Clinical trial · Interventional
The ELDORADO (Eligard®, Docetaxel and Radiotherapy) Study
The ELDORADO (Eligard®, Docetaxel and Radiotherapy) Study: A Phase II Study of Chemo - Hormonal Therapy and Radiation in High Risk Prostate Cancer
- 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 purpose of this study is to see if sequence inversion of Intensity - modulated Radiotherapy (IMRT) for prostate cancer, can improve the safety and deliverability of concurrent docetaxel chemotherapy with long - term hormonal therapy. The hypothesis is that inverting the traditional sequence of radiotherapy can delay the time to treatment - induced bowel toxicity.
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 |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Intensity-Modulated Radiotherapy | Radiation | — | UNRESOLVED |
| Leuprolide Acetate (Eligard®) | Drug | Leuprolide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard Radiotherapy Sequence Arm
- description
- Standard sequence of radiotherapy = whole pelvic lymphatics, proximal seminal vesicles, prostate (or prostate bed) first, then prostate/prostate bed last
- interventionNames
- Drug: Docetaxel
- Drug: Leuprolide Acetate (Eligard®)
- Radiation: Intensity-Modulated Radiotherapy
- type
- EXPERIMENTAL
- label
- Experimental Radiotherapy Sequence Arm
- description
- Experimental sequence of radiotherapy = whole pelvic lymphatics, proximal seminal vesicles, prostate (or prostate bed) last, prostate/prostate bed first
- interventionNames
- Drug: Docetaxel
- Drug: Leuprolide Acetate (Eligard®)
- Radiation: Intensity-Modulated Radiotherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * A histological diagnosis of adenocarcinoma of the prostate * Life expectancy greater than 5 years. * ECOG performance status \< 1. * Signed, written informed consent prior to randomization. * Any one, or more, of the following criteria: * TNM stage T2c, T3a or T3b * Gleason score 8 to 10, as determined by central institutional review. * PSA \> 20 mcg/L, but \< 50 mcg/L. OR Have a \> 50% chance of recurrence after radical prostatectomy, as predicted by the Kattan Nomogram and * Post - op PSA \< 1.0 mcg/L. * Must be able to start protocol treatment within 6 months from date of surgery. * No evidence of metastasis, as determined by bone scan and Chest x-ray/CT abdomen/pelvis. * Adequate marrow reserve and end - organ function * Leukocytes \> 3,000/mcL. * Absolute neutrophil count \> 1,500/mcL * Platelets \> 100,000/mcL * Total bilirubin \< 1.2 x upper limit of normal for the institution. * AST(SGOT)/ALT(SGPT) greater than 1.5 X institutional upper limit of normal * Creatinine within normal institutional limits OR * Creatinine clearance \> 60 mL/min using the Crockfort - Gault formula for patients with creatinine levels above institutional normal. Exclusion Criteria: * PSA \> 50 µg/L. * Previous pelvic radiotherapy * Sensitivity to Docetaxel chemotherapy. * Grade 2 or greater NCI CTCAE version 3.0 neuropathy. * Prior malignancy within the last 5 years, other than prostate cancer, except: * Patients with adequately treated non - melanoma cutaneous malignancies. * Patients with a history of a curatively treated malignancy (including patients with superficial bladder cancer) who have not had evidence of recurrence for a minimum of 5 years. * Patients with a history of hypersensitivity to polysorbate 80. * Patients with a known history of viral hepatitis (B,C).
References
Publications (1)
- DERIVEDWilke D, Wood L, Cwajna S, Rutledge R, Hollenhorst H, Bowes D, Patil N, Ago CT, Pignol JP. Sequence Inversion to Facilitate Concurrent Radiotherapy and Systemic Therapy. A Proof of Principle Study in the Setting of a Phase II Randomized Trial in Prostate Cancer. Front Oncol. 2020 Sep 30;10:570660. doi: 10.3389/fonc.2020.570660. eCollection 2020. PMID 33102224