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2. Niraparib in patients with metastatic castration-resistant prostate cancer and DNA repair gene defects (GALAHAD): a multicentre, open-label, phase 2 trial

Author

Parnis, Francis, Joshua, Anthony M., Horvath, Lisa G., Steer, Christopher, Marx, Gavin, Sandhu, Shahneen, Gurney, Howard, Ferguson, Thomas, Van Bruwaene, Siska, Luyten, Daisy, Schatteman, Peter, Lumen, Nicolaas, Dirix, Luc, Goeminne, Jean-Charles, Gil, Thierry, Seront, Emmanuel, Vulsteke, Christof, Kussumoto, Celio, Franke, Fabio A., Martinelli de Oliveira, Fabricio Augusto, Pereira de Santana Gomes, Andrea Juliana, Pinczowski, Hélio, Preto, Daniel D'Almeida, Zucca, Luis Eduardo, Borges, Giuliano Santos, Murad, Andre M., Saad, Fred, Chi, Kim N., Fradet, Yves, Fleshner, Neil E., Emmenegger, Urban, Brasso, Klaus, Fizazi, Karim, Culine, Stephane, Thiery-Vuillemin, Antoine, Joly, Florence, Fléchon, Aude, Hilgers, Werner, Eymard, Jean-Christophe, Borchiellini, Delphine, Barthélémy, Philippe, Berger, Raanan, Leibowitz-Amit, Raya, Mermershtain, Wilmosh, Rouvinov, Keren, Peer, Avivit, Kovel, Svetlana, Sella, Avishay, Lolkema, Martijn P., van den Eertwegh, Alfonsus J.M., Voortman, Johannes, Aarts, Maureen J., Gietema, Jourik A., Kim, Choung-Soo, Choi, Young-Deuk, Chung, Byung-Ha, Gafanov, Rustem A., Kopyltsov, Evgeniy, Usynin, Evgeny A., Carles, Joan, Mellado, Begoña, Maroto, José Pablo, García-Donás, Jesús, Rodríguez Moreno, Juan Francisco, Durán, Ignacio, Pérez-Valderrama, Begoña, Castro, Elena, Olmos, David, Méndez-Vidal, María José, Estellés, David Lorente, Sarrió, Regina Gironés, Muñoz-Langa, José, Herranz, Urbano Anido, Puente Vázquez, Javier, Castellanos, Enrique, Hellström, Martin, Widmark, Anders, Lissbrant, Ingela Franck, Jellvert, Åsa, Külich, Cecilia, Blom, René, Ståhl, Olof, Chiang, Po-Hui, Kang, Chih-Hsiung, Ou, Yen-Chuan, Wang, Shian-Shiang, Wu, Hsi-Chin, Lu, Yu-Chuan, Attard, Gerhardt, Khoo, Vincent, Bahl, Amit, Kellati, Prasad, Parikh, Omi, Srinivasan, Rajaguru, Lester, Jason F., Staffurth, John N., Cheng, Heather H., Efstathiou, Eleni, Pilié, Patrick G., George, Daniel J., Karsh, Lawrence I., Kelly, W. Kevin, Danila, Daniel C., Sieber, Paul R., Smith, Matthew R., Heath, Elisabeth I., Vaishampayan, Ulka N., Flaig, Thomas W., Emamekhoo, Hamid, Pinski, Jacek K., Kalebasty, Arash Rezazadeh, Maly, Joseph J., Moon, Helen, Smith, Matthew R, Scher, Howard I, Lara, Primo N, Jr, Yu, Evan Y, George, Daniel J, Chi, Kim N, Danila, Daniel C, Mason, Gary E, Espina, Byron M, Zhao, Xin, Urtishak, Karen A, Francis, Peter, and Lopez-Gitlitz, Angela

Published
2022
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3. Potential Impact on Clinical Decision Making via a Genome-Wide Expression Profiling: A Case Report

Author

Kim, Hyun, Alshalalfa, Mohammed, Hoffman-Censits, Jean, Lallas, Costas D, Davicioni, Elai, Lin, Jianqing, Birbe, Ruth, Erho, Nicholas, Lehrer, Jonathan, Ashab, Hussam Al-Deen, Takhar, Mandeep, Olson, Anders, Lam, Lucia LC, Kelly, W Kevin, Knudsen, Karen E, Thangavel, Chellappagounder, Seiler, Roland, Feng, Felix Y, Schaeffer, Edward M, Trabulsi, Edouard J, Gomella, Leonard G, Hurwitz, Mark D, Dicker, Adam P, and Den, Robert B

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Cancer, Rare Diseases, Clinical Research, Health Services, Aging, Human Genome, Genetics, Urologic Diseases, Patient Safety, Clinical Trials and Supportive Activities, Prostate Cancer, Behavioral and Social Science, Biotechnology, Detection, screening and diagnosis, 4.2 Evaluation of markers and technologies, Prostate, Neuroendocrine, Genomics, Clinical sciences
Abstract

Management of men with prostate cancer is fraught with uncertainty as physicians and patients balance efficacy with potential toxicity and diminished quality of life. Utilization of genomics as a prognostic biomarker has improved the informed decision-making process by enabling more rationale treatment choices. Recently investigations have begun to determine whether genomic information from tumor transcriptome data can be used to impact clinical decision-making beyond prognosis. Here we discuss the potential of genomics to alter management of a patient who presented with high-risk prostate adenocarcinoma. We suggest that this information help selecting patients for advanced imaging, chemotherapies, or clinical trial.

Published
2016

5. Prospective study to define the clinical utility and benefit of Decipher testing in men following prostatectomy

Author

Marascio, Joseph, Spratt, Daniel E., Zhang, Jingbin, Trabulsi, Edouard J., Le, Tiffany, Sedzorme, Worlanyo Sosu, Beeler, Whitney H., Davicioni, Elai, Dabbas, Bashar, Lin, Daniel W., Gore, John L., Bloom, Matthew, Mann, Mark, Mark, J. Ryan, Calvaresi, Anne, Godwin, James L., McCue, Peter, Hurwitz, Mark D., Kelly, W. Kevin, Lallas, Costas D., Knudsen, Karen E., Gomella, Leonard G., Dicker, Adam P., and Den, Robert B.

Published
2020
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7. Randomized Controlled Trial of Early Zoledronic Acid in Men With Castration-Sensitive Prostate Cancer and Bone Metastases: Results of CALGB 90202 (Alliance)

Author

Smith, Matthew R, Halabi, Susan, Ryan, Charles J, Hussain, Arif, Vogelzang, Nicholas, Stadler, Walter, Hauke, Ralph J, Monk, J Paul, Saylor, Philip, Bhoopalam, Nirmala, Saad, Fred, Sanford, Ben, Kelly, W Kevin, Morris, Michael, and Small, Eric J

Subjects
Clinical Research, Prevention, Clinical Trials and Supportive Activities, Aging, Prostate Cancer, Urologic Diseases, Cancer, Patient Safety, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adenocarcinoma, Aged, Androgen Antagonists, Bone Density Conservation Agents, Bone Neoplasms, Diagnostic Imaging, Diphosphonates, Disease Progression, Humans, Imidazoles, Male, Orchiectomy, Prostatic Neoplasms, Treatment Outcome, Zoledronic Acid, Clinical Sciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeZoledronic acid decreases the risk for skeletal-related events (SREs) in men with castration-resistant prostate cancer and bone metastases but its role earlier in the natural history of the disease is unknown. This phase III study evaluated the efficacy and safety of earlier treatment with zoledronic acid in men with castration-sensitive metastatic prostate cancer.Patients and methodsMen with castration-sensitive prostate cancer and bone metastases whose androgen-deprivation therapy was initiated within 6 months of study entry were randomly assigned in a blinded 1:1 ratio to receive zoledronic acid (4 mg intravenously every 4 weeks) or a placebo. After their disease progressed to castration-resistant status, all patients received open-label treatment with zoledronic acid. The primary end point was time to first SRE, defined as radiation to bone, clinical fracture, spinal cord compression, surgery to bone, or death as a result of prostate cancer. Target accrual was 680 patients. Primary analysis was planned after 470 SREs. The study was discontinued prematurely (645 patients; 299 SREs) after the corporate supporter withdrew study drug supply.ResultsEarly zoledronic acid was not associated with increased time to first SRE. The median time to first SRE was 31.9 months in the zoledronic acid group (95% CI, 24.2 to 40.3) and 29.8 months in the placebo group (95% CI, 25.3 to 37.2; hazard ratio, 0.97; 95% CI, 0 to 1.17; one-sided stratified log-rank P = .39). Overall survival was similar between the groups (hazard ratio, 0.88; 95% CI, 0.70 to 1.12; P = .29). Rates of adverse events were similar between the groups.ConclusionIn men with castration-sensitive prostate cancer and bone metastases, early treatment with zoledronic acid was not associated with lower risk for SREs.

Published
2014

8. Updated Prognostic Model for Predicting Overall Survival in First-Line Chemotherapy for Patients With Metastatic Castration-Resistant Prostate Cancer

Author

Halabi, Susan, Lin, Chen-Yen, Kelly, W Kevin, Fizazi, Karim S, Moul, Judd W, Kaplan, Ellen B, Morris, Michael J, and Small, Eric J

Subjects
Cancer, Urologic Diseases, Clinical Research, Prostate Cancer, Aged, Antibodies, Monoclonal, Humanized, Antineoplastic Combined Chemotherapy Protocols, Bevacizumab, Biomarkers, Tumor, Clinical Trials, Phase III as Topic, Docetaxel, Germany, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Nomograms, Orchiectomy, Predictive Value of Tests, Prednisone, Prognosis, Proportional Hazards Models, Prostate-Specific Antigen, Prostatic Neoplasms, Random Allocation, Reproducibility of Results, Risk Assessment, Risk Factors, Taxoids, Clinical Sciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposePrognostic models for overall survival (OS) for patients with metastatic castration-resistant prostate cancer (mCRPC) are dated and do not reflect significant advances in treatment options available for these patients. This work developed and validated an updated prognostic model to predict OS in patients receiving first-line chemotherapy.MethodsData from a phase III trial of 1,050 patients with mCRPC were used (Cancer and Leukemia Group B CALGB-90401 [Alliance]). The data were randomly split into training and testing sets. A separate phase III trial served as an independent validation set. Adaptive least absolute shrinkage and selection operator selected eight factors prognostic for OS. A predictive score was computed from the regression coefficients and used to classify patients into low- and high-risk groups. The model was assessed for its predictive accuracy using the time-dependent area under the curve (tAUC).ResultsThe model included Eastern Cooperative Oncology Group performance status, disease site, lactate dehydrogenase, opioid analgesic use, albumin, hemoglobin, prostate-specific antigen, and alkaline phosphatase. Median OS values in the high- and low-risk groups, respectively, in the testing set were 17 and 30 months (hazard ratio [HR], 2.2; P < .001); in the validation set they were 14 and 26 months (HR, 2.9; P < .001). The tAUCs were 0.73 (95% CI, 0.70 to 0.73) and 0.76 (95% CI, 0.72 to 0.76) in the testing and validation sets, respectively.ConclusionAn updated prognostic model for OS in patients with mCRPC receiving first-line chemotherapy was developed and validated on an external set. This model can be used to predict OS, as well as to better select patients to participate in trials on the basis of their prognosis.

Published
2014

9. Neoadjuvant Dose-dense Gemcitabine and Cisplatin in Muscle-Invasive Bladder Cancer: Results of a Phase 2 Trial

Author

Anari, Fern, O’Neill, John, Choi, Woonyoung, Chen, David Y.T., Haseebuddin, Mohammed, Kutikov, Alexander, Dulaimi, Essel, Alpaugh, R. Katherine, Devarajan, Karthik, Greenberg, Richard E., Bilusic, Marijo, Wong, Yu-Ning, Viterbo, Rosalia, Hoffman-Censits, Jean H., Lallas, Costas D., Trabulsi, Edouard J., Smaldone, Marc, Geynisman, Daniel M., Zibelman, Matthew, Lin, Jianqing, Kelly, W. Kevin, Uzzo, Robert, McConkey, David, and Plimack, Elizabeth R.

Published
2018
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12. Niraparib in patients with metastatic castration-resistant prostate cancer and DNA repair gene defects (GALAHAD): a multicentre, open-label, phase 2 trial

Author

Smith, Matthew R, primary, Scher, Howard I, additional, Sandhu, Shahneen, additional, Efstathiou, Eleni, additional, Lara, Primo N, additional, Yu, Evan Y, additional, George, Daniel J, additional, Chi, Kim N, additional, Saad, Fred, additional, Ståhl, Olof, additional, Olmos, David, additional, Danila, Daniel C, additional, Mason, Gary E, additional, Espina, Byron M, additional, Zhao, Xin, additional, Urtishak, Karen A, additional, Francis, Peter, additional, Lopez-Gitlitz, Angela, additional, Fizazi, Karim, additional, Parnis, Francis, additional, Joshua, Anthony M., additional, Horvath, Lisa G., additional, Steer, Christopher, additional, Marx, Gavin, additional, Gurney, Howard, additional, Ferguson, Thomas, additional, Van Bruwaene, Siska, additional, Luyten, Daisy, additional, Schatteman, Peter, additional, Lumen, Nicolaas, additional, Dirix, Luc, additional, Goeminne, Jean-Charles, additional, Gil, Thierry, additional, Seront, Emmanuel, additional, Vulsteke, Christof, additional, Kussumoto, Celio, additional, Franke, Fabio A., additional, Martinelli de Oliveira, Fabricio Augusto, additional, Pereira de Santana Gomes, Andrea Juliana, additional, Pinczowski, Hélio, additional, Preto, Daniel D'Almeida, additional, Zucca, Luis Eduardo, additional, Borges, Giuliano Santos, additional, Murad, Andre M., additional, Chi, Kim N., additional, Fradet, Yves, additional, Fleshner, Neil E., additional, Emmenegger, Urban, additional, Brasso, Klaus, additional, Culine, Stephane, additional, Thiery-Vuillemin, Antoine, additional, Joly, Florence, additional, Fléchon, Aude, additional, Hilgers, Werner, additional, Eymard, Jean-Christophe, additional, Borchiellini, Delphine, additional, Barthélémy, Philippe, additional, Berger, Raanan, additional, Leibowitz-Amit, Raya, additional, Mermershtain, Wilmosh, additional, Rouvinov, Keren, additional, Peer, Avivit, additional, Kovel, Svetlana, additional, Sella, Avishay, additional, Lolkema, Martijn P., additional, van den Eertwegh, Alfonsus J.M., additional, Voortman, Johannes, additional, Aarts, Maureen J., additional, Gietema, Jourik A., additional, Kim, Choung-Soo, additional, Choi, Young-Deuk, additional, Chung, Byung-Ha, additional, Gafanov, Rustem A., additional, Kopyltsov, Evgeniy, additional, Usynin, Evgeny A., additional, Carles, Joan, additional, Mellado, Begoña, additional, Maroto, José Pablo, additional, García-Donás, Jesús, additional, Rodríguez Moreno, Juan Francisco, additional, Durán, Ignacio, additional, Pérez-Valderrama, Begoña, additional, Castro, Elena, additional, Méndez-Vidal, María José, additional, Estellés, David Lorente, additional, Sarrió, Regina Gironés, additional, Muñoz-Langa, José, additional, Herranz, Urbano Anido, additional, Puente Vázquez, Javier, additional, Castellanos, Enrique, additional, Hellström, Martin, additional, Widmark, Anders, additional, Lissbrant, Ingela Franck, additional, Jellvert, Åsa, additional, Külich, Cecilia, additional, Blom, René, additional, Chiang, Po-Hui, additional, Kang, Chih-Hsiung, additional, Ou, Yen-Chuan, additional, Wang, Shian-Shiang, additional, Wu, Hsi-Chin, additional, Lu, Yu-Chuan, additional, Attard, Gerhardt, additional, Khoo, Vincent, additional, Bahl, Amit, additional, Kellati, Prasad, additional, Parikh, Omi, additional, Srinivasan, Rajaguru, additional, Lester, Jason F., additional, Staffurth, John N., additional, Cheng, Heather H., additional, Pilié, Patrick G., additional, George, Daniel J., additional, Karsh, Lawrence I., additional, Kelly, W. Kevin, additional, Danila, Daniel C., additional, Sieber, Paul R., additional, Smith, Matthew R., additional, Heath, Elisabeth I., additional, Vaishampayan, Ulka N., additional, Flaig, Thomas W., additional, Emamekhoo, Hamid, additional, Pinski, Jacek K., additional, Kalebasty, Arash Rezazadeh, additional, Maly, Joseph J., additional, and Moon, Helen, additional

Published
2022
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19. Phase I study of AMG 509, a STEAP1 x CD3 T cell-recruiting XmAb 2+1 immune therapy, in patients with metastatic castration-resistant prostate cancer (mCRPC).

Author

Kelly, W. Kevin, primary, Danila, Daniel Costin, additional, Edenfield, William Jeffery, additional, Aggarwal, Rahul Raj, additional, Petrylak, Daniel Peter, additional, Sartor, A. Oliver, additional, Sumey, Christopher Joseph, additional, Dorff, Tanya B., additional, Yu, Evan Y., additional, Adra, Nabil, additional, Waterhouse, David Michael, additional, Armstrong, Andrew J., additional, Horvath, Lisa, additional, Pook, David William, additional, Appleman, Leonard Joseph, additional, Lau, Aubrey, additional, Salvati, Mark, additional, and Kouros-Mehr, Hosein, additional

Published
2020
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20. CD8+ T Cells Impact Rising PSA in Biochemically Relapsed Cancer Patients Using Immunotherapy Targeting Tumor-Associated Antigens

Author

Shore, Neal D., primary, Morrow, Matthew P., additional, McMullan, Trevor, additional, Kraynyak, Kimberly A., additional, Sylvester, Albert, additional, Bhatt, Khamal, additional, Cheung, Jocelyn, additional, Boyer, Jean D., additional, Liu, Li, additional, Sacchetta, Brian, additional, Rosencranz, Samantha, additional, Heath, Elizabeth I., additional, Nordquist, Luke, additional, Cheng, Heather H., additional, Tagawa, Scott T., additional, Appleman, Leonard J., additional, Tutrone, Ronald, additional, Garcia, Jorge A., additional, Whang, Young E., additional, Kelly, W. Kevin, additional, Weiner, David B., additional, Bagarazzi, Mark L., additional, and Skolnik, Jeffrey M., additional

Published
2020
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21. Veterans Affairs Cooperative Studies Program Study #553: Chemotherapy After Prostatectomy for High-risk Prostate Carcinoma: A Phase III Randomized Study

Author

Lin, Daniel W., primary, Shih, Mei-Chiung, additional, Aronson, William, additional, Basler, Joseph, additional, Beer, Tomasz M., additional, Brophy, Mary, additional, Cooperberg, Matthew, additional, Garzotto, Mark, additional, Kelly, W. Kevin, additional, Lee, Kelvin, additional, McGuire, Valerie, additional, Wang, Yajie, additional, Lu, Ying, additional, Markle, Vivian, additional, Nseyo, Unyime, additional, Ringer, Robert, additional, Savage, Stephen J., additional, Sinnott, Patricia, additional, Uchio, Edward, additional, Yang, Claire C., additional, and Montgomery, R. Bruce, additional

Published
2020
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22. Prospective study to define the clinical utility and benefit of Decipher testing in men following prostatectomy

Author

Marascio, Joseph, primary, Spratt, Daniel E., additional, Zhang, Jingbin, additional, Trabulsi, Edouard J., additional, Le, Tiffany, additional, Sedzorme, Worlanyo Sosu, additional, Beeler, Whitney H., additional, Davicioni, Elai, additional, Dabbas, Bashar, additional, Lin, Daniel W., additional, Gore, John L., additional, Bloom, Matthew, additional, Mann, Mark, additional, Mark, J. Ryan, additional, Calvaresi, Anne, additional, Godwin, James L., additional, McCue, Peter, additional, Hurwitz, Mark D., additional, Kelly, W. Kevin, additional, Lallas, Costas D., additional, Knudsen, Karen E., additional, Gomella, Leonard G., additional, Dicker, Adam P., additional, and Den, Robert B., additional

Published
2019
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24. Activity of second-line chemotherapy in docetaxel-refractory hormone-refractory prostate cancer patients: randomized phase 2 study of ixabepilone or mitoxantrone and prednisone

Author

Rosenberg, Jonathan E., Weinberg, Vivian K., Kelly, W. Kevin, Michaelson, Dror, Hussain, Maha H., Wilding, George, Gross, Mitchell, Hutcheon, Douglass, and Small, Eric J.

Subjects
Bristol-Myers Squibb Co. -- Product introduction, Prostate cancer -- Drug therapy, Pharmaceutical industry -- Product introduction, Mitoxantrone hydrochloride -- Dosage and administration, Prednisone -- Dosage and administration, Chemotherapy, Combination -- Research, Survival after airplane accidents, shipwrecks, etc. -- Evaluation, Health
Published
2007

28. A retrospective evaluation of second-line chemotherapy response in hormone-refractory prostate carcinoma: second-line taxane-based therapy after first-line epothilone-B analog ixabepilone (BMS-247550) therapy

Author

Rosenberg, Jonathan E., Galsky, Matthew D., Rohs, Nicholas C., Weinberg, Vivian K., Oh, William K., Kelly, W. Kevin, and Small, Eric J.

Subjects
Prostate cancer -- Care and treatment, Chemotherapy, Combination -- Research, Antimitotic agents -- Research, Antineoplastic agents -- Research, Prostate-specific antigen -- Analysis, Health
Published
2006

30. Society of urologic oncology position statement: redefining the management of hormone-refractory prostate carcinoma

Author

Chang, Sam S., Benson, Mitchell C., Campbell, Steven C., Crook, Juanita, Dreicer, Robert, Evans, Christopher P., Hall, M. Craig, Higano, Celestia, Kelly, W. Kevin, Sartor, Oliver, and Smith, Joseph A., Jr.

Subjects
Prostate cancer -- Research, Prostate cancer -- Care and treatment, Prostate cancer -- Analysis, Prostate cancer -- Prognosis, Hormones -- Research, Hormones -- Care and treatment, Hormones -- Analysis, Health
Published
2005

31. High-dose calcitriol, zoledronate, and dexamethasone for the treatment of progressive prostate carcinoma

Author

Morris, Michael J., Smaletz, Oren, Solit, David, Kelly, W. Kevin, Slovin, Susan, Flombaum, Carlos, Curley, Tracy, Delacruz, Anthony, Schwartz, Lawrence, Fleisher, Martin, Zhu, Andrew, Diani, Meghan, Fallon, Mary, and Scher, Howard I.

Subjects
Prostate cancer -- Care and treatment, Prostate cancer -- Research, Dexamethasone -- Dosage and administration, Dexamethasone -- Research, Calcitriol -- Dosage and administration, Calcitriol -- Research, Health
Published
2004

32. A phase II study of estramustine, docetaxel, and carboplatin with granulocyte-colony-stimulating factor support in patients with hormone-refractory prostate carinoma: cancer and leukemia group b 99813

Author

Oh, William K., Halabi, Susan, Kelly, W. Kevin, Werner, Cary, Godley, Paul A., Vogelzang, Nicholas J., and Small, Eric J.

Subjects
Carboplatin -- Health aspects, Docetaxel -- Health aspects, Nitrogen mustards -- Health aspects, Mortality -- Comparative analysis, Mortality -- United States, Prostate cancer -- Care and treatment, Prostate cancer -- Research, Health
Published
2003

33. Clinical experience with intravenous estramustine phosphate, paclitaxel, and carboplatin in patients with castrate, metastatic prostate adenocarcinoma

Author

Solit, David B., Killanin, Michael Morris, Lord, Slovin, Susan, Curley, Tracy, Schwartz, Lawrence, Larson, Steven, Kattan, Michael W., Hartley-Asp, Beryl, Scher, Howard I., and Kelly, W. Kevin

Subjects
Carboplatin -- Research, Carboplatin -- Analysis, Nitrogen mustards -- Research, Nitrogen mustards -- Analysis, Adenocarcinoma -- Research, Health
Published
2003

38. PD52-03 A MULTICENTER PHASE 1B/2 STUDY OF NEOADJUVANT PEMBROLIZUMAB AND CISPLATIN CHEMOTHERAPY FOR MUSCLE INVASIVE UROTHELIAL CANCER

Author

Kaimakliotis*, Hristos, primary, Albany, Costantine, additional, Hoffman-Censits, Jean, additional, Trabulsi, Edouard, additional, Kelly, W. Kevin, additional, Picus, Joel, additional, Adra, Nabil, additional, Cary, Clint, additional, Koch, Michael, additional, Fleming, Mark, additional, Walling, Radhika, additional, Godwin, J. Luke, additional, Abouassaly, Robert, additional, Cooney, Matthew, additional, Fu, Pingfu, additional, Nelson, Ariel, additional, Xavier, Ginu, additional, Ponsky, Lee, additional, and Hoimes, Christopher, additional

Published
2019
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39. Nuclear Pores Promote Lethal Prostate Cancer by Increasing POM121-Driven E2F1, MYC, and AR Nuclear Import

Author

Rodriguez-Bravo, Veronica, primary, Pippa, Raffaella, additional, Song, Won-Min, additional, Carceles-Cordon, Marc, additional, Dominguez-Andres, Ana, additional, Fujiwara, Naoto, additional, Woo, Jungreem, additional, Koh, Anna P., additional, Ertel, Adam, additional, Lokareddy, Ravi K., additional, Cuesta-Dominguez, Alvaro, additional, Kim, Rosa S., additional, Rodriguez-Fernandez, Irene, additional, Li, Peiyao, additional, Gordon, Ronald, additional, Hirschfield, Hadassa, additional, Prats, Josep M., additional, Reddy, E. Premkumar, additional, Fatatis, Alessandro, additional, Petrylak, Daniel P., additional, Gomella, Leonard, additional, Kelly, W. Kevin, additional, Lowe, Scott W., additional, Knudsen, Karen E., additional, Galsky, Matthew D., additional, Cingolani, Gino, additional, Lujambio, Amaia, additional, Hoshida, Yujin, additional, and Domingo-Domenech, Josep, additional

Published
2018
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41. Can post-operative prostate fossa radiation be omitted in patients with high-risk features using a genomic classifier?

Author

Marascio, Joseph Anthony, primary, Bloom, Matthew, additional, Hurwitz, Mark, additional, Gomella, Leonard G., additional, Lallas, Costas D., additional, Trabulsi, Edouard John, additional, Mann, Mark, additional, Mark, James Ryan, additional, Calvaresi, Anne, additional, Kelly, W. Kevin, additional, Hoffman-Censits, Jean H., additional, Godwin, James Luke, additional, Dicker, Adam, additional, and Den, Robert Benjamin, additional

Published
2018
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42. Potential Impact on Clinical Decision Making via a Genome-Wide Expression Profiling: A Case Report

Author

Kim, Hyun, primary, Alshalalfa, Mohammed, additional, Hoffman-Censits, Jean, additional, Lallas, Costas D., additional, Davicioni, Elai, additional, Lin, Jianqing, additional, Birbe, Ruth, additional, Erho, Nicholas, additional, Lehrer, Jonathan, additional, Ashab, Hussam Al-Deen, additional, Takhar, Mandeep, additional, Olson, Anders, additional, Lam, Lucia L.C., additional, Kelly, W. Kevin, additional, Knudsen, Karen E., additional, Thangavel, Chellappagounder, additional, Seiler, Roland, additional, Feng, Felix Y., additional, Schaeffer, Edward M., additional, Trabulsi, Edouard J., additional, Gomella, Leonard G., additional, Hurwitz, Mark D., additional, Dicker, Adam P., additional, and Den, Robert B., additional

Published
2016
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43. CD8+T Cells Impact Rising PSA in Biochemically Relapsed Cancer Patients Using Immunotherapy Targeting Tumor-Associated Antigens

Author

Shore, Neal D., Morrow, Matthew P., McMullan, Trevor, Kraynyak, Kimberly A., Sylvester, Albert, Bhatt, Khamal, Cheung, Jocelyn, Boyer, Jean D., Liu, Li, Sacchetta, Brian, Rosencranz, Samantha, Heath, Elizabeth I., Nordquist, Luke, Cheng, Heather H., Tagawa, Scott T., Appleman, Leonard J., Tutrone, Ronald, Garcia, Jorge A., Whang, Young E., Kelly, W. Kevin, Weiner, David B., Bagarazzi, Mark L., and Skolnik, Jeffrey M.

Abstract

The management of men with prostate cancer (PCa) with biochemical recurrence following local definitive therapy remains controversial. Early use of androgen deprivation therapy (ADT) leads to significant side effects. Developing an alternative, clinically effective, and well-tolerated therapy remains an unmet clinical need. INO-5150 is a synthetic DNA therapy that includes plasmids encoding for prostate-specific antigen (PSA) and prostate-specific membrane antigen (PSMA), and INO-9012 is a synthetic DNA plasmid encoding for interleukin-12 (IL-12). This phase 1/2, open-label, multi-center study enrolled men with PCa with rising PSA after surgery and/or radiation therapy. Patients were enrolled into one of four treatment arms: arm A, 2 mg of INO-5150; arm B, 8.5 mg of INO-5150; arm C, 2 mg of INO-5150 + 1 mg of INO-9012; and arm D, 8.5 mg of INO-5150 + 1 mg of INO-9012. Patients received study drug with electroporation on day 0 and on weeks 3, 12, and 24, and they were followed for up to 72 weeks. Sixty-two patients were enrolled. Treatment was well tolerated. 81% (50/62) of patients completed all visits. 85% (53/62) remained progression-free at 72 weeks. PSA doubling time (PSADT) was increased when assessed in patients with day 0 PSADT ≤12 months. Immunogenicity was observed in 76% (47/62) of patients by multiple assessments. Analysis indicated that CD38 and perforin co-positive CD8 T cell frequency correlated with attenuated PSA rise (p = 0.05, n = 50).

Published
2020
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45. A PHASE II STUDY OF ESTRAMUSTINE, DOCETAXEL, AND BEVACIZUMAB IN MEN WITH CASTRATE RESISTANT PROSTATE CANCER: RESULTS OF CANCER AND LEUKEMIA GROUP B (CALGB) 90006

Author

Picus, Joel, Halabi, Susan, Kelly, W. Kevin, Vogelzang, Nicholas J., Whang, Young E., Kaplan, Ellen B., Stadler, Walter M., and Small, Eric J.

Subjects
Male, Vascular Endothelial Growth Factor A, Antibodies, Monoclonal, Prostatic Neoplasms, Docetaxel, Adenocarcinoma, Middle Aged, Antibodies, Monoclonal, Humanized, Article, Disease-Free Survival, Bevacizumab, Antineoplastic Combined Chemotherapy Protocols, Estramustine, Humans, Taxoids, Castration, Aged
Abstract

The use of docetaxel prolongs survival for patients with castrate-resistant prostate cancer (CRPC). Inhibition of vascular endothelial growth factor (VEGF) with bevacizumab may further enhance the antitumor effect of docetaxel and estramustine in patients with CRPC.This cooperative group trial enrolled men with CRPC. Patients received oral estramustine 280 mg 3 times daily on Days 1 through 5 of every cycle plus 70 mg/m² docetaxel and 15 mg/kg bevacizumab on Day 2 every 3 weeks. Prostate-specific antigen (PSA) values were monitored every cycle, and imaging studies were obtained every 3 cycles. The primary endpoint was progression-free survival (PFS), and the secondary objectives were safety, PSA decline, measurable disease response, and overall survival.Seventy-nine patients were enrolled; and 77 patients received a median of 8 cycles and were evaluable. A 50% PSA decline was observed in 58 patients (75%). Twenty-three of 39 patients with measurable disease had a partial response (59%). The median PFS was 8 months, and the overall median survival was 24 months. Neutropenia without fever (69%), fatigue (25%), and thrombosis/emboli (9%) were the most common severe toxicities. Twenty-four of 77 patients were removed from protocol treatment because of disease progression, 35 of 77 patients were removed because of a physician or patient decision, and 15 patients were removed secondary to toxicity.The combination of docetaxel, estramustine, and bevacizumab was tolerable but complicated by toxicity. Although the endpoint of PFS did not meet the desired level, encouraging antitumor activity and overall survival were observed. Further phase 3 evaluation of the role of bevacizumab in CRPC is ongoing.

Published
2010

47. Activity of second-line chemotherapy in docetaxel-refractory hormone-refractory prostate cancer patients Presented in part at the American Society of Clinical Oncology Multidisciplinary Prostate Cancer Symposium, February 17???19, 2005, Orlando, Florida; and the American Society of Clinical Oncology Multidisciplinary Prostate Cancer Symposium, February 24???26, 2006.

Author

Department of Medicine, University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, Department of Medicine, University of California at San Francisco, Comprehensive Cancer Center, San Francisco, California ; Fax: (415) 353-7779 ; J. E. Rosenberg has received research funding from Bristol-Myers Squibb. ; University of California at San Francisco, Division of Hematology/Oncology, 1600 Divisadero Street, Box 1711, San Francisco, CA 94115, University of San Francisco, Comprehensive Cancer Center Biostatistics Core, San Francisco, California, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York, Department of Medicine, Harvard Cancer Center, Boston, Massachusetts, Department of Medicine, University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, Department of Medicine, Cedars-Sinai Comprehensive Cancer Institute, Los Angeles, California, Department of Medicine, University of California at San Francisco, Comprehensive Cancer Center, San Francisco, California, Rosenberg, Jonathan E., Weinberg, Vivian K., Kelly, W. Kevin, Michaelson, Dror, Hussain, Maha H., Wilding, George, Gross, Mitchell, Hutcheon, Douglass, Small, Eric J., Department of Medicine, University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, Department of Medicine, University of California at San Francisco, Comprehensive Cancer Center, San Francisco, California ; Fax: (415) 353-7779 ; J. E. Rosenberg has received research funding from Bristol-Myers Squibb. ; University of California at San Francisco, Division of Hematology/Oncology, 1600 Divisadero Street, Box 1711, San Francisco, CA 94115, University of San Francisco, Comprehensive Cancer Center Biostatistics Core, San Francisco, California, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York, Department of Medicine, Harvard Cancer Center, Boston, Massachusetts, Department of Medicine, University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, Department of Medicine, Cedars-Sinai Comprehensive Cancer Institute, Los Angeles, California, Department of Medicine, University of California at San Francisco, Comprehensive Cancer Center, San Francisco, California, Rosenberg, Jonathan E., Weinberg, Vivian K., Kelly, W. Kevin, Michaelson, Dror, Hussain, Maha H., Wilding, George, Gross, Mitchell, Hutcheon, Douglass, and Small, Eric J.

Abstract

BACKGROUND. This randomized, noncomparative, multicenter, clinical trial evaluated ixabepilone or mitoxantrone/prednisone (MP) as second-line chemotherapy for taxane-refractory, hormone-refractory, prostate cancer (HRPC). METHODS. Patients with HRPC that progressed during or within 60 days of cessation of taxane chemotherapy were randomly selected with equal probability to ixabepilone 35 mg/m 2 intravenously every 3 weeks, or mitoxantrone 14 mg/m 2 intravenously every 3 weeks and prednisone 5 mg orally twice daily. Treatment continued until progression or toxicity; crossover was allowed. RESULTS. Forty-one patients were accrued to each arm of the study. The median number of cycles administered for each arm was 3. Median survival from protocol entry was 10.4 months with ixabepilone and 9.8 months with MP. Prostate-specific antigen (PSA) declines of ???50% were observed in 17% of ixabepilone (95% CI, 7-32) and 20% of second-line MP patients (95% CI, 9-35). Partial responses were observed in 1 of 24 ixabepilone and in 2 of 21 MP patients with evaluable measurable disease. Median duration of second-line ixabepilone and MP treatment was 2.2 months and 2.3 months, respectively. For third-line crossover treatment, PSA declines of ???50% were observed in 3 of 27 ixabepilone-treated and 4 of 15 MP-treated patients. Prior taxane response was associated with an increased likelihood of second-line ixabepilone or MP response. Low baseline lactate dehydrogenase and absence of visceral metastases independently predicted improved survival. The most common grade 3/4 toxicity associated with second-line treatment was neutropenia (54% of ixabepilone patients and 63% of MP patients). CONCLUSIONS. Ixabepilone and MP had modest activity as second-line chemotherapy for docetaxel-refractory HRPC. The median survival for the entire cohort treated in this study was 9.8 months. Cancer 2007. ?? 2007 American Cancer Society.

Published
2007

48. A polyvalent vaccine for high-risk prostate patients: 'are more antigens better?'

Author

Slovin, Susan F, Ragupathi, Govind, Fernandez, Celina, Diani, Meghan, Jefferson, Matthew P, Wilton, Andrew, Kelly, W Kevin, Morris, Michael, Solit, David, Clausen, Henrik, Livingston, Philip, Scher, Howard I, Slovin, Susan F, Ragupathi, Govind, Fernandez, Celina, Diani, Meghan, Jefferson, Matthew P, Wilton, Andrew, Kelly, W Kevin, Morris, Michael, Solit, David, Clausen, Henrik, Livingston, Philip, and Scher, Howard I

Abstract

Udgivelsesdato: 2007-Dec, We have shown the immunogenicity and safety of synthetic carbohydrate vaccines when conjugated to the carrier keyhole limpet hemocyanin (KLH) and given with the adjuvant, QS-21, in patients with biochemically relapsed prostate cancer. To determine whether immune response could be further enhanced with stimulation by multiple antigens, a hexavalent vaccine was prepared using previously determined doses and administered in a Phase II setting to 30 high-risk patients. The hexavalent vaccine included GM2, Globo H, Lewis(y), glycosylated MUC-1-32mer and Tn and TF in a clustered formation, conjugated to KLH and mixed with QS-21. Eight vaccinations were administered over 13 months. All 30 patients had significant elevations in antibody titers to at least two of the six antigens; 22 patients had increased reactivity with FACS. These serologic responses were lower than that seen previously in patients treated with the respective monovalent vaccines. The reciprocal median combined IgM and IgG antibody titers with ELISA against MUC1, Tn, TF, globo H and GM2 for these 30 patients were 640, 80, 120, 40 and 0, compared to 1280, 640, 1280, 320 and 160 seen in patients receiving individual monovalent vaccines. This hexavalent vaccine of synthetic "self" antigens broke immunologic tolerance against two or more antigens in all 30 vaccinated patients, was safe, but antibody titers against several of the antigens were lower than those seen in individual monovalent trials. No impact on PSA slope was detected. We address the relevance of the multivalent approach for prostate cancer treatment.

Published
2007

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