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Everolimus, Bicalutamide, and Leuprolide Acetate in Treating Patients Undergoing Radiation Therapy For High-Risk Locally Advanced Prostate Cancer

This study has been completed.
Information provided by (Responsible Party):
Institut du Cancer de Montpellier - Val d'Aurelle Identifier:
First received: July 21, 2009
Last updated: May 24, 2016
Last verified: May 2016

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.

Condition Intervention Phase
Prostate Cancer Drug: bicalutamide Drug: everolimus Drug: leuprolide acetate Radiation: external beam radiation therapy Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:

Further study details as provided by Institut du Cancer de Montpellier - Val d'Aurelle:

Primary Outcome Measures:
  • Acute and late toxicities [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Biochemical-free survival [ Time Frame: 1 year ]
  • Metastasis-free survival [ Time Frame: 1 year ]
  • Overall survival [ Time Frame: 1 year ]
  • Pre-treatment molecular characteristics of the tumor and its correlation with outcomes [ Time Frame: 1 year ]

Enrollment: 30
Study Start Date: January 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Everolimus
Everolimus + radiation
Drug: bicalutamide Drug: everolimus Drug: leuprolide acetate Radiation: external beam radiation therapy

Detailed Description:



  • To assess acute and late toxicities in patients with high-risk, locally advanced prostate cancer.


  • 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.


Ages Eligible for Study:   up to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00943956

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
Sponsors and Collaborators
Institut du Cancer de Montpellier - Val d'Aurelle
Principal Investigator: David Azria, MD, PhD Institut du Cancer de Montpellier - Val d'Aurelle
  More Information

Responsible Party: Institut du Cancer de Montpellier - Val d'Aurelle Identifier: NCT00943956     History of Changes
Other Study ID Numbers: CDR0000639358
CRAD001 C2486
Study First Received: July 21, 2009
Last Updated: May 24, 2016

Keywords provided by Institut du Cancer de Montpellier - Val d'Aurelle:
stage III prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Antineoplastic Agents, Hormonal
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on September 21, 2017