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Can a stronger radiation blast beat aggressive prostate cancer?

NCT ID NCT00967863

Disease control Sponsor: UNICANCER Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 31, 2026 · Last updated Jul 31, 2026

Summary

This trial asks whether giving a higher dose of radiation (80 Gy) is better than the standard dose (70 Gy) for men with aggressive prostate cancer who are also receiving hormone therapy. The study includes about 500 men with unfavorable prostate cancer features, such as advanced stage, high Gleason score, or elevated PSA. Researchers will compare how long men live without their cancer progressing, as well as side effects and quality of life.

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 (3D conformal or intensity-modulated)
What this could lead to
If successful, this could establish a higher radiation dose as a more effective standard for aggressive prostate cancer, potentially improving long-term control and survival.
What could go wrong
The trial is large but results are not yet known. Higher radiation doses may increase side effects, and the benefit over the standard dose could be small or absent.

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

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

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2008

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 80 years

Sex

Male participants only

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate * Unfavorable disease, defined by at least 1 of the following criteria: * Clinical stage T3 or T4 * Gleason score ≥8 * Serum prostate-specific antigen (PSA) ≥20 ng/mL and ≤100 ng/mL * pN0 disease allowed if lymphadenectomy performed before patient began hormone therapy * No pelvic lymph nodes ≥15 mm by CT scan or MRI * No axillary lymph node involvement (pN1) * No bone metastasis * Must be starting hormonal treatment on or up to 6 months before beginning radiotherapy PATIENT CHARACTERISTICS: * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Life expectancy \>5 years * Must be enrolled in a social security program * No other cancer, except basal cell skin cancer, that has been treated or relapsed within the past 5 years * No severe uncontrolled hypertension (systolic BP ≥160 mm Hg or diastolic BP ≥90 mm Hg) * No contraindication to luteinizing hormone-releasing hormone agonists * No contraindication to pelvic irradiation (e.g., scleroderma, chronic inflammatory gastrointestinal disease) * No hip prosthesis * Must not be deprived of liberty or under guardianship * No geographical, social, or psychological reasons that would preclude follow up PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior pelvic irradiation * At least 3-4 months since prior transurethral resection * No other prior surgery for prostate cancer * No concurrent participation in another clinical trial which would require approval upon entry to this trial

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Conditions

The condition(s) this trial relates to.

prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer

Contacts and locations

Locations

  • CHU Henri Mondor

    Créteil, 94010, France

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, 54511, France

  • Centre Azureen de Cancerologie

    Mougins, 06250, France

  • Centre CARIO - HPCA

    Plérin, 22190, France

  • Centre Eugène Marquis

    Rennes, 35042, France

  • Centre Francois Baclesse

    Caen, 14076, France

  • Centre Henri Becquerel

    Rouen, 76038, France

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69310, France

  • Centre Léon Bérard

    Lyon, 69373, France

  • Centre Paul Strauss

    Strasbourg, 67065, France

  • Centre Rene Gauducheau

    Saint-Herblain, 44800, France

  • Centre Val D'Aurelle

    Montpellier, 34298, France

  • Centre de Cancérologie du Grand Montpellier

    Montpellier, 34070, France

  • Centre hospitalier Métropole Savoie

    Chambéry, 73011, France

  • Ch Bretonneau

    Tours, 37044, France

  • Chr Orleans

    Orléans, 45000, France

  • Clinique Léonard de Vinci

    Chambray-lès-Tours, 37175, France

  • Clinique PASTEUR

    Toulouse, 31076, France

  • Hia Begin

    Saint-Mandé, 94160, France

  • Hopital La Timone

    Marseille, 13386, France

  • Hôpital Jean Bernard - CHU de Poitiers

    Poitiers, 86021, France

  • Hôpital Saint Louis

    Paris, 75010, France

  • Institut Bergonie

    Bordeaux, 33076, France

  • Institut de Cancérologie LUCIEN NEUWIRTH

    Saint-Priest-en-Jarez, 42270, France

  • Institut de Cancérologie de l'Ouest Paul Papin

    Angers, 49933, France

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