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Molecular Correlates of Sensitivity and Resistance to Therapy in Prostate Cancer


N/A
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer, Metastatic Prostate Cancer

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Trial Information

Molecular Correlates of Sensitivity and Resistance to Therapy in Prostate Cancer


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:

- Metastatic castration sensitive prostate cancer or;

- 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
(Response Evaluation Criteria in Solid Tumors)

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

Exclusion Criteria:

- 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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Outcome Measure:

Tissue from biopsies and blood collection will be used to study both sensitivity and resistance to prostate cancer treatment.

Outcome Time Frame:

Blood samples and biopsies are obtained on Day 1 of the study.

Safety Issue:

No

Principal Investigator

Bruce Montgomery, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Washington

Authority:

United States: Institutional Review Board

Study ID:

UW6932

NCT ID:

NCT01050504

Start Date:

September 2009

Completion Date:

September 2015

Related Keywords:

  • Prostate Cancer
  • Metastatic Prostate Cancer
  • Prostate cancer
  • Metastatic
  • Sensitivity
  • Resistance
  • Prostatic Neoplasms

Name

Location

Harborview Medical CenterSeattle, Washington  98104
UWashingtonSeattle, Washington  98195