Clinical trial · Interventional
Hormone Therapy With or Without Docetaxel And Estramustine in Treating Patients With Prostate Cancer That is Locally Advanced or At High Risk of Relapse
Phase III Randomized Study Of Adjuvant Hormonal Therapy With And Without Docetaxel And Estramustine In Patients With Advanced Prostate Cancer Or With A High Risk Of Relapse
NCT00055731CI-TRIAL-00063285completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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 stimulate the growth of prostate cancer cells. Drugs such as nilutamide, bicalutamide, flutamide, or cyproterone may stop the adrenal glands from producing androgens. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether hormone therapy is more effective with or without chemotherapy in treating prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy with or without docetaxel and estramustine in treating patients who have prostate cancer that is locally advanced or at high risk of relapse.
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 (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| acetylsalicylic acid | Drug | Aspirin | ALIAS |
| bicalutamide | Drug | Bicalutamide | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| docetaxel | Drug | Docetaxel | ALIAS |
| Estramustine phosphate sodium | Drug | Estramustine | ALIAS |
| Goserelin Acetate | Drug | Goserelin | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Chemotherapy
- interventionNames
- Drug: bicalutamide
- Drug: Goserelin Acetate
- Drug: docetaxel
- Drug: Estramustine phosphate sodium
- Drug: acetylsalicylic acid
- Procedure: conventional surgery
- Radiation: radiation therapy
- type
- ACTIVE_COMPARATOR
- label
- Without Chemotherapy
- interventionNames
- Drug: bicalutamide
- Drug: Goserelin Acetate
- Procedure: conventional surgery
- Radiation: radiation therapy
Primary outcomes (7)
- measure
- Progression-free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 0 Years
- Maximum age
- 79 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate * Locally advanced disease or at high risk for relapse * No clinically or radiologically suspected metastases * Prior lymphadenectomy required * Meets at least 1 of the following criteria for poor prognosis: * Gleason score greater than 7 * T3 or T4 disease * Prostate-specific antigen greater than 20 ng/mL * N1 disease PATIENT CHARACTERISTICS: Age * Under 80 Performance status * ECOG 0-2 Life expectancy * More than 10 years Hematopoietic * Absolute neutrophil count greater than 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * AST and ALT no greater than 1.5 times upper limit of normal (ULN) * Bilirubin no greater than ULN Renal * Creatinine less than 1.6 mg/dL OR * Creatinine clearance greater than 60 mL/min Cardiovascular * No uncontrolled or severe cardiovascular disease * No prior thrombosis Pulmonary * No prior pulmonary embolus Other * No active infection * No intolerance to aspirin * No other prior malignancy except basal cell skin cancer * No physical or psychological condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent immunotherapy Chemotherapy * No prior chemotherapy * No other concurrent chemotherapy Endocrine therapy * No prior hormonal therapy * No other concurrent hormonal therapy Radiotherapy * Not specified Surgery * See Disease Characteristics Other * No other concurrent anticancer therapy
References
Publications (4)
- RESULTFizazi K, Lesaunier F, Delva R, Gravis G, Rolland F, Priou F, Ferrero JM, Houede N, Mourey L, Theodore C, Krakowski I, Berdah JF, Baciuchka M, Laguerre B, Flechon A, Ravaud A, Cojean-Zelek I, Oudard S, Labourey JL, Lagrange JL, Chinet-Charrot P, Linassier C, Deplanque G, Beuzeboc P, Geneve J, Davin JL, Tournay E, Culine S. A phase III trial of docetaxel-estramustine in high-risk localised prostate cancer: a planned analysis of response, toxicity and quality of life in the GETUG 12 trial. Eur J Cancer. 2012 Jan;48(2):209-17. doi: 10.1016/j.ejca.2011.10.015. Epub 2011 Nov 24. PMID 22119204
- RESULTFizazi K, Lesaunier F, Delva R, et al.: A phase III trial of docetaxel-estramustine in high-risk localized prostate cancer (GETUG 12 trial): design, tolerance, response, and quality of life (QOL). [Abstract] 2010 Genitourinary Cancers Symposium, March 5-7, 2010, San Francisco, California. A-7, 2010.
- RESULTFizazi K, Gravis G, Culine S: The GETUG 12 trial, a phase III randomized trial of docetaxel-estramustine in high-risk localized prostate cancer: clinical design and current status. [Abstract] 2006 Prostate Cancer Symposium, February 24-26, 2006, San Francisco, CA. A-153, 2006.
- DERIVEDFizazi K, Faivre L, Lesaunier F, Delva R, Gravis G, Rolland F, Priou F, Ferrero JM, Houede N, Mourey L, Theodore C, Krakowski I, Berdah JF, Baciuchka M, Laguerre B, Flechon A, Ravaud A, Cojean-Zelek I, Oudard S, Labourey JL, Chinet-Charrot P, Legouffe E, Lagrange JL, Linassier C, Deplanque G, Beuzeboc P, Davin JL, Martin AL, Habibian M, Laplanche A, Culine S. Androgen deprivation therapy plus docetaxel and estramustine versus androgen deprivation therapy alone for high-risk localised prostate cancer (GETUG 12): a phase 3 randomised controlled trial. Lancet Oncol. 2015 Jul;16(7):787-94. doi: 10.1016/S1470-2045(15)00011-X. Epub 2015 May 28. PMID 26028518