Sharper radiation beams aim to improve prostate cancer outcomes
NCT ID NCT07189598
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a new type of radiation therapy for men with high-risk prostate cancer that hasn't spread. The treatment uses advanced imaging to deliver higher radiation doses directly to the main tumor while also treating the whole pelvis. Researchers want to see if this approach is more cost-effective and improves survival compared to standard radiation therapy. About 390 men will take part in this Phase III trial.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Adaptive stereotactic body radiotherapy (SBRT) with dose escalation on the dominant prostate tumor
- What this could lead to
- If successful, this approach could offer a more effective and cost-efficient radiotherapy option for high-risk prostate cancer, potentially improving survival and reducing side effects.
- What could go wrong
- This is a Phase III trial, but results are not yet available. The new radiotherapy may not prove better than standard treatment, and there are risks of side effects from higher radiation doses to the prostate and pelvic area.
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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About 390 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Apr 2033
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 years and older
- 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: * Male. * Age ≥ 18 years * ECOG (Eastern Cooperative Oncology Group) performance status 0-2 * Histologically proven prostate adenocarcinoma, not previously treated * High-risk or very high-risk according to the National Comprehensive Cancer Network (NCCN) : * T3a / T3b (proximal extension only), * and/or ISUP (International Society of Urological Pathology) grade 4-5, * and/or PSA (Prostate-Specific Antigen) 20ng/mL * Non-metastatic, as proven by Prostate Specific Membrane Antigen (PSMA) positron emission tomography/computed tomography (PET/CT) and pelvic MRI (Magnetic Resonance Imaging) less than 2 months before starting hormone therapy * Normal testosterone levels prior to hormone therapy * Ability to give consent for inclusion in the study * Acceptance of treatment and monitoring modalities Exclusion Criteria: * Presence of nodal or distant metastases * Stage T4. * Prostate volume \> 80 cm3. * IPSS \>19/35. * Previous local treatment of prostate adenocarcinoma (HIFU (High-Intensity Focused Ultrasound), cryotherapy) * Previous TransUrethral Resection of the prostate (PTUR)). * Previous pelvic radiotherapy. * Chronic inflammatory bowel disease. * Active cardiovascular comorbidities (e.g. myocardial infarction or ischemic stroke within the last 6 months).
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Centre Eugène Marquis
RECRUITINGRennes, 35000, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Man's best friend as cancer detector: can dogs sniff out prostate cancer?
- Can a single radiation type spare prostate cancer patients from extra side effects?
- New scan could reveal hidden cancer in High-Risk prostate patients
- Promising prostate cancer combo trial pulled before starting
- New scan could revolutionize prostate cancer monitoring