Status:
UNKNOWN
Phase II Study of RAD001 in a Neoadjuvant Setting in Men With Intermediate or High Risk Prostate Cancer
Lead Sponsor:
Sheba Medical Center
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
The mechanisms responsible for the development of hormonal refractory prostate cancer (HRPC) have been elusive. Genetic inactivation/loss of the PTEN tumor suppressor gene occurs in 30-60% of advanced...
Detailed Description
Newly diagnosed patients with prostate cancer, with localized untreated disease must be at intermediate or high risk for disease relapse based on their PSA, Gleason score, and clinical stage. Before s...
Eligibility Criteria
Inclusion
- Histologic documentation of adenocarcinoma of prostate Gleason grade 7-10
- No evidence for lymph node or distant disease
- No prior RT to pelvis or other regions
- Age \> 18 years
- Performance status ECOG 0-1
- ANC \>1500/l
- Hemoglobin \> 9.0 g/dl
- Platelets \>100,000/l
- Total Bilirubin \<1.5 x upper limits of normal
- AST or ALT \< 3 x upper limits of normal
- Creatinine \< 1.5 x upper limits of normal
- Electrolytes within 10% of normal Range
- Cholesterol \< 300
Exclusion
- Prior hormonal therapy
- Prior RT to the pelvis
- Currently active second malignancy other than non-melanoma skin cancer
- Patients who have any severe and/or uncontrolled medical conditions such as
- Unstable angina pectoris, symptomatic congestive heart failure (New York heart association grade 2 or greater failure), myocardial infarction ≤ 6 months prior to randomization, serious uncontrolled cardiac arrhythmia
- Active or uncontrolled severe infection
- Cirrhosis, chronic active hepatitis or chronic persistent hepatitis
- Severely impaired lung function
- Evidence of bleeding diathesis or coagulopathy or need of administration of full-dose anti-coagulative(s)
- Major surgical procedure, open biopsy or significant trauma within 28 days prior to day 1
- Patients with active infection, including inflammation.
- Prior therapy with mTOR inhibitors (sirolimus, temsirolimus, everolimus)
- Uncontrolled diabetes mellitus as defined by fasting serum glucose \>1.5
- Patients receiving chronic treatment with corticosteroids or another immunosuppressive agent
- Patients with a known history of HIV seropositivity
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00657982
Start Date
April 1 2008
Last Update
January 21 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sheba Medical Center
Tel Litwinsky, Tel Hashomer, Israel, 52621