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Temsirolimus, an mTOR Inhibitor, to Reverse Androgen Insensitivity in Patients With Castration-resistant Prostate Cancer

Phase 1/Phase 2
18 Years
Not Enrolling
Prostatic Neoplasms, Prostate Cancer, Prostate Cancer Localized Disease

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Trial Information

Temsirolimus, an mTOR Inhibitor, to Reverse Androgen Insensitivity in Patients With Castration-resistant Prostate Cancer

Inclusion Criteria:

- Histologically confirmed adenocarcinoma of the prostate

- Patients with asymptomatic CRPC. To be considered castration-resistant requires the
following 3 criteria:

- Failure of bilateral orchiectomy or therapy with an LHRH agonist and

- A rising PSA on 3 consecutive occasions at least 1 week apart (but not limited
to the 30 day screening period), AND

- A castrate level of testosterone (<50ng/dL)

- Currently being treated with bicalutamide

- No prior antiandrogen therapy except bicalutamide

- A minimum PSA of 2 ng/mL

- Age >= 18 years

- Life expectancy greater than 6 months

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 or Karnofsky
performance status >= 80%

- Asymptomatic bone metastases will be allowed

- Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:- Radiotherapy for prostate cancer within 28 days prior to Day 1, with
the exception of single-fraction radiotherapy given for the indication of pain control

- Prior treatment with mTOR inhibitors

- Prior treatment with chemotherapy for prostate cancer

- Symptomatic bone metastases

- Visceral metastases

- Inadequate organ function, as evidenced by any of the following at screening:

- Absolute neutrophil count (ANC) < 1500/uL

- Platelet count <= 100 x 10^9/L

- Total bilirubin >= 1.5 x ULN

- Alkaline phosphatase, AST, and/or ALT > 2.5x ULN

- Serum creatinine > 2.0 mg/dL

- Hemoglobin < 9 g/dL

- Men with reproductive potential who do not agree to use an accepted and effective
method of contraception during the study treatment period and for at least 3 months
after completion of the study treatment.

- History of other malignancies within 5 years prior to Day 1 except for tumors with a
negligible risk for metastasis or death, such as adequately controlled basal cell
carcinoma, squamous-cell carcinoma of the skin, or early-stage bladder cancer

- Current, recent (within 4 weeks of the first infusion of this study), or planned
participation in an experimental drug study.

- Persistent Grade >=1 (NCI CTCAE v3.0) AEs due to investigational drugs or other
medications that were administered more than 14 days before study enrollment.

- Known or prior treated brain metastases. Uncontrolled intercurrent illness
including, but not limited to, ongoing or active infection, symptomatic congestive
heart failure (defined as New York Heart Association Grade II or greater, see
Appendix A), unstable angina pectoris, cardiac arrhythmia, significant vascular
disease (e.g. aortic aneurysm, aortic dissection), symptomatic peripheral vascular
disease, or psychiatric illness/social situations that would limit compliance with
study requirements.

- The subject is known to be positive for the human immunodeficiency virus (HIV) and is
receiving antiretroviral therapies. Subjects known to be HIV positive who do not
require antiretroviral therapy will be eligible if they meet other entry criteria.

- Inability to comply with study and/or follow-up procedures

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PSA response at 13 weeks since Day 1 dosing. PSA response is defined as a decrease >=50% from baseline

Outcome Time Frame:

13 weeks

Safety Issue:


Principal Investigator

Dr. Sandy Srinivas

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University


United States: Food and Drug Administration

Study ID:




Start Date:

October 2009

Completion Date:

April 2012

Related Keywords:

  • Prostatic Neoplasms
  • Prostate Cancer
  • Prostate Cancer Localized Disease
  • Neoplasms
  • Prostatic Neoplasms



Stanford University School of Medicine Stanford, California  94305-5317