The DOI matches its Crossref record; 8 of the 8 references it cites were found in a registry or an index.
Design and End Points of Clinical Trials for Patients With Progressive Prostate Cancer and Castrate Levels of Testosterone: Recommendations of the Prostate Cancer Clinical Trials Working Group
Open accessAbstract
Purpose: To update eligibility and outcome measures in trials that evaluate systemic treatment for patients with progressive prostate cancer and castrate levels of testosterone. Methods: A committee of investigators experienced in conducting trials for prostate cancer defined new consensus criteria by reviewing previous criteria, Response Evaluation Criteria in Solid Tumors (RECIST), and emerging trial data. Results: The Prostate Cancer Clinical Trials Working Group (PCWG2) recommends a two-objective paradigm: (1) controlling, relieving, or eliminating disease manifestations that are present when treatment is initiated and (2) preventing or delaying disease manifestations expected to occur. Prostate cancers progressing despite castrate levels of testosterone are considered castration resistant and not hormone refractory. Eligibility is defined using standard disease assessments to authenticate disease progression, prior treatment, distinct clinical subtypes, and predictive models. Outcomes are reported independently for prostate-specific antigen (PSA), imaging, and clinical measures, avoiding grouped categorizations such as complete or partial response. In most trials, early changes in PSA and/or pain are not acted on without other evidence of disease progression, and treatment should be continued for at least 12 weeks to ensure adequate drug exposure. Bone scans are reported as “new lesions” or “no new lesions,” changes in soft-tissue disease assessed by RECIST, and pain using validated scales. Defining eligibility for prevent/delay end points requires attention to estimated event frequency and/or random assignment to a control group. Conclusion: PCWG2 recommends increasing emphasis on time-to-event end points (ie, failure to progress) as decision aids in proceeding from phase II to phase III trials. Recommendations will evolve as data are generated on the utility of intermediate end points to predict clinical benefit.
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Cites
New Guidelines to Evaluate the Response to Treatment in Solid Tumors
Therasse, P., Arbuck, S. G., Eisenhauer, E. A., Wanders, J., Kaplan, R. S., Rubinstein, L., Verweij, J., Van Glabbeke, M., van Oosterom, A. T., Christian, M. C., et al. (2000) · JNCI: Journal of the National Cancer Institute · doi:10.1093/jnci/92.3.205 · Cited by 15,660
Docetaxel plus Prednisone or Mitoxantrone plus Prednisone for Advanced Prostate Cancer
Tannock, I. F., de Wit, R., Berry, W. R., Horti, J., Pluzanska, A., Chi, K. N., Oudard, S., Théodore, C., James, N. D., Turesson, I., et al. (2004) · New England Journal of Medicine · doi:10.1056/nejmoa040720 · Cited by 5,735
Self-citationU.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research, U.S. Department of Health and Human Services FDA Center for Biologics Evaluation and Research, & U.S. Department of Health and Human Services FDA Center for Devices and Radiological Health (2006) · Health and Quality of Life Outcomes · doi:10.1186/1477-7525-4-79 · Cited by 2,856
Bilateral orchiectomy with or without flutamide for metastatic prostate cancer.
Eisenberger, M. A., Blumenstein, B. A., Crawford, E. D., Miller, G., McLeod, D. G., Loehrer, P. J., Wilding, G., Sears, K., Culkin, D. J., Thompson, I. M., et al. (1998) · New England Journal of Medicine · doi:10.1056/nejm199810083391504 · Cited by 859
Self-citationThe Androgen Axis in Recurrent Prostate Cancer
Mohler, J. L., Gregory, C. W., Ford, O. H., Kim, D., Weaver, C. M., Petrusz, P., Wilson, E. M., & French, F. S. (2004) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-1146-03 · Cited by 675
Holzbeierlein, J., Lal, P., LaTulippe, E., Smith, A., Satagopan, J., Zhang, L., Ryan, C., Smith, S., Scher, H., Scardino, P., et al. (2004) · The American Journal of Pathology · doi:10.1016/s0002-9440(10)63112-4 · Cited by 577
Self-citationMostaghel, E. A., Page, S. T., Lin, D. W., Fazli, L., Coleman, I. M., True, L. D., Knudsen, B., Hess, D. L., Nelson, C. C., Matsumoto, A. M., et al. (2007) · Cancer Research · doi:10.1158/0008-5472.can-06-3332 · Cited by 529
Testosterone and Dihydrotestosterone Tissue Levels in Recurrent Prostate Cancer
Titus, M. A., Schell, M. J., Lih, F. B., Tomer, K. B., & Mohler, J. L. (2005) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-05-0525 · Cited by 488
Cited by
New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1)
Eisenhauer, E. A., Therasse, P., Bogaerts, J., Schwartz, L. H., Sargent, D., Ford, R., Dancey, J., Arbuck, S., Gwyther, S., Mooney, M., et al. (2009) · European Journal of Cancer · doi:10.1016/j.ejca.2008.10.026 · Cited by 29,534
Increased Survival with Enzalutamide in Prostate Cancer after Chemotherapy
Scher, H. I., Fizazi, K., Saad, F., Taplin, M.-E., Sternberg, C. N., Miller, K., de Wit, R., Mulders, P., Chi, K. N., Shore, N. D., et al. (2012) · New England Journal of Medicine · doi:10.1056/nejmoa1207506 · Cited by 4,586
Self-citationAbiraterone and Increased Survival in Metastatic Prostate Cancer
de Bono, J. S., Logothetis, C. J., Molina, A., Fizazi, K., North, S., Chu, L., Chi, K. N., Jones, R. J., Goodman, O. B., Saad, F., et al. (2011) · New England Journal of Medicine · doi:10.1056/nejmoa1014618 · Cited by 4,407
“Fluid retention and edema 241 (31) 16 (2) 2 (<1) 88 (22) 4 (1) 0”
Self-citationde Bono, J. S., Oudard, S., Ozguroglu, M., Hansen, S., Machiels, J.-P., Kocak, I., Gravis, G., Bodrogi, I., Mackenzie, M. J., Shen, L., et al. (2010) · The Lancet · doi:10.1016/s0140-6736(10)61389-x · Cited by 3,318
Enzalutamide in Metastatic Prostate Cancer before Chemotherapy
Beer, T. M., Armstrong, A. J., Rathkopf, D. E., Loriot, Y., Sternberg, C. N., Higano, C. S., Iversen, P., Bhattacharya, S., Carles, J., Chowdhury, S., et al. (2014) · New England Journal of Medicine · doi:10.1056/nejmoa1405095 · Cited by 3,028
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Metadata
- Authors
- Scher, H. I., Halabi, S., Tannock, I., Morris, M., Sternberg, C. N., Carducci, M. A., Eisenberger, M. A., Higano, C., Bubley, G. J., Dreicer, R., Petrylak, D., Kantoff, P., Basch, E., Kelly, W. K., Figg, W. D., Small, E. J., Beer, T. M., Wilding, G., Martin, A., & Hussain, M.
- Venue
- Journal of Clinical Oncology
- Published
- 2008-03-01
- Volume
- 26
- Issue
- 7
- Pages
- 1148-1159
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2167331614
- Cited by
- 2,241
- References
- 8
- FWCI
- 69.56
- Type
- journal article
- Language
- en
- Open access
- bronze
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- Scher, H. I., Halabi, S., Tannock, I., Morris, M., Sternberg, C. N., Carducci, M. A., Eisenberger, M. A., Higano, C., Bubley, G. J., Dreicer, R., Petrylak, D., Kantoff, P., Basch, E., Kelly, W. K., Figg, W. D., Small, E. J., Beer, T. M., Wilding, G., Martin, A., & Hussain, M. (2008). Design and End Points of Clinical Trials for Patients With Progressive Prostate Cancer and Castrate Levels of Testosterone: Recommendations of the Prostate Cancer Clinical Trials Working Group. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2007.12.4487
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.
