NCT03827616Active, not recruiting
Moderately Hypofractionated Radiotherapy for Prostate Cancer.
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.
Source: ClinicalTrials.gov · Last updated 8 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 400 (actual)
- First submitted
- 30 Jan 2019
- Start date
- 25 Jan 2019
- Primary completion date
- 1 Feb 2029
- Lead sponsor
- Tatarstan Cancer Center
- Diseases
- Prostate cancer
- NCT number
- NCT03827616
What you commit to
- Study type: Interventional
- Participants enrolled: 400
- From 25 Jan 2019 to the primary completion date, 1 Feb 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- Radiation of a small pelvis in the anamnesis. Bilateral orchectomy history.
Other illness
- Metastases in the lymph nodes of prostate cancer.
- 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.
Other
- Distatnt metastases.
- Radical prostatectomy or cryodestruction of the prostate gland in history.
Who the study is looking for
- 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.
Age in the registry: 18 years to 100 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tatarstan Cancer Cente Coordinator of this site? Confirm its status | Kazan' | Russia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.