of the prostate gland, pelvis MRI, OSG.
• Histological evaluation of prostate biopsy with assignment of the Gleason index.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tatarstan Cancer Center: lead

Study Sites (1)

Tatarstan Cancer Cente

Kazan', Tatarstan Republic, 420029, Russia

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: February 1, 2019
• Study Start: January 25, 2019
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2030
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

RU (1)