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Prostate CancerPhase 3NCT00667069

Triptorelin and Radiation Therapy in Treating Patients Who Have Undergone Surgery for Intermediate-Risk Stage III or Stage IV Prostate Cancer

A Phase 3 study testing triptorelin, adjuvant therapy and 3-dimensional conformal radiation therapy in people with Prostate Cancer, run by UNICANCER at 17 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as triptorelin, may lessen the amount of androgens made by the body. Radiation therapy uses high-energy x-rays to kill tumor cells. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
triptorelin, adjuvant therapy and 3-dimensional conformal radiation therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
424 participants
Where
17 sitesFrance
Study dates
7 Apr 2008to 24 May 2022
Phase
Phase 3
Are there results?
None posted in the registry

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 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient must have undergone curative surgery for a localized adenocarcinoma of the prostate
  • pT3a, pT3b (or pT4 by reaching the bladder neck), or R1 disease (stage III or IV)
  • PSA ≤0.1 ng/mL after prostatectomy (confirmed at 1 month)
  • May receive treatment within 6 months after surgery
  • Positive margins (tumoral glands in contact with contour ink) on the surgical specimen
  • pN0 or pNx (lymph nodes resected during negative prostatectomy or lymph nodes not resected)
Show all 11Show fewer
  • No current clinical or biochemical progressive disease
  • Life expectancy ≥10 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Patient must be affiliated to the social security system
  • Patient must have received the information sheet and signed the consent form

Who cannot join

  • Patient with prostate cancer other than adenocarcinoma
  • Gleason score ≥8 and with seminal vesicles involved
  • pN1 disease (Histologically confirmed nodal invasion during initial lymph node resection)
  • pT2 disease
  • Prior surgical or chemical castration
  • Prior hormonal therapy
Show all 14Show fewer
  • Prior radiotherapy within 3 months after radical prostatectomy
  • Prior pelvic radiotherapy
  • No history of cancer (except basal cell skin cancer) within 5 years of surgery
  • No known severe hypertension uncontrolled by appropriate therapy (≥160 mm Hg systolic and/or ≥90 mm Hg diastolic)
  • Known hypersensitivity to gonadotropin-releasing hormone or its analogs
  • Contraindication to intramuscular injection
  • Concurrent participation in another interventional study
  • Patients under protective custody or guardianship, unable to comply with the specific requirements of the study or unable to understand the purpose of the study

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

France17 sites

  • Hopital Saint Andre

    Bordeaux, 33075

  • Institut Bergonie

    Bordeaux, 33076

  • Centre Regional Francois Baclesse

    Caen, 14076

  • Hopitaux Civils de Colmar

    Colmar, 68024

  • Centre Hospitalier Universitaire Henri Mondor

    Créteil, 94000

  • Centre Leon Berard

    Lyon, 69373

  • Clinique du Pont de Chaume

    Montauban, 82017

  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

    Montpellier, 34298

  • Hopital Europeen Georges Pompidou

    Paris, 75015

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • CHU Poitiers

    Poitiers, 86021

  • Centre Henri Becquerel

    Rouen, 76038

  • Centre Regional Rene Gauducheau

    Saint-Herblain, 44805

  • Institut de Cancerologie de la Loire

    Saint-Priest-en-Jarez, 42270

  • Institut Claudius Regaud

    Toulouse, 31052

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, 54511

  • Institut Gustave Roussy

    Villejuif, F-94805

Other trials in France

About this study

Official title: Randomized, Multicenter Study Comparing the Immediate Adjuvant Radiotherapy Associate With Hormonal Therapy of LH-RH Analogue (Decapeptyl® LP) vs Delayed Radiotherapy Until Biochemical Relapse Associated With Hormonal Therapy of LH-RH Analogue (Decapeptyl® LP) in Patients With Operable Prostate Cancer pT3 R1 pN0 or pNx at Intermediate Risk.

RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as triptorelin, may lessen the amount of androgens made by the body. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether giving triptorelin and radiation therapy soon after surgery or later after surgery is more effective in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying giving triptorelin and radiation therapy soon after surgery to see how well it works compared with giving them later after surgery in treating patients who have undergone surgery for intermediate-risk stage III or stage IV prostate cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Compare the efficacy, in terms of event-free survival at 5 years, of immediate radio-hormonal therapy immediately after prostatectomy for tumor pT2, R1, pN0, or pNx versus radio-hormonal therapy at biochemical relapse.

Secondary

  • Compare the overall survival of patients treated with these regimens.
  • Compare the metastasis-free survival of these patients.
  • Compare the acute and late toxicities of these regimens in these patients.
  • Compare the quality of life of patients treated with these regimens.
  • Compare the functional dependence of patients over 75 years old.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

  • Arm I (delayed treatment): Patients receive triptorelin intramuscularly on day 1 and then 3 months later. Patients also undergo conformal radiotherapy daily, 5 days a week, for 7 weeks. Treatment begins at biochemical relapse (PSA is more than 0.2 ng/mL) and before PSA is more than 2 ng/mL.
  • Arm II (immediate treatment): Patients receive treatment as in arm I, but treatment begins within 6 months after surgery.

After completion of study treatment, patients are followed for up to 5 years.

Conditions
Prostate Cancer
Being tested
triptorelin, adjuvant therapy, 3-dimensional conformal 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.

  • triptorelinDrug

    Also called Decapeptyl

  • adjuvant therapyProcedure or surgery

  • 3-dimensional conformal radiation therapyRadiation

Study groups in NCT00667069
Study groupRoleWhat they receive
A RelapseOtherRadiotherapy and Hormonotherapy only if relapse
Receives: Drug: triptorelin; Procedure: adjuvant therapy; Radiation: 3-dimensional conformal radiation therapy
B Immediate treatmentExperimentalRadiotherapy and Hormonotherapy at randomization
Receives: Drug: triptorelin; Procedure: adjuvant therapy; Radiation: 3-dimensional conformal radiation therapy

What is being measured

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

  1. Event-free survival

    The event-free survival is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse (clinical progression, biochemical progression, death)

    Measured: From randomization to disease progression or death, up to 5 years

Secondary outcomes (6)

  1. Overall survival

    The overall survival is the length of time from randomization that patients enrolled in the study are still alive.

    Measured: From randomization to death from any cause, up to 10 years

  2. Metastases-free survival

    The metastases-free survival is the length of time during and after the treatment for cancer that a patient is still alive and the cancer has not spread to other parts of the body.

    Measured: From randomization to metastases onset, up to 10 years

  3. Acute or chronic toxicity

    The National Cancer Institute-Common Terminology Criteria for Adverse Events version 3 (NCI-CTCAE v3.0) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale will assess the severity of sensory neuropathic disorders, this derivative into 5 grades determined by the investigator.

    Measured: Throughout study completion, up to 10 years

  4. Quality of life questionnaire - Core 30 (QLQ-C30)

    Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials.

    The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease.

    All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

    Measured: At baseline, 2 years, and 5 years

  5. Quality of Life Questionnaire - Prostate Cancer Module (QLQ-PR25)

    This EORTC prostate cancer specific questionnaire is intended to supplement the QLQ-C30.

    The prostate cancer module is a 25-item questionnaire designed for use among patients with localized and metastatic prostate cancer. It includes subscales assessing urinary symptoms (9 items), bowel symptoms (4 items), treatment-related symptoms (6 items), and sexual functioning (6 items). Using a 4-point Likert scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much"), patients indicate the degree to which they have experienced symptoms.

    Measured: At baseline, 2 years, and 5 years

  6. Functional dependence in patients over 75 years old

    The Lawton Instrumental Activities of Daily Living (IADL) Scale is a self-reported questionnaire to assess independent living skills for older adults. This questionnaire, composed of 31 questions organized into 8 domains (ability to use telephone, shopping, food preparation, housekeeping, laundering, mode of transportation, responsibility for own medications, and ability to handle finances), is designed to identify improvement or deterioration of a person functioning over time. Each domain is scored 0-1 for a summary score ranging from 0 (low function, dependent) to 8 (high function, independent).

    Measured: At baseline, 2 years, and 5 years

Timeline

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

  1. First posted25 Apr 2008 (estimated)
  2. Study start7 Apr 2008
  3. Primary completionApr 2020
  4. Study completion24 May 2022

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
424 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00667069
Sponsor's protocol ID
GETUG-AFU 17 - UC-0160/0702
Other IDs
2007-002495-34, CDR0000577485
Status last verified
Jun 2024
First submitted
24 Apr 2008
Last updated
5 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sargos P, Chabaud S, Latorzeff I, Magne N, Benyoucef A, Supiot S, Pasquier D, Abdiche MS, Gilliot O, Graff-Cailleaud P, Silva M, Bergerot P, Baumann P, Belkacemi Y, Azria D, Brihoum M, Soulie M, Richaud P. Adjuvant radiotherapy versus early salvage radiotherapy plus short-term androgen deprivation therapy in men with localised prostate cancer after radical prostatectomy (GETUG-AFU 17): a randomised, phase 3 trial. Lancet Oncol. 2020 Oct;21(10):1341-1352. doi: 10.1016/S1470-2045(20)30454-X.

    PubMed 33002438

  • Campillo-Gimenez B, Buscail C, Zekri O, Laguerre B, Le Prise E, De Crevoisier R, Cuggia M. Improving the pre-screening of eligible patients in order to increase enrollment in cancer clinical trials. Trials. 2015 Jan 16;16:15. doi: 10.1186/s13063-014-0535-7.

    PubMed 25592642

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing triptorelin, adjuvant therapy and 3-dimensional conformal radiation therapy in people with Prostate Cancer, run by UNICANCER at 17 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?

The sponsor lists 11 inclusion and 14 exclusion criteria. 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: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Event-free survival (time frame: From randomization to disease progression or death, up to 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 NCT00667069, 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 5 Jun 2025.

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