Single Agent Temsirolimus (Torisel®) in Chemotherapy-naïve Castration-Resistant Prostate Cancer Patients
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: torisel
Intervention description: Patients will receive Torisel 25 mg weekly. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion
Intervention MeSH terms: Temsirolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: prostate cancer; androgen-independent prostate cancer (AIPC) Prostate Cancer

Summary:

      This is a single institution, open label, phase II study in androgen-independent prostate
      cancer patients who are chemotherapy-naïve. Patients will receive Torisel® 25 mg weekly.
      Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or
      the investigator's discretion.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Understand and voluntarily sign an informed consent form.

          2. Age 18 years at the time of signing the informed consent form.

          3. Able to adhere to the study visit schedule and other protocol requirements.

          4. Documented prostate cancer regardless of the Gleason score

          5. Patients should be considered hormone refractory and castration-resistant. They must
             fail LHRH analogues, and anti-androgen withdrawal trial. Failure is confirmed by an
             increase in PSA value of 10% or more than the value immediately before.

          6. Patients must have measurable disease either biochemically (using PSA) and/or using
             the Response Evaluation Criteria in Solid Tumors (RECIST) criteria for visceral organ
             involvement and/or bone disease. If there is no disease to follow on scans a PSA value
             of at least 5 ng per milliliter needs to be present at baseline to be evaluated for
             PSA response.

          7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or less.

          8. Adequate liver function tests with ALT/AST being < 3x normal, total bilirubin of 1.5
             or less, and adequate renal function measured by a creatinine of 2.0 mg/dl or less.
             Alkaline phosphatase values are never exclusion criteria if it is deemed related to
             bone metastases.

          9. Patients need to have adequate bone marrow function.

               -  absolute neutrophil count (ANC) of 1000 or above,

               -  Hgb of 9.0 g/dl or above,

               -  Platelets of 100,000 or above. If other causes are affecting plts counts such as
                  autoimmune disorders, patients are allowed on study. Patients with inadequate
                  bone marrow function that is deemed related to bone marrow involvement with
                  prostate cancer (cytopenias are due to extensive marrow infiltration with
                  prostate cancer) are allowed at the investigator's discretion.

         10. Patients with other malignancies are allowed as long as there is no evidence of the
             other malignancy present at entry time, and it has been 3 years or more since the
             treatment for the other disorder was completed. Patients with non-melanoma skin
             cancers are allowed to participate in the study.

         11. Investigational therapy such as vaccines, immunotherapy, and oral targeted agents are
             allowed on this study as long as their last exposure was 4 weeks prior to study entry.
             These agents are not considered an exclusion criteria as they are not considered
             standard chemotherapy.

         12. Patients with known bone metastases are allowed to receive intravenous bisphosphonates
             such as aredia or zometa. Patients on oral bisphosphonates are also allowed.

         13. All study participants are encouraged to continue androgen deprivation with an LHRH
             analogue.

         14. Patients must agree to use a latex condom during sexual contact with a female of
             childbearing potential, even if they have had a successful vasectomy and despite the
             fact that they are on androgen deprivation.

         15. Last treatment for prostate cancer should be at least 4 weeks ago

        Exclusion Criteria:

          1. Prior systemic chemotherapy for castration Resistant Prostate Cancer (CRPC)

          2. Prior exposure to temsirolimus (TEM)

          3. Known HIV positive status or infectious hepatitis, type A, B, or C.

          4. Known brain metastases.

          5. Steroids are allowed concomitantly ONLY IF they are taken for another chronic medical
             condition (Such as chronic obstructive pulmonary disease , Multiple sclerosis…etc)

          6. Any serious medical condition, laboratory abnormality, or psychiatric illness that
             would prevent the subject from signing and understanding the informed consent form.

          7. Any condition, including the presence of laboratory abnormalities, which places the
             subject at unacceptable risk if he were to participate in the study or confounds the
             ability to interpret data from the study.

          8. Use of any other experimental drug or therapy within 28 days of baseline.