Prostate CancerPhase 3NCT00104741
Triptorelin, Flutamide, and External-Beam Radiation Therapy or External-Beam Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer
A Phase 3 study testing flutamide, triptorelin and radiation therapy in people with Prostate Cancer, run by UNICANCER at 31 sites in France.
Trial summary
RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as triptorelin and flutamide, may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells. Read more about this study
- Who is it for?
- Ages 0 to 74 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- flutamide, triptorelin and radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 378 participants
- Where
- 31 sitesFrance
- Study dates
- 10 Sep 2003to 15 Oct 2015
- 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 0 to 74 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed prostate cancer, meeting the following clinical staging criteria:
- Stage T1b-T1c AND prostate specific antigen (PSA) ≥ 10 ng/mL OR Stage T1b-T1c AND Gleason score ≥ 7 OR Stage T2a-T3a
- No lymph node invasion (N0 or N-)
- Patients with ≥ 10% risk by the Partin table must undergo curage
- No metastatic disease (M0) by thoracic radiography and bone scan
- PSA < 30 ng/mL
- No history of invasive cancer
PATIENT CHARACTERISTICS:
Age
- Under 75
Performance status
- ECOG 0-1
Life expectancy
- At least 10 years
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- No prior hormonal therapy
Radiotherapy
- No prior pelvic radiotherapy
Surgery
- No prior radical prostatectomy
- No prior castration
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
France31 sites
Clinique De Rochebelle
Alès, F-30100
Institut Sainte Catherine
Avignon, 84082
Hopital Louis Pasteur
Colmar, 68024
Hopitaux Civils de Colmar
Colmar, 68024
Centre Hospitalier Universitaire Henri Mondor
Créteil, 94000
Hopital Intercommunal De Creteil
Créteil, 94010
Hopital Jean Monnet
Épinal, 88021
Centre Hospitalier Intercommunal des Alpes du Sud
Gap, 05007
Centre Oscar Lambret
Lille, 59020
Centre Hospital Regional Universitaire de Limoges
Limoges, 87042
Centre Leon Berard
Lyon, 69373
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, 13273
CHU de la Timone
Marseille, 13385
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, 34298
Centre Hospitalier de Mulhouse
Mulhouse, 68051
Centre Hospitalier
Mulhouse, 68070
Centre Regional Rene Gauducheau
Nantes, 44035
Centre Antoine Lacassagne
Nice, 06088
Clinique De Valdegour
Nîmes, 30900
Hopital d'Instruction des Armees du Val de Grace
Paris, 75005
Hopital Saint-Louis
Paris, 75475
CHU Pitie-Salpetriere
Paris, 75651
Hopital Tenon
Paris, 75970
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
CHU Poitiers
Poitiers, 86021
Institut Jean Godinot
Reims, 51056
Centre Eugene Marquis
Rennes, 35064
Centre Henri Becquerel
Rouen, 76000
Institut Claudius Regaud
Toulouse, 31052
Centre Hospitalier Universitaire Bretonneau de Tours
Tours, 37044
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54511
About this study
Official title: Multicentre Randomized Trial Assessing the Efficacy of a Short Neoadjuvant and Concomitant Hormone Therapy to an Exclusive Curative Cornformational Radiotherapy of Locolized Prostate Cancer With Intermediate Prognosis
RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as triptorelin and flutamide, may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving triptorelin and flutamide together with radiation therapy may be an effective treatment for prostate cancer. It is not yet known whether giving triptorelin and flutamide together with external-beam radiation therapy is more effective than external-beam radiation therapy alone in treating prostate cancer.
PURPOSE: This randomized phase III trial is studying triptorelin, flutamide, and external-beam radiation therapy to see how well they work compared to external-beam radiation therapy alone in treating patients with stage II or stage III prostate cancer.
Read the detailed description
OBJECTIVES:
- Compare the impact of neoadjuvant androgen blockade therapy comprising triptorelin and flutamide followed by conformal external beam radiotherapy and continued androgen blockage therapy vs conformal external beam radiotherapy alone in patients with stage II or III prostate cancer.
- Compare the survival rate, in terms of 5-year clinical or biological remission, in patients treated with these regimens.
- Compare overall survival in patients treated with these regimens.
- Compare acute and late toxicity of these regimens in these patients.
- Compare quality of life of patients treated with these regimens.
- Determine the value and time-delay to obtain prostate-specific antigen nadir in patients treated with external beam radiotherapy alone.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo conformal external beam radiotherapy.
- Arm II: Patients receive androgen blockade therapy comprising triptorelin subcutaneously every 4 weeks and oral flutamide once daily. Androgen blockade therapy continues for a total of 4 months. Two months after initiation of androgen blockade therapy, patients undergo conformal external beam radiotherapy.
Quality of life is assessed.
PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study.
- Conditions
- Prostate Cancer
- Being tested
- flutamide, triptorelin, radiation therapy
- Keywords
- stage IIB prostate cancer, stage IIA prostate cancer, stage III 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.
flutamideDrug
triptorelinDrug
radiation therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| radiotherapy alone | Active comparator | Not described Receives: Radiation: radiation therapy |
| Radiotherapy + androgene deprivation | Experimental | Not described Receives: Drug: flutamide; Drug: triptorelin; Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of complete androgen blockade for 4 months
Survival, in terms of clinical or biological remission, at 5 years
Overall survival
Acute and late toxicity
Quality of life
Value and time-delay to obtain prostate-specific antigen nadir (for patients undergoing external beam radiotherapy alone)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2005 (estimated)
- Study start10 Sep 2003
- Primary completionOct 2015
- Study completion15 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 378 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernard M. Dubray, MD, PhD, Study chair, Centre Henri Becquerel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00104741
- Sponsor's protocol ID
- UC-0160/0207
- Other IDs
- FRE-FNCLCC-GETUG-14/0207, EU-20503
- Status last verified
- Feb 2021
- First submitted
- 3 Mar 2005
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Randomized Trial Assessing the Efficacy of a Short Neoadjuvant and Concomitant Hormone Therapy to an Exclusive Curative Cornformational Radiotherapy of Locolized Prostate Cancer With Intermediate Prognosis
- ClinicalTrials.gov ID
- NCT00104741
- Acronym / sponsor ID
- UC-0160/0207
- Conditions
- Prostate Cancer
- Keywords
- stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 378 participants (actual)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Study start
- 10 Sep 2003 (actual)
- Primary completion
- Oct 2015 (actual)
- Study completion
- 15 Oct 2015 (actual)
- First posted
- 4 Mar 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as triptorelin and flutamide, may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving triptorelin and flutamide together with radiation therapy may be an effective treatment for prostate cancer. It is not yet known whether giving triptorelin and flutamide together with external-beam radiation therapy is more effective than external-beam radiation therapy alone in treating prostate cancer.
PURPOSE: This randomized phase III trial is studying triptorelin, flutamide, and external-beam radiation therapy to see how well they work compared to external-beam radiation therapy alone in treating patients with stage II or stage III prostate cancer.
Detailed description
OBJECTIVES:
- Compare the impact of neoadjuvant androgen blockade therapy comprising triptorelin and flutamide followed by conformal external beam radiotherapy and continued androgen blockage therapy vs conformal external beam radiotherapy alone in patients with stage II or III prostate cancer.
- Compare the survival rate, in terms of 5-year clinical or biological remission, in patients treated with these regimens.
- Compare overall survival in patients treated with these regimens.
- Compare acute and late toxicity of these regimens in these patients.
- Compare quality of life of patients treated with these regimens.
- Determine the value and time-delay to obtain prostate-specific antigen nadir in patients treated with external beam radiotherapy alone.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo conformal external beam radiotherapy.
- Arm II: Patients receive androgen blockade therapy comprising triptorelin subcutaneously every 4 weeks and oral flutamide once daily. Androgen blockade therapy continues for a total of 4 months. Two months after initiation of androgen blockade therapy, patients undergo conformal external beam radiotherapy.
Quality of life is assessed.
PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| radiotherapy alone | Active comparator | Radiation: radiation therapy |
| Radiotherapy + androgene deprivation | Experimental | Drug: flutamide, Drug: triptorelin, Radiation: radiation therapy |
Who may qualify
- Ages
- 0 to 74 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| flutamide | Drug | Radiotherapy + androgene deprivation |
| triptorelin | Drug | Radiotherapy + androgene deprivation |
| radiation therapy | Radiation | Radiotherapy + androgene deprivation, radiotherapy alone |
Primary outcome
Impact of complete androgen blockade for 4 months
Survival, in terms of clinical or biological remission, at 5 years
Overall survival
Acute and late toxicity
Quality of life
Value and time-delay to obtain prostate-specific antigen nadir (for patients undergoing external beam radiotherapy alone)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Derived from this study: PubMed 25592642Campillo-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernard M. Dubray, MD, PhD study chair
Centre Henri Becquerel
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing flutamide, triptorelin and radiation therapy in people with Prostate Cancer, run by UNICANCER at 31 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: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 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?
Impact of complete androgen blockade for 4 months. The study lists 6 primary outcomes in all. 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 NCT00104741, which also lists 1 linked publication.
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 21 Feb 2021; AzTrials last refreshed its copy on 29 Oct 2026.