Clinical trial · Interventional
Triptorelin, Flutamide, and External-Beam Radiation Therapy or External-Beam Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| flutamide | Drug | Flutamide | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
| triptorelin | Drug | Triptorelin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- radiotherapy alone
- interventionNames
- Radiation: radiation therapy
- type
- EXPERIMENTAL
- label
- Radiotherapy + androgene deprivation
- interventionNames
- Drug: flutamide
- Drug: triptorelin
- Radiation: radiation therapy
Primary outcomes (6)
- measure
- Impact of complete androgen blockade for 4 months
- measure
- Survival, in terms of clinical or biological remission, at 5 years
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 0 Years
- Maximum age
- 74 Years
Show eligibility criteria text
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 castrationReferences
Publications (1)
- DERIVEDCampillo-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. PMID 25592642