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There is a clear need for novel effective agents in castration-resistant prostate cancer (CRPC), an entity previously referred to as "androgen-insensitive" or "hormone-refractory" prostate cancer. While numerous therapies impact biochemical response in this disease, none improve overall survival outside of chemotherapy. The mechanisms behind progression to castration-resistance are unclear, but preclinical studies suggest that loss of the tumor suppressor gene PTEN and subsequent up-regulation of Akt, which is upstream of mTOR, may be involved in prostate cancer progression and metastasis. Based on these observations, we hypothesize that inhibition of mTOR activity with an IV mTOR inhibitor, temsirolimus, may prolong hormone sensitivity and delay disease progression. We have received approval and drug support from the NCCN and Wyeth to study temsirolimus in castration-resistant prostate cancer before antiandrogen withdrawal in a phase II, single stage, non-randomized clinical trial. Forty patients who are currently on combined androgen blockade with bicalutamide, who have evidence of disease progression by PSA or bony metastasis will receive temsirolimus weekly for 13 weeks. Because evaluating new therapies in prostate cancer is uniquely challenging given its long natural history and relatively indolent nature, this study will employ an established surrogate endpoint for efficacy, prostate-specific antigen (PSA), which will permit preliminary evaluation of this combination in fewer patients and in less time than would otherwise be possible in this disease, and additionally evaluates secondary time-to-event outcomes. By co-targeting the androgen and PTEN/Akt/mTOR signaling pathways in castration-resistant prostate cancer, we see great potential to impact this pervasive disease.
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Stanford University School of Medicine
Published on BioPortfolio: 2014-08-27T03:17:44-0400
Define the maximum tolerated dose and dose limiting side-effects of temsirolimus in combination wtih erlotinib in patients with resistant solid tumors
The aim of the trial is to determine the recommended phase II dose of weekly intravenous topotecan in combination with a fixed dose (25 mg or 15 mg) of weekly intravenous temsirolimus in p...
This is an open-label trial investigating the efficacy of temsirolimus in recurrent or refractory primary CNS lymphoma (PCNSL) after initial chemotherapy with a high-dose methotrexate cont...
This study will compare the effectiveness and safety of two different doses of temsirolimus (Torisel).
This study is being done to determine the highest safe dose of the combination of temsirolimus and axitinib; to learn the side effects when these drugs are given together; and to determine...
Recent studies have demonstrated that most patients with mucinous prostatic adenocarcinoma may have a better prognosis than those with conventional prostatic adenocarcinoma; however, the mechanism rem...
To investigate the association between metabolic syndrome (MetS) and morphological features of benign prostatic enlargement (BPE), including total prostate volume (TPV), transitional zone volume (TZV)...
Over the last several years prostate artery embolization (PAE) has been developed as a minimally invasive technique for the treatment of benign prostatic hyperplasia induced lower urinary tract sympto...
Mesenchymal tumors of the prostate are rare but often cause considerable diagnostic difficulty when encountered. These may be either benign or malignant and can arise within the prostate gland or in a...
3-year treatment outcomes of water vapor thermal therapy (Rezūm System) compared to doxazosin, finasteride and combination drug therapy for men with benign prostatic hyperplasia: cohort data from the Medical Therapy of Prostatic Symptoms (MTOPS) Trial.
This evaluation of long-term outcomes of treatment for lower urinary tract symptoms due to benign prostatic hyperplasia compares a one-time water vapor thermal therapy procedure with daily medical the...
Tissue ablation of the PROSTATE performed by ultrasound from a transducer placed in the RECTUM. The procedure is used to treat prostate cancer (PROSTATIC NEOPLASMS) and benign prostatic hypertrophy (PROSTATIC HYPERPLASIA).
Tumors or cancer of the PROSTATE.
A premalignant change arising in the prostatic epithelium, regarded as the most important and most likely precursor of prostatic adenocarcinoma. The neoplasia takes the form of an intra-acinar or ductal proliferation of secretory cells with unequivocal nuclear anaplasia, which corresponds to nuclear grade 2 and 3 invasive prostate cancer.
A nitrogen mustard linked to estradiol, usually as phosphate; used to treat prostatic neoplasms; also has radiation protective properties.
Tumors or cancer of the PROSTATE which can grow in the presence of low or residual amount of androgen hormones such as TESTOSTERONE.
Endocrine disorders are grouped into two categories: hormone imbalance - when a gland produces too much or too little of an endocrine hormone development of lesions (such as nodules or tumors) in the endocrine system, which may or may not affect...