Prostate Cancer Clinical Trial
Official title:
Cultured Circulating Tumor Cells - Development of a Novel Platform for Drug Discovery and in Vitro Chemosensitivity Testing in Prostate and Other Cancers
The purpose of this study is to evaluate the number of circulating tumor cells (CTC) before
and after treatment using an experimental method for detecting CTC, compared to commercial
CTC assay results, in patients with prostate, breast or colorectal cancers.
Experiments will be done to develop a new assay technique and also test how CTC react to
commonly used drugs. This information will be analyzed to determine if the experimental
assays can be helpful in the future to predict how a patient's cancer may react to certain
treatments.
The research experiments will also attempt to grow CTC for long-term or "immortal" cell
lines that can be further studied for proteins and gene mutations related to the specific
tumor (not familial), and testing for sensitivity to drugs.
Blood samples will be collected at specific time points during routine medical care from
patients with prostate, breast, colorectal or other solid tumor cancer. Samples will also be
collected from patients with no cancer for comparison purposes. Samples for the experimental
tests will be identified only by codes and results will not be shared with participants.
Patients with prostate, breast or colorectal cancer will also have blood samples drawn for
commercial CTC assays as part of their standard care.
Status | Recruiting |
Enrollment | 220 |
Est. completion date | April 2018 |
Est. primary completion date | April 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Diagnosis of prostate cancer, breast cancer, or other cancer, OR have no cancer. All participants will be having blood drawn at Comprehensive Cancer Centers of Nevada as part of their routine care. - 18 years of age or older. - All participants must be informed of the investigational nature of this study, and must sign and give written informed consent in accordance with institutional and FDA guidelines. Exclusion Criteria: |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada |
Lead Sponsor | Collaborator |
---|---|
Oscar Goodman, Jr. | Comprehensive Cancer Centers of Nevada, Roseman University of Health Sciences |
United States,
Allard WJ, Matera J, Miller MC, Repollet M, Connelly MC, Rao C, Tibbe AG, Uhr JW, Terstappen LW. Tumor cells circulate in the peripheral blood of all major carcinomas but not in healthy subjects or patients with nonmalignant diseases. Clin Cancer Res. 2004 Oct 15;10(20):6897-904. — View Citation
Budd GT, Cristofanilli M, Ellis MJ, Stopeck A, Borden E, Miller MC, Matera J, Repollet M, Doyle GV, Terstappen LW, Hayes DF. Circulating tumor cells versus imaging--predicting overall survival in metastatic breast cancer. Clin Cancer Res. 2006 Nov 1;12(21):6403-9. — View Citation
Cohen SJ, Punt CJ, Iannotti N, Saidman BH, Sabbath KD, Gabrail NY, Picus J, Morse MA, Mitchell E, Miller MC, Doyle GV, Tissing H, Terstappen LW, Meropol NJ. Prognostic significance of circulating tumor cells in patients with metastatic colorectal cancer. Ann Oncol. 2009 Jul;20(7):1223-9. doi: 10.1093/annonc/mdn786. Epub 2009 Mar 12. — View Citation
Collette L, Burzykowski T, Carroll KJ, Newling D, Morris T, Schröder FH; European Organisation for Research and Treatment of Cancer; Limburgs Universitair Centrum; AstraZeneca Pharmaceuticals. Is prostate-specific antigen a valid surrogate end point for survival in hormonally treated patients with metastatic prostate cancer? Joint research of the European Organisation for Research and Treatment of Cancer, the Limburgs Universitair Centrum, and AstraZeneca Pharmaceuticals. J Clin Oncol. 2005 Sep 1;23(25):6139-48. — View Citation
Danila DC, Heller G, Gignac GA, Gonzalez-Espinoza R, Anand A, Tanaka E, Lilja H, Schwartz L, Larson S, Fleisher M, Scher HI. Circulating tumor cell number and prognosis in progressive castration-resistant prostate cancer. Clin Cancer Res. 2007 Dec 1;13(23):7053-8. — View Citation
de Bono JS, Scher HI, Montgomery RB, Parker C, Miller MC, Tissing H, Doyle GV, Terstappen LW, Pienta KJ, Raghavan D. Circulating tumor cells predict survival benefit from treatment in metastatic castration-resistant prostate cancer. Clin Cancer Res. 2008 Oct 1;14(19):6302-9. doi: 10.1158/1078-0432.CCR-08-0872. Erratum in: Clin Cancer Res. 2009 Feb 15;15(4):1506. — View Citation
Halabi S, Small EJ, Kantoff PW, Kattan MW, Kaplan EB, Dawson NA, Levine EG, Blumenstein BA, Vogelzang NJ. Prognostic model for predicting survival in men with hormone-refractory metastatic prostate cancer. J Clin Oncol. 2003 Apr 1;21(7):1232-7. Erratum in: J Clin Oncol. 2004 Aug 15;22(16):3434. — View Citation
Smerage JB, Hayes DF. The measurement and therapeutic implications of circulating tumour cells in breast cancer. Br J Cancer. 2006 Jan 16;94(1):8-12. Review. — View Citation
Tannock IF, de Wit R, Berry WR, Horti J, Pluzanska A, Chi KN, Oudard S, Théodore C, James ND, Turesson I, Rosenthal MA, Eisenberger MA; TAX 327 Investigators. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004 Oct 7;351(15):1502-12. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate novel CTC assay method as a predictive tool for prostate, breast and colorectal cancers. | Colony counts will be assessed using a novel 3-D assay and a commercial CTC count method (CellSearch™). Samples will be collected prior to and post initiation of treatment. Results will be evaluated for changes in CTC counts. | Completed within 12 months after last sample collected. | No |
Secondary | Sensitivity and specificity comparison | Results of the novel 3-D assay technique will be compared with results of the commercial CellSearch™ assay for patients with breast, prostate or colon cancer. Results will be evaluated for sensitivity and specificity for the particular cancer. | Baseline, post treatment (up to 12 months) | No |
Secondary | Develop in vitro assay for chemotherapy sensitivity testing | CTC will be tested for sensitivity to select drug and biologic agents with the aim to develop a useful sensitivity assay. | Baseline, post treatment (up to 12 months) | No |
Secondary | IC50 correlation with CTC response and clinical outcome | IC50 will be determined for each patient. Exploratory analyses will be performed to determine if in vitro efficacy correlates with observed CTC counts and clinical outcome. | Baseline, post treatment (up to 12 months) | No |
Secondary | Attempt growth of long-term tumor cell lines for evaluation | In samples that experience extensive CTC growth, attempts will be made to culture cell lines over the long term in flasks using culture medium and standard tissue culture approaches. | Baseline, post treatment (up to 12 months) | No |
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