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AzTrials

Prostate CancerNCT00967863

Radiation Therapy in Treating Patients Receiving Hormone Therapy for Prostate Cancer (GETUG-AFU 18)

A study testing 3-dimensional conformal radiation therapy and intensity-modulated radiation therapy in people with Prostate Cancer, run by UNICANCER at 25 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Read more about this study

Who is it for?
Ages 18 to 80 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
3-dimensional conformal radiation therapy and intensity-modulated radiation therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
25 sitesFrance
Study dates
Oct 2008to Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

France25 sites

  • Institut de Cancérologie de l'Ouest Paul Papin

    Angers, 49933

  • Institut Bergonie

    Bordeaux, 33076

  • Centre Francois Baclesse

    Caen, 14076

  • Centre hospitalier Métropole Savoie

    Chambéry, 73011

  • Clinique Léonard de Vinci

    Chambray-lès-Tours, 37175

  • CHU Henri Mondor

    Créteil, 94010

  • Centre Léon Bérard

    Lyon, 69373

  • Hopital La Timone

    Marseille, 13386

  • Centre de Cancérologie du Grand Montpellier

    Montpellier, 34070

  • Centre Val D'Aurelle

    Montpellier, 34298

  • Centre Azureen de Cancerologie

    Mougins, 06250

  • Chr Orleans

    Orléans, 45000

  • Hôpital Saint Louis

    Paris, 75010

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69310

  • Centre CARIO - HPCA

    Plérin, 22190

  • Hôpital Jean Bernard - CHU de Poitiers

    Poitiers, 86021

  • Centre Eugène Marquis

    Rennes, 35042

  • Centre Henri Becquerel

    Rouen, 76038

  • Centre Rene Gauducheau

    Saint-Herblain, 44800

  • Hia Begin

    Saint-Mandé, 94160

  • Institut de Cancérologie LUCIEN NEUWIRTH

    Saint-Priest-en-Jarez, 42270

  • Centre Paul Strauss

    Strasbourg, 67065

  • Clinique PASTEUR

    Toulouse, 31076

  • Ch Bretonneau

    Tours, 37044

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, 54511

Other trials in France

About this study

Official title: Phase III Study Comparing Irradiation at a Dose of 80 Gy to Irradiation at 70 Gy in Unfavorable Prostate Cancers Associated With Prolonged Hormonal Therapy

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known which dose of radiation therapy is more effective in treating patients with prostate cancer.

PURPOSE: This randomized phase III trial is comparing two radiation therapy regimens in treating patients with prostate cancer receiving hormone therapy.

Read the detailed description

OBJECTIVES:

Primary

  • Assess the impact of increasing the radiation dose 10 Gy on biochemical or clinical progression-free survival at 5 years in patients with unfavorable-risk prostate cancer receiving prolonged hormone therapy.

Secondary

  • Evaluate overall and specific survival.
  • Assess acute and late toxicities of different modalities (conformal or intensity-modulated radiotherapy).
  • Evaluate toxicities of the different doses with respect to hormonal therapy.
  • Assess the quality of life (QLQ-C30 and PR 25).

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo 80 Gy of conformal or intensity-modulated radiotherapy 5 times a week for 7-8 weeks.
  • Arm II: Patients undergo 70 Gy of conformal or intensity-modulated radiotherapy 5 times a week for 7-8 weeks.

In both arms, patients receive goserelin subcutaneously once every 3 months for up to 3 years.

After completion of study treatment, patients are followed up periodically for 10 years.

Conditions
Prostate Cancer
Being tested
3-dimensional conformal radiation therapy, intensity-modulated radiation therapy
Keywords
adenocarcinoma of the prostate, stage III prostate cancer, stage IV prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3-dimensional conformal radiation therapyRadiation

    Patients undergo radiotherapy

  • intensity-modulated radiation therapyRadiation

    Patients undergo radiotherapy

Study groups in NCT00967863
Study groupRoleWhat they receive
Arm IExperimentalPatients undergo 80 Gy of conformal or intensity-modulated radiotherapy 5 times a week for 7-8 weeks.
Receives: Radiation: 3-dimensional conformal radiation therapy; Radiation: intensity-modulated radiation therapy
Arm IIExperimentalPatients undergo 70 Gy of conformal or intensity-modulated radiotherapy 5 times a week for 7-8 weeks.
Receives: Radiation: 3-dimensional conformal radiation therapy; Radiation: intensity-modulated radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Biochemical or clinical progression-free survival at 5 years

    Measured: 5 years

Secondary outcomes (3)

  1. Overall and specific survival

    Measured: 10 years

  2. Acute and late toxicity

    Measured: 10 years

  3. Quality of life as measured by QLQ-C30 and PR 25 questionnaires

    Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2009 (estimated)
  2. Study startOct 2008
  3. Primary completionMar 2015
  4. Study completionOct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00967863
Sponsor's protocol ID
CDR0000649028 UC-0160/0706
Other IDs
FRE-FNCLCC-GETUG-18/0706, 2008-A00529-46, EU-20966
Status last verified
Jul 2026
First submitted
27 Aug 2009
Last updated
31 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

Publications

  • Hennequin C, Sargos P, Roca L, Silva M, Latorzeff I, Peiffert D, Cozzi S, Benyoucef A, Hasbini A, Supiot S, Ronchin P, Wachter T, Azria D, Magne N, Zibouche M, Vial N, Cormier L. High-dose radiotherapy in patients with high-risk prostate cancers treated with long-term androgen deprivation therapy (GETUG AFU 18): a randomised, phase 3 trial. Lancet Oncol. 2026 Sep;27(9):1158-1167. doi: 10.1016/S1470-2045(26)00277-9.

    PubMed 42636837

  • Kim S, Kong JH, Lee Y, Lee JY, Kang TW, Kong TH, Kim MH, You SH. Dose-escalated radiotherapy for clinically localized and locally advanced prostate cancer. Cochrane Database Syst Rev. 2023 Mar 8;3(3):CD012817. doi: 10.1002/14651858.CD012817.pub2.

    PubMed 36884035

Questions about this trial

What is this clinical trial studying?

A study testing 3-dimensional conformal radiation therapy and intensity-modulated radiation therapy in people with Prostate Cancer, run by UNICANCER at 25 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biochemical or clinical progression-free survival at 5 years (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00967863, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.

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