Which radiation dose is best for prostate cancer? new trial aims to find out
NCT ID NCT03827616
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This trial compares two common radiotherapy schedules for prostate cancer: 70 Gy in 28 sessions versus 60 Gy in 20 sessions. Both are already used in clinics, but it is not clear which one works better or causes fewer side effects. The study involves 400 men with early-stage prostate cancer and will track cancer recurrence over 5 to 10 years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Radiation therapy (hypofractionated intensity-modulated radiotherapy using helical tomotherapy)
- What this could lead to
- If this trial succeeds, it could help doctors choose the best radiotherapy schedule for prostate cancer, improving cancer control and reducing side effects.
- What could go wrong
- This is a phase 2 trial, so results are not definitive. Both schedules are already standard, so the difference may be small, and long-term outcomes are still being tracked.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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400 people
The number who actually took part.
- Started
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Jan 2019
- Expected to finish
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Feb 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 100 years
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Tatarstan Cancer Cente
Kazan', Tatarstan Republic, 420029, Russia
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Other studies related to the condition(s) this trial covers.
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