Temsirolimus to Reverse Androgen Insensitivity for Castration-resistant Prostate Cancer

Stopped early · Phase 1/Phase 2

Conditions studied: Prostate Cancer, Prostatic Neoplasms, Castrate-resistant Prostate Cancer (CRPC), Androgen-insensitive Prostate Cancer, Hormone-refractory Prostate Cancer, Metastatic Disease

In brief

This study evaluates if temsirolimus causes a reduction in the serum levels of prostate-specific antigen (PSA) in male subjects with castration-resistant prostate cancer (CRPC).

Key facts

Study ID

NCT01020305

Run by

Sandy Srinivas

People needed

5

Starts

2009-10-01

Expected to finish

2012-04-01

Last updated by the study team

2014-10-13

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Histologically-confirmed adenocarcinoma of the prostate, characterized as symptomatic castration-resistant prostate cancer (CRPC)
• Serum PSA ≥ 2 ng/mL
• Rising PSA on 3 consecutive occasions at least 1 week apart (not limited to the 30-day screening period)
• Failure of bilateral orchiectomy and/or therapy with an LHRH agonist and bicalutamide
• Castrate level of testosterone (< 50 ng/dL)
• Currently being treated with bicalutamide
• No prior antiandrogen therapy except bicalutamide
• Age ≥ 18 years
• Life expectancy > 6 months
• Performance status
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• OR
• Karnofsky performance status ≥ 80%
• Ability to understand and the willingness to sign a written informed consent

You may not qualify if…

• Radiotherapy for prostate cancer within 28 days prior to Day 1, except single-fraction radiotherapy for pain control
• Prior treatment with mTOR inhibitors
• Prior treatment with chemotherapy for prostate cancer
• Symptomatic bone metastases (ie, asymptomatic bone metastases are eligible)
• Visceral metastases
• Absolute neutrophil count (ANC) < 1500/uL
• Platelet count ≤ 100 x 10e9/L
• Total bilirubin ≥ 1.5 x Upper Limit of Normal (ULN)
• Alkaline phosphatase > 2.5 x ULN
• AST > 2.5 x ULN
• 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 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
• Participation in another experimental drug study either planned or within 4 weeks of the first study treatment
• Persistent Grade ≥ 1 AEs due to prior drug therapy, including investigational drugs, administered more than 14 days before study enrollment
• Previously treated or other known brain metastases
• Ongoing or active infection
• Symptomatic congestive heart failure, New York Heart Association Grade II or greater
• Unstable angina pectoris
• Cardiac arrhythmia
• Significant vascular disease (eg, aortic aneurysm, aortic dissection)
• Symptomatic peripheral vascular disease
• Psychiatric illness/social situations that would limit compliance with study requirements

Where it is running

• Stanford University School of Medicine — Stanford, California, United States

Full record on ClinicalTrials.gov

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