Clinical trial · Interventional
Everolimus, Bicalutamide, and Leuprolide Acetate in Treating Patients Undergoing Radiation Therapy For High-Risk Locally Advanced Prostate Cancer
A Phase I Trial to Evaluate Acute and Late Toxicities of Concurrent Treatment With Everolimus (RAD001) and Radio-Hormonotherapy in High-risk Prostate Cancer.(RHOMUS)
- 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: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide and leuprolide acetate may lessen the amount of androgens made by the body. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving everolimus together with bicalutamide, leuprolide acetate, and radiation therapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when given together with bicalutamide and leuprolide acetate in treating patients with high-risk locally advanced prostate cancer undergoing radiation therapy.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bicalutamide | Drug | Bicalutamide | ALIAS |
| everolimus | Drug | Everolimus | ALIAS |
| external beam radiation therapy | Radiation | — | UNRESOLVED |
| leuprolide acetate | Drug | Leuprolide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Everolimus
- description
- Everolimus + radiation
- interventionNames
- Drug: bicalutamide
- Drug: everolimus
- Drug: leuprolide acetate
- Radiation: external beam radiation therapy
Primary outcomes (1)
- measure
- Acute and late toxicities
- timeFrame
- 1 year
Secondary outcomes (4)
- measure
- Biochemical-free survival
- timeFrame
- 1 year
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Maximum age
- 80 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of high-risk, locally advanced prostate cancer meeting ≥ 1 of the following criteria: * Clinical stage ≥ T3 * Gleason score ≥ 8 * PSA ≥ 20 ng/mL * Previously untreated disease * Non-metastatic disease as assessed by bone scan and CT scan of the thorax and abdomen * Negative pelvic lymph nodes as proven by pathological analysis PATIENT CHARACTERISTICS: * WHO performance status 0-1 * WBC ≥ 3.5 x 10\^9/L * ANC ≥ 1.5 x 10\^9/L * Platelets normal * Hemoglobin \> 10 g/dL * Serum bilirubin ≤ 1.5 x upper limit of normal (ULN) * Albumin ≥ 3 g/dL * Serum transaminases activity ≤ 2.5 x ULN * Alkaline phosphatase ≤ 2.5 x ULN * Serum creatinine ≤ 1.5 x ULN * Covered by national health insurance * No history of previous malignant disease, except for adequately treated basal cell carcinoma of the skin * No ≥ grade 3 hypercholesterolemia/hypertriglyceridemia or ≥ grade 2 hypercholesterolemia/hypertriglyceridemia with history of coronary artery disease (despite lipid-lowering treatment, if given) * No uncontrolled infection * No dysphagia or intestinal malabsorption * No other concurrent severe and/or uncontrolled medical disease that could compromise participation in the study (i.e., uncontrolled diabetes mellitus, uncontrolled cardiac disease \[unstable angina\], uncontrolled hypertension, congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within the past six months, chronic liver or renal disease, and active upper gastrointestinal tract ulceration) * No history of noncompliance to medical regimens * No known hypersensitivity to everolimus, sirolimus (rapamycin), or temsirolimus * No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study treatment and follow-up schedule PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 30 days since prior investigational drugs * More than 10 days since prior and no concurrent treatment with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A
References
Publications (0)
Data not yet available