Clinical Trial Detail

This is a correlative tissue protocol to collect primary and metastatic prostate cancer specimens in order to discover new biomarkers, potential drug targets, study androgen axis signaling, and evaluate resistance developing in response to systemic therapy. Analysis of acquired specimens will provide the basis for the development of improved systemic therapy for prostate cancer patients. The mechanisms for conversion of treatment-sensitive to treatment-resistant prostate cancer are poorly understood. An improved understanding of the mechanisms of resistance to drugs targeting prostate cancer will allow design and testing of new therapeutic agents. With the advent of genomics and proteomics, which enable experiments to be conducted in parallel and on a large scale, one approach to identifying targets in cancer is to compare a statistically significant number of healthy tissues samples with cancerous tissue samples, and measure differences in DNA sequence patterns, gene expression patterns including microRNAs/noncoding RNA, patterns in protein levels or differences in metabolic products. Once individual or sets of differences have been established, the next challenge is to determine which differences are normal variations in pattern; which changes are causing the cancer cell to divide or survive in an unchecked manner; and which are repercussions of the causative change. Hypotheses for "lead targets" are arrived at through statistical analyses and validation experiments in both test tubes and in animal models of disease. These experiments are costly and intensive undertakings, but have generated an enormous amount of useful information and improved the investigators' collective understanding of how tumors develop, grow and survive.

Ages Eligible for Study: 18 Years and older

Genders Eligible for Study: Male

Study Population

>/=18 years of age, local (prostate or prostate bed) recurrent CRPC or metastatic disease to soft tissue or bone at sites accessible to biopsy with minimal risk of complications, Platelet count >50,000; WBC >1,500, Hgb >8.0, INR<1.5; PTT<45

- One of the following:

- Metastatic castration sensitive prostate cancer Castration resistant prostate cancer as defined by serum testosterone < 50 ng/ml

and one of the following:

- PSA level of at least 2 ng/ml that has risen on at least 2 successive occasions at least 1 week apart.

- Evaluable disease progression by modified RECIST

- Progression of metastatic bone disease on bone scan with > 2 new lesions

Inclusion Criteria:

- 18 years of age or older and ability to adequately understand and give informed consent

- Local (prostate or prostate bed) recurrent CRPC or metastatic disease to soft tissue or bone at sites accessible to biopsy with minimal risk of complications

- Platelet count >50,000; WBC >2,000, Hgb >8.0, INR<1.5; PTT<45

- No history of excessive unexplained bleeding from previous surgery

One of the following:

1) Metastatic castration sensitive prostate cancer or;

2) Castration resistant prostate cancer as defined by serum testosterone < 50 ng/ml and one of the following:

3) PSA level of at least 2 ng/ml that has risen on at least 2 successive occasions at least 1 week apart. Evaluable disease progression by modified RECIST (Response Evaluation Criteria in Solid Tumors)

4) Progression of metastatic bone disease on bone scan with > 2 new lesions

Other eligibility criteria may apply.

- Patients unable to stop chronic anticoagulation with warfarin or lovenox for less than 3 days

- Serious or uncontrolled infection

- Treatment with a VEGF inhibitor (such as Avastin) within the past 28 days.

Other exclusion criteria may apply.