Clinical trial · Interventional
Hormone Suppression and Radiation Therapy for 6 Months With/Without Docetaxel for High Risk Prostate Cancer
Docetaxel Plus 6-month Androgen Suppression and Radiation Therapy Versus 6-month Androgen Suppression and Radiation Therapy for Patients With High Risk Localized or Locally Advanced Prostate Cancer: A Randomized Controlled Trial
NCT00116142CI-TRIAL-00055919completedPhase 3Results postedClinicalTrials.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)
This randomized study is looking at the benefits of using docetaxel (chemotherapy) added to one of the standard treatments (radiation and hormones) for men with high-risk 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 |
|---|---|---|---|
| Androgen Hormonal Suppression and Radiation | Drug | — | UNRESOLVED |
| Androgen Suppression Therapy and Radiation Therapy | Drug | — | UNRESOLVED |
| Docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Arm1: Androgen Suppression Therapy + Radiation Therapy
- description
- Androgen Suppression Therapy and Radiation therapy
- interventionNames
- Drug: Androgen Hormonal Suppression and Radiation
- Drug: Androgen Suppression Therapy and Radiation Therapy
- type
- EXPERIMENTAL
- label
- Arm 2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy
- description
- Docetaxel plus androgen suppression therapy and radiation therapy
- interventionNames
- Drug: Docetaxel
- Drug: Androgen Hormonal Suppression and Radiation
- Drug: Androgen Suppression Therapy and Radiation Therapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy proven prostate cancer * Clinical Tumor Category T1b, T1c, T2a and PSA greater than (\>) 10 or Gleason score equal or greater than 4+3=7 or PSA velocity \> 2.0 ng/ml per year and also eligible patients with tumor category T2c, T3a, T3b, or T4 as per 2002 AJCC guidelines. Any minor tertiary grade of Gleason 5; Biopsy Proven or Radiographic (erMRI Seminal Vesicle Invasion); Gleason = or \> 3+4=7 with 50% or more cores positive * Negative bone scan * Lymph node assessment by CT or MR * Adequate hematologic function (Blood Counts) * Adequate liver functions (blood tests) * ECOG performance Status 0 or 1 * Peripheral neuropathy must be =\< grade 1 * PSA obtained within 3 months of entry Exclusion Criteria: * Prior history of malignancy that are \< 5 years except for cancers found to be "in-situ" and would not likely impact a patient's life expectancy with appropriate medical management. * Prior pelvic radiation therapy * Prior hormonal therapy (up to 4 weeks prior to enrollment allowed) * Individuals unable to tolerate lying still 5 - 10 minutes * Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 90.
References
Publications (4)
- DERIVEDSayan M, Chen MH, Loffredo M, McMahon E, Moningi S, Orio PF, Nguyen PL, D'Amico AV. Elective Pelvic Lymph Node Radiation Therapy and the Risk of Death in Patients With Unfavorable-Risk Prostate Cancer: A Postrandomization Analysis. J Clin Oncol. 2024 Jul 20;42(21):2558-2564. doi: 10.1200/JCO.23.02394. Epub 2024 May 1. PMID 38691823
- DERIVEDSayan M, Huang J, Xie W, Chen MH, Loffredo M, McMahon E, Orio P, Nguyen P, D'Amico AV. Risk of Short-Term Prostate-Specific Antigen Recurrence and Failure in Patients With Prostate Cancer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Oct 2;6(10):e2336390. doi: 10.1001/jamanetworkopen.2023.36390. PMID 37801315
- DERIVEDD'Amico AV, Xie W, McMahon E, Loffredo M, Medeiros S, Joseph D, Denham J, Kumar P, Bubley G, Sullivan M, Hellwig R, Carlos Vera J, Freter R, Jeffrey Baker W, Wong JY, Renshaw AA, Kantoff PW. Radiation and Androgen Deprivation Therapy With or Without Docetaxel in the Management of Nonmetastatic Unfavorable-Risk Prostate Cancer: A Prospective Randomized Trial. J Clin Oncol. 2021 Sep 10;39(26):2938-2947. doi: 10.1200/JCO.21.00596. Epub 2021 Jul 1. PMID 34197181
- DERIVEDGuttilla A, Bortolus R, Giannarini G, Ghadjar P, Zattoni F, Gnech M, Palumbo V, Valent F, Garbeglio A, Zattoni F. Multimodal treatment for high-risk prostate cancer with high-dose intensity-modulated radiation therapy preceded or not by radical prostatectomy, concurrent intensified-dose docetaxel and long-term androgen deprivation therapy: results of a prospective phase II trial. Radiat Oncol. 2014 Jan 14;9:24. doi: 10.1186/1748-717X-9-24. PMID 24423462