Skip to content

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)

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00943956
Enrollment
30
Registered
2009-07-22
Start date
2009-01-31
Completion date
2012-12-31
Last updated
2016-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

stage III prostate cancer, stage IV prostate cancer

Brief summary

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.

Detailed description

OBJECTIVES: Primary * To assess acute and late toxicities in patients with high-risk, locally advanced prostate cancer. Secondary * To assess the biochemical-free survival of these patients. * To assess metastasis-free survival of these patients. * To assess the overall survival of these patients. * To assess the molecular characteristics of the tumor before treatment and correlate with outcomes. OUTLINE: This is a dose-escalation study of everolimus. Patients undergo radiotherapy to the prostate and seminal vesicles once daily, 5 days a week, for 7.5 weeks. Beginning the week before radiotherapy, patients receive oral bicalutamide once daily for 1 month and oral everolimus twice daily for 8.5 weeks. Beginning on the first week of radiotherapy, patients receive leuprolide acetate subcutaneously every 3 months for 2 years.

Interventions

DRUGbicalutamide
DRUGeverolimus
DRUGleuprolide acetate
RADIATIONexternal beam radiation therapy

Sponsors

Institut du Cancer de Montpellier - Val d'Aurelle
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
No minimum to 80 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Acute and late toxicities1 year

Secondary

MeasureTime frame
Biochemical-free survival1 year
Metastasis-free survival1 year
Overall survival1 year
Pre-treatment molecular characteristics of the tumor and its correlation with outcomes1 year

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026