Know Cancer

forgot password

A Phase I Trial to Evaluate Acute and Late Toxicities of Concurrent Treatment With Everolimus (RAD001) and Radio-Hormonotherapy in High-risk Prostate Cancer.

Phase 1
80 Years
Open (Enrolling)
Prostate Cancer

Thank you

Trial Information

A Phase I Trial to Evaluate Acute and Late Toxicities of Concurrent Treatment With Everolimus (RAD001) and Radio-Hormonotherapy in High-risk Prostate Cancer.



- 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.

Inclusion Criteria


- Diagnosis of high-risk, locally advanced prostate cancer meeting ≥ 1 of the following

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Primary Purpose: Treatment

Outcome Measure:

Acute and late toxicities

Safety Issue:


Principal Investigator

David Azria, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Val d'Aurelle - Paul Lamarque



Study ID:




Start Date:

January 2009

Completion Date:

Related Keywords:

  • Prostate Cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms