Clinical trial · Interventional
A Prospective Randomized Phase III Study Comparing Hormonal Therapy +/-Docetaxel
Non-Metastatic High-Risk Prostate Cancer Patients With Biochemical Relapse Only After Local Treatment. A Prospective Randomized Phase III Study Comparing Hormonal Therapy +/-Docetaxel
- 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)
The primary objective was to evaluate the PSA (biochemical) progression-free survival (PFS) of high-risk metastasis-free PC patients, treated with LH-RH agonist for one year with or without docetaxel after prior radical prostatectomy (RP) or radiotherapy (RT). The study was powered at 80% to detect a 25% improvement in biochemical PFS for a total sample size estimated at 252 patients, with a two-sided type I error rate of 5% (non-parametric methods.
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 |
|---|---|---|---|
| Adenocarcinoma of the Prostate | Prostate Adenocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel + hormonal treatment (LH-RH agonist) | Drug | — | UNRESOLVED |
| Hormonal treatment (LH-RH agonist) | Drug | Hormone Therapy | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: Docetaxel + hormonal treatment (LH-RH agonist)
- type
- ACTIVE_COMPARATOR
- label
- 2
- interventionNames
- Drug: Hormonal treatment (LH-RH agonist)
Primary outcomes (1)
- measure
- The primary endpoint was the PSA (biochemical) progression-free survival (PFS) of high-risk metastasis-free PC patients, treated with LH-RH agonist for one year with or without docetaxel after prior radical prostatectomy (RP) or radiotherapy (RT).
- timeFrame
- Every month during 5 years.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically documented adenocarcinoma of the prostate * Previous treatment with either radical prostatectomy or radiation therapy * Salvage radiotherapy for local relapse allowed * Neoadjuvant or per radiotherapy Hormonal therapy allowed in case of more than 6 months free-interval before first rising PSA * Life expectancy of more than 12 months * Non metastatic disease documented by imaging including radionuclide bone scan * ECOG performance status 0-1 * ANC \> 1,500/mm3 * Platelet counts \> 100,000/mm3 * SGOT and/or SGPT may be up to 2.5 x ULN Patients at high risk of biological relapse defined by: * Gleason \> 8 * PSA-DT \< 6 months * Positive surgical margins * PSA velocity \> 0.75 ng/mL/year * Pathological pelvic lymph nodes involvement (pN+) * Time from initial treatment until inclusion \< 12 months Exclusion Criteria: * Prior chemotherapy by taxanes and estramustine phosphate * Documented local recurrence of prostate cancer or documented metastatic disease * History of other malignancy within the last 5 years other than curatively treated basal cell carcinoma of the skin * Active infection * Significant cardiac disease, angina pectoris or myocardial infarction within twelve months * Clinically significant neuropathy * Medical condition requiring the use of concomitant corticosteroids * Prohibited concomitant therapy with experimental drug. * Participation in another clinical trial for the period \< 30 days
References
Publications (1)
- DERIVEDOudard S, Latorzeff I, Caty A, Miglianico L, Sevin E, Hardy-Bessard AC, Delva R, Rolland F, Mouret L, Priou F, Beuzeboc P, Gravis G, Linassier C, Gomez P, Voog E, Muracciole X, Abraham C, Banu E, Ferrero JM, Ravaud A, Krakowski I, Lagrange JL, Deplanque G, Zylberait D, Bozec L, Houede N, Culine S, Elaidi R. Effect of Adding Docetaxel to Androgen-Deprivation Therapy in Patients With High-Risk Prostate Cancer With Rising Prostate-Specific Antigen Levels After Primary Local Therapy: A Randomized Clinical Trial. JAMA Oncol. 2019 May 1;5(5):623-632. doi: 10.1001/jamaoncol.2018.6607. PMID 30703190