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9. Repeat Next-Generation Sequencing Testing on Progression in Men With Metastatic Prostate Cancer Can Identify New Actionable Alterations

Author

Park, Joseph J., Chu, Alec, Li, Jinju, Ali, Alicia, McKay, Rana R., Hwang, Clara, Labriola, Matthew K., Jang, Albert, Kilari, Deepak, Mo, George, Ravindranathan, Deepak, Graham, Laura S., Sokolova, Alexandra, Tripathi, Abhishek, Pilling, Amanda, Jindal, Tanya, Ravindra, Aditya, Cackowski, Frank C., Sweeney, Patrick L., Thapa, Bicky, Amery, Taylor S., Heath, Elisabeth I., Garje, Rohan, Zakharia, Yousef, Koshkin, Vadim S., Bilen, Mehmet A., Schweizer, Michael T., Barata, Pedro C., Dorff, Tanya B., Cieslik, Marcin, Alva, Ajjai S., and Armstrong, Andrew J.

Published
2024
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10. A Phase Ib Study of Atezolizumab with Radium-223 Dichloride in Men with Metastatic Castration-Resistant Prostate CancerPhase Ib Trial of Atezo + Radium-223 in Pts with mCRPC

Author

Fong, Lawrence, Morris, Michael J, Sartor, Oliver, Higano, Celestia S, Pagliaro, Lance, Alva, Ajjai, Appleman, Leonard J, Tan, Winston, Vaishampayan, Ulka, Porcu, Raphaelle, Tayama, Darren, Kadel, Edward E, Yuen, Kobe C, Datye, Asim, Armstrong, Andrew J, and Petrylak, Daniel P

Subjects
Cancer, Clinical Research, Urologic Diseases, Clinical Trials and Supportive Activities, Prostate Cancer, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Humanized, Combined Modality Therapy, Double-Blind Method, Humans, Immune Checkpoint Inhibitors, Male, Middle Aged, Neoplasm Metastasis, Prostatic Neoplasms, Castration-Resistant, Radium, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeMen with metastatic castration-resistant prostate cancer (mCRPC) have limited treatment options after progressing on hormonal therapy and chemotherapy. Here, we evaluate the safety and efficacy of atezolizumab (anti-PD-L1) + radium-223 dichloride (radium-223) in men with mCRPC.Patients and methodsThis phase Ib study evaluated atezolizumab + radium-223 in men with mCRPC and bone and lymph node and/or visceral metastases that progressed after androgen pathway inhibitor treatment. Following safety assessment of concurrent dosing, 45 men were randomized 1:1:1 to concurrent or one of two staggered dosing schedules with either agent introduced one cycle before the other. This was followed by a safety-efficacy expansion cohort (randomized 1:1:1). The primary endpoints were safety and objective response rate (ORR) by RECIST 1.1. Secondary endpoints included radiographic progression-free survival (rPFS), PSA responses, and overall survival (OS).ResultsAs of October 4, 2019, 44 of 45 men were evaluable. All 44 had ≥1 all-cause adverse event (AE); 23 (52.3%) had a grade 3/4 AE. Fifteen (34.1%) grade 3/4 and 3 (6.8%) grade 5 AEs were related to atezolizumab; none were related to radium-223. Confirmed ORR was 6.8% [95% confidence interval (CI), 1.4-18.7], median rPFS was 3.0 months (95% CI, 2.8-4.6), median PSA progression was 3.0 months (95% CI, 2.8-3.3), and median OS was 16.3 months (95% CI, 10.9-22.3).ConclusionsThis phase Ib study demonstrated that atezolizumab + radium-223, regardless of administration schedule, had greater toxicity than either drug alone, with no clear evidence of additional clinical benefit for patients with mCRPC and bone and lymph node and/or visceral metastases.

Published
2021

11. Multi-institutional Analysis of Metastasis-directed Therapy with or Without Androgen Deprivation Therapy in Oligometastatic Castration-sensitive Prostate Cancer

Author

Deek, Matthew P., Sutera, Philip, Jing, Yuezhou, Gao, Robert, Rothman, Emily, Day, Heather, Chang, David, Dirix, Piet, Armstrong, Andrew J., Campbell, Bethany, Lopez Campos, Fernando, Berenguer, Miguel, Ramotar, Matthew, Conde-Moreno, Antonio, Berlin, Alejandro, Bosetti, Davide Giovanni, Corcoran, Niall, Koontz, Bridget, Mercier, Carole, Siva, Shankar, Pryor, David, Ost, Piet, Huynh, Mai Anh, Kroeze, Stephanie, Stish, Bradley, Kiess, Ana, Trock, Bruce, Tran, Phuoc T., Gillessen, Silke, and Sweeney, Christopher

Published
2024
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12. Intensifying Salvage Therapy in Prostate-specific Antigen Recurrent Prostate Cancer After Radical Prostatectomy with Apalutamide, Salvage Radiation, and Docetaxel: The Phase 2 STARTAR Trial

Author

Zhang, Tian, Howard, Lauren, Koontz, Bridget F., Tagawa, Scott T., Nagar, Himanshu, Bitting, Rhonda L., Frizzell, Bart A., Nordquist, Luke, Rasmussen, Julia, Riggan, Colleen, Reyes, Marco, Davies, Catrin, Gray, Steven R., Newman, Carly R., Fernandez, Escarleth, Ramalingam, Sundhar, Harrison, Michael R., George, Daniel J., Wu, Yuan, and Armstrong, Andrew J.

Published
2024
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15. Olaparib plus abiraterone versus placebo plus abiraterone in metastatic castration-resistant prostate cancer (PROpel): final prespecified overall survival results of a randomised, double-blind, phase 3 trial

Author

Saad, Fred, Clarke, Noel W, Oya, Mototsugu, Shore, Neal, Procopio, Giuseppe, Guedes, João Daniel, Arslan, Cagatay, Mehra, Niven, Parnis, Francis, Brown, Emma, Schlürmann, Friederike, Joung, Jae Young, Sugimoto, Mikio, Sartor, Oliver, Liu, Yu-Zhen, Poehlein, Christian, Barker, Laura, del Rosario, Paula Michelle, and Armstrong, Andrew J

Published
2023
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16. The Efficacy of Enzalutamide plus Androgen Deprivation Therapy in Oligometastatic Hormone-sensitive Prostate Cancer: A Post Hoc Analysis of ARCHES

Author

Armstrong, Andrew J., Iguchi, Taro, Azad, Arun A., Villers, Arnauld, Alekseev, Boris, Petrylak, Daniel P., Szmulewitz, Russell Z., Alcaraz, Antonio, Shore, Neal D., Holzbeierlein, Jeffrey, Gomez-Veiga, Francisco, Rosbrook, Brad, Zohren, Fabian, Haas, Gabriel P., Gourgiotti, Georgia, El-Chaar, Nader, and Stenzl, Arnulf

Published
2023
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17. Management of patients with advanced prostate cancer—metastatic and/or castration-resistant prostate cancer: Report of the Advanced Prostate Cancer Consensus Conference (APCCC) 2022

Author

Gillessen, Silke, Bossi, Alberto, Davis, Ian D., de Bono, Johann, Fizazi, Karim, James, Nicholas D., Mottet, Nicolas, Shore, Neal, Small, Eric, Smith, Matthew, Sweeney, Christopher J., Tombal, Bertrand, Antonarakis, Emmanuel S., Aparicio, Ana M., Armstrong, Andrew J., Attard, Gerhardt, Beer, Tomasz M., Beltran, Himisha, Bjartell, Anders, Blanchard, Pierre, Briganti, Alberto, Bristow, Rob G., Bulbul, Muhammad, Caffo, Orazio, Castellano, Daniel, Castro, Elena, Cheng, Heather H., Chi, Kim N., Chowdhury, Simon, Clarke, Caroline S., Clarke, Noel, Daugaard, Gedske, De Santis, Maria, Duran, Ignacio, Eeles, Ross, Efstathiou, Eleni, Efstathiou, Jason, Ekeke, Onyeanunam Ngozi, Evans, Christopher P., Fanti, Stefano, Feng, Felix Y., Fonteyne, Valerie, Fossati, Nicola, Frydenberg, Mark, George, Dan, Gleave, Martin, Gravis, Gwenaelle, Halabi, Susan, Heinrich, Daniel, Herrmann, Ken, Higano, Celestia, Hofman, Michael S., Horvath, Lisa G., Hussain, Maha, Jereczek-Fossa, Barbara A., Jones, Rob, Kanesvaran, Ravindran, Kellokumpu-Lehtinen, Pirkko-Liisa, Khauli, Raja B., Klotz, Laurence, Kramer, Gero, Leibowitz, Raja, Logothetis, Christopher, Mahal, Brandon, Maluf, Fernando, Mateo, Joaquin, Matheson, David, Mehra, Niven, Merseburger, Axel, Morgans, Alicia K., Morris, Michael J., Mrabti, Hind, Mukherji, Deborah, Murphy, Declan G., Murthy, Vedang, Nguyen, Paul L., Oh, William K., Ost, Piet, O’Sullivan, Joe M., Padhani, Anwar R., Pezaro, Carmel J., Poon, Darren M.C., Pritchard, Colin C., Rabah, Danny M., Rathkopf, Dana, Reiter, Robert E., Rubin, Mark A., Ryan, Charles J., Saad, Fred, Sade, Juan Pablo, Sartor, Oliver, Scher, Howard I., Sharifi, Nima, Skoneczna, Iwona, Soule, Howard, Spratt, Daniel E., Srinivas, Sandy, Sternberg, Cora N., Steuber, Thomas, Suzuki, Hiroyoshi, Sydes, Matthew R., Taplin, Mary-Ellen, Tilki, Derya, Türkeri, Levent, Turco, Fabio, Uemura, Hiroji, Uemura, Hirotsugu, Ürün, Yüksel, Vale, Claire L., van Oort, Inge, Vapiwala, Neha, Walz, Jochen, Yamoah, Kosj, Ye, Dingwei, Yu, Evan Y., Zapatero, Almudena, Zilli, Thomas, and Omlin, Aurelius

Published
2023
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18. Survival of African-American and Caucasian men after sipuleucel-T immunotherapy: outcomes from the PROCEED registry

Author

Sartor, Oliver, Armstrong, Andrew J, Ahaghotu, Chiledum, McLeod, David G, Cooperberg, Matthew R, Penson, David F, Kantoff, Philip W, Vogelzang, Nicholas J, Hussain, Arif, Pieczonka, Christopher M, Shore, Neal D, Quinn, David I, Small, Eric J, Heath, Elisabeth I, Tutrone, Ronald F, Schellhammer, Paul F, Harmon, Matthew, Chang, Nancy N, Sheikh, Nadeem A, Brown, Bruce, Freedland, Stephen J, and Higano, Celestia S

Subjects
Cancer, Prostate Cancer, Urologic Diseases, Adult, Black or African American, Aged, Aged, 80 and over, Cancer Vaccines, Disease Progression, Follow-Up Studies, Health Status Disparities, Humans, Infusions, Intravenous, Kallikreins, Kaplan-Meier Estimate, Male, Middle Aged, Prostate-Specific Antigen, Prostatic Neoplasms, Castration-Resistant, Registries, Time Factors, Tissue Extracts, Treatment Outcome, White People, Oncology and Carcinogenesis, Urology & Nephrology
Abstract

PurposeAfrican Americans experience greater prostate cancer risk and mortality than do Caucasians. An analysis of pooled phase III data suggested differences in overall survival (OS) between African American and Caucasian men receiving sipuleucel-T. We explored this in PROCEED (NCT01306890), an FDA-requested registry in over 1900 patients with metastatic castration-resistant prostate cancer (mCRPC) treated with sipuleucel-T.Patients and methodsOS for patients who received ≥1 sipuleucel-T infusion was compared between African American and Caucasian men using an all patient set and a baseline prostate-specific antigen (PSA)-matched set (two Caucasians to every one African American with baseline PSAs within 10% of each other). Univariable and multivariable analyses were conducted. Survival data were examined using Kaplan-Meier and Cox proportional hazard methodologies.ResultsMedian follow-up was 46.6 months. Overall survival differed between African American and Caucasian men with hazard ratios (HR) of 0.81 (95% confidence interval [CI]: 0.68-0.97, P = 0.03) in the all patient set and 0.70 (95% CI: 0.57-0.86, P

Published
2020

19. Targeting cellular heterogeneity with CXCR2 blockade for the treatment of therapy-resistant prostate cancer

Author

Li, Yanjing, He, Yiping, Butler, William, Xu, Lingfan, Chang, Yan, Lei, Kefeng, Zhang, Hong, Zhou, Yinglu, Gao, Allen C, Zhang, Qingfu, Taylor, Daniel G, Cheng, Donghui, Farber-Katz, Suzette, Karam, Rachid, Landrith, Tyler, Li, Bing, Wu, Sitao, Hsuan, Vickie, Yang, Qing, Hu, Hailiang, Chen, Xufeng, Flowers, Melissa, McCall, Shannon J, Lee, John K, Smith, Bryan A, Park, Jung Wook, Goldstein, Andrew S, Witte, Owen N, Wang, Qianben, Rettig, Matthew B, Armstrong, Andrew J, Cheng, Qing, and Huang, Jiaoti

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Immunology, Cancer, Urologic Diseases, Aging, Prostate Cancer, 5.1 Pharmaceuticals, Development of treatments and therapeutic interventions, Aetiology, 2.1 Biological and endogenous factors, Animals, Biomarkers, Tumor, Cell Line, Tumor, Cell Membrane, Disease Progression, Drug Resistance, Neoplasm, Humans, Male, Mice, Nude, Molecular Targeted Therapy, Neoplasm Grading, Neoplastic Stem Cells, Neovascularization, Pathologic, Neuroendocrine Tumors, Neurosecretory Systems, Phenotype, Prostatic Neoplasms, Receptors, Interleukin-8B, Signal Transduction, Tumor Microenvironment, Biological Sciences, Medical and Health Sciences, Medical biotechnology, Biomedical engineering
Abstract

Hormonal therapy targeting androgen receptor (AR) is initially effective to treat prostate cancer (PCa), but it eventually fails. It has been hypothesized that cellular heterogeneity of PCa, consisting of AR+ luminal tumor cells and AR- neuroendocrine (NE) tumor cells, may contribute to therapy failure. Here, we describe the successful purification of NE cells from primary fresh human prostate adenocarcinoma based on the cell surface receptor C-X-C motif chemokine receptor 2 (CXCR2). Functional studies revealed CXCR2 to be a driver of the NE phenotype, including loss of AR expression, lineage plasticity, and resistance to hormonal therapy. CXCR2-driven NE cells were critical for the tumor microenvironment by providing a survival niche for the AR+ luminal cells. We demonstrate that the combination of CXCR2 inhibition and AR targeting is an effective treatment strategy in mouse xenograft models. Such a strategy has the potential to overcome therapy resistance caused by tumor cell heterogeneity.

Published
2019

20. Real‐world outcomes of sipuleucel‐T treatment in PROCEED, a prospective registry of men with metastatic castration‐resistant prostate cancer

Author

Higano, Celestia S, Armstrong, Andrew J, Sartor, A Oliver, Vogelzang, Nicholas J, Kantoff, Philip W, McLeod, David G, Pieczonka, Christopher M, Penson, David F, Shore, Neal D, Vacirca, Jeffrey, Concepcion, Raoul S, Tutrone, Ronald F, Nordquist, Luke T, Quinn, David I, Kassabian, Vahan, Scholz, Mark C, Harmon, Matt, Tyler, Robert C, Chang, Nancy N, Tang, Hong, and Cooperberg, Matthew R

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Cancer, Prostate Cancer, Urologic Diseases, Aging, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Aged, Humans, Male, Neoplasm Metastasis, Prospective Studies, Prostatic Neoplasms, Castration-Resistant, Registries, Tissue Extracts, immunotherapy, overall survival, prostate cancer, safety, Public Health and Health Services, Oncology & Carcinogenesis, Oncology and carcinogenesis, Public health
Abstract

BackgroundThe large registry, PROVENGE Registry for the Observation, Collection, and Evaluation of Experience Data (PROCEED)(NCT01306890), evaluated sipuleucel-T immunotherapy for asymptomatic/minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC).MethodsPROCEED enrolled patients with mCRPC receiving 3 biweekly sipuleucel-T infusions. Assessments included overall survival (OS), serious adverse events (SAEs), cerebrovascular events (CVEs), and anticancer interventions (ACIs). Follow-up was for ≥3 years or until death or study withdrawal.ResultsIn 2011-2017, 1976 patients were followed for 46.6 months (median). The median age was 72 years, and the baseline median prostate-specific antigen level was 15.0 ng/mL; 86.7% were white, and 11.6% were African American. Among the patients, 1902 had 1 or more sipuleucel-T infusions. The median OS was 30.7 months (95% confidence interval [CI], 28.6-32.2 months). Known prognostic factors were independently associated with OS in a multivariable analysis. Among the 1255 patients who died, 964 (76.8%) died of prostate cancer (PC) progression. The median time from the first infusion to PC death was 42.7 months (95% CI, 39.4-46.2 months). The incidence of sipuleucel-T-related SAEs was 3.9%. The incidence of CVEs was 2.8%, and the rate per 100 person-years was 1.2 (95% CI, 0.9-1.6). The CVE incidence among 11,972 patients with mCRPC from the Surveillance, Epidemiology, and End Results-Medicare database was 2.8%; the rate per 100 person-years was 1.5 (95% CI, 1.4-1.7). One or more ACIs (abiraterone, enzalutamide, docetaxel, cabazitaxel, or radium 223) were received by 77.1% of the patients after sipuleucel-T; 32.5% and 17.4% of the patients experienced 1- and 2-year treatment-free intervals, respectively.ConclusionsPROCEED provides contemporary survival data for sipuleucel-T-treated men in a real-world setting of new life-prolonging agents, which will be useful in discussing treatment options with patients and in powering future trials with sipuleucel-T. The safety and tolerability of sipuleucel-T in PROCEED were consistent with previous findings.

Published
2019

21. Management of Patients with Advanced Prostate Cancer. Part I: Intermediate-/High-risk and Locally Advanced Disease, Biochemical Relapse, and Side Effects of Hormonal Treatment: Report of the Advanced Prostate Cancer Consensus Conference 2022

Author

Gillessen, Silke, Bossi, Alberto, Davis, Ian D., de Bono, Johann, Fizazi, Karim, James, Nicholas D., Mottet, Nicolas, Shore, Neal, Small, Eric, Smith, Matthew, Sweeney, Christopher, Tombal, Bertrand, Antonarakis, Emmanuel S., Aparicio, Ana M., Armstrong, Andrew J., Attard, Gerhardt, Beer, Tomasz M., Beltran, Himisha, Bjartell, Anders, Blanchard, Pierre, Briganti, Alberto, Bristow, Rob G., Bulbul, Muhammad, Caffo, Orazio, Castellano, Daniel, Castro, Elena, Cheng, Heather H., Chi, Kim N., Chowdhury, Simon, Clarke, Caroline S., Clarke, Noel, Daugaard, Gedske, De Santis, Maria, Duran, Ignacio, Eeles, Ros, Efstathiou, Eleni, Efstathiou, Jason, Ngozi Ekeke, Onyeanunam, Evans, Christopher P., Fanti, Stefano, Feng, Felix Y., Fonteyne, Valerie, Fossati, Nicola, Frydenberg, Mark, George, Daniel, Gleave, Martin, Gravis, Gwenaelle, Halabi, Susan, Heinrich, Daniel, Herrmann, Ken, Higano, Celestia, Hofman, Michael S., Horvath, Lisa G., Hussain, Maha, Jereczek-Fossa, Barbara Alicja, Jones, Robert, Kanesvaran, Ravindran, Kellokumpu-Lehtinen, Pirkko-Liisa, Khauli, Raja B., Klotz, Laurence, Kramer, Gero, Leibowitz, Raya, Logothetis, Christopher J., Mahal, Brandon A., Maluf, Fernando, Mateo, Joaquin, Matheson, David, Mehra, Niven, Merseburger, Axel, Morgans, Alicia K., Morris, Michael J., Mrabti, Hind, Mukherji, Deborah, Murphy, Declan G., Murthy, Vedang, Nguyen, Paul L., Oh, William K., Ost, Piet, O'Sullivan, Joe M., Padhani, Anwar R., Pezaro, Carmel, Poon, Darren M.C., Pritchard, Colin C., Rabah, Danny M., Rathkopf, Dana, Reiter, Robert E., Rubin, Mark. A., Ryan, Charles J., Saad, Fred, Pablo Sade, Juan, Sartor, Oliver A., Scher, Howard I., Sharifi, Nima, Skoneczna, Iwona, Soule, Howard, Spratt, Daniel E., Srinivas, Sandy, Sternberg, Cora N., Steuber, Thomas, Suzuki, Hiroyoshi, Sydes, Matthew R., Taplin, Mary-Ellen, Tilki, Derya, Türkeri, Levent, Turco, Fabio, Uemura, Hiroji, Uemura, Hirotsugu, Ürün, Yüksel, Vale, Claire L., van Oort, Inge, Vapiwala, Neha, Walz, Jochen, Yamoah, Kosj, Ye, Dingwei, Yu, Evan Y., Zapatero, Almudena, Zilli, Thomas, and Omlin, Aurelius

Published
2023
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22. Characterization of a castrate-resistant prostate cancer xenograft derived from a patient of West African ancestry

Author

Patierno, Brendon M., Foo, Wen-Chi, Allen, Tyler, Somarelli, Jason A., Ware, Kathryn E., Gupta, Santosh, Wise, Sandra, Wise, Sr., John P., Qin, Xiaodi, Zhang, Dadong, Xu, Lingfan, Li, Yanjing, Chen, Xufeng, Inman, Brant A., McCall, Shannon J., Huang, Jiaoti, Kittles, Rick A., Owzar, Kouros, Gregory, Simon, Armstrong, Andrew J., George, Daniel J., Patierno, Steven R., Hsu, David S., and Freedman, Jennifer A.

Published
2022
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24. Phase III, double-blind, placebo-controlled, 2-cohort, randomized study of saruparib (AZD5305) in combination with new hormonal agents in patients with metastatic castration-sensitive prostate cancer with and without homologous recombination repair mutation (EvoPAR-Prostate01).

Author

Chi, Kim N., primary, Agarwal, Neeraj, additional, Armstrong, Andrew J., additional, Hellmis, Eva, additional, Schlürmann, Friederike, additional, Sugimoto, Mikio, additional, Ürün, Yüksel, additional, Xing, Nianzeng, additional, Aregay, Mehreteab, additional, Lima, Julianne, additional, Meulendijks, Didier, additional, and Azad, Arun, additional

Published
2024
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25. Association of tumor genetics with outcomes in patients (pts) with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) treated with 177Lu-PSMA-617.

Author

Panian, Justine, primary, Henderson, Nicholas, additional, Barata, Pedro C., additional, Bilen, Mehmet Asim, additional, Graham, Laura, additional, Heath, Elisabeth I., additional, Herchenhorn, Daniel, additional, Hwang, Clara, additional, Kilari, Deepak, additional, Koshkin, Vadim S, additional, Nauseef, Jones T., additional, Sokolova, Alexandra, additional, Zakharia, Yousef, additional, Schweizer, Michael Thomas, additional, Dorff, Tanya B., additional, Armstrong, Andrew J., additional, Alva, Ajjai Shivaram, additional, and McKay, Rana R., additional

Published
2024
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26. Association between prostate-specific antigen (PSA) level <0.2 ng/mL and risk of radiological progression in patients (pts) with nonmetastatic castration-resistant prostate cancer (nmCRPC): Follow-up analysis of ARAMIS.

Author

Morgans, Alicia K., primary, Sweeney, Christopher, additional, Wallis, Christopher J.D., additional, Halabi, Susan, additional, Armstrong, Andrew J., additional, Adorjan, Patrick, additional, Ghadessi, Mercedeh, additional, Verholen, Frank, additional, and Grimm, Marc-Oliver, additional

Published
2024
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27. Overall survival from PANTHER: A multicenter trial of apalutamide, abiraterone acetate plus prednisone in Black and White patients with metastatic castration-resistant prostate cancer (mCRPC).

Author

George, Daniel J., primary, Halabi, Susan, additional, Fleming, Mark T., additional, Heath, Elisabeth I., additional, Tutrone, Ronald, additional, Sutton, Linda, additional, Whang, Young E., additional, Lewis, Brian E., additional, Humeniuk, Michael Sandon, additional, Harrison, Michael Roger, additional, Kephart, Julie, additional, Hurrelbrink, Julia, additional, Rasmussen, Julia, additional, Shobe, Kellie, additional, Anand, Monika, additional, Reyes-Martinez, Marco, additional, Howard, Lauren, additional, Patierno, Steven R., additional, Freedman, Jennifer A, additional, and Armstrong, Andrew J., additional

Published
2024
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28. PD01-03 THIRD INTERIM ANALYSIS (IA3) OF THE DAROLUTAMIDE OBSERVATIONAL (DAROL) STUDY IN PATIENTS WITH NONMETASTATIC CASTRATION-RESISTANT PROSTATE CANCER (NMCRPC)

Author

Gotto, Geoffrey, primary, Suzuki, Hiroyoshi, additional, Luz, Murilo, additional, Briganti, Alberto, additional, Yu, Evan Y., additional, Pieczonka, Christopher, additional, Murphy, Declan, additional, Malone, Ryan, additional, Hamilton, Joelle, additional, Chan, Jonathan E., additional, Sieber, Paul, additional, Given, Robert W., additional, Adorjan, Patrick, additional, Ghadessi, Mercedeh, additional, Verholen, Frank, additional, and Armstrong, Andrew J., additional

Published
2024
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30. Biomarkers of immunotherapy in urothelial and renal cell carcinoma: PD-L1, tumor mutational burden, and beyond

Author

Zhu, Jason, Armstrong, Andrew J, Friedlander, Terence W, Kim, Won, Pal, Sumanta K, George, Daniel J, and Zhang, Tian

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Immunology, Cancer, Kidney Disease, 4.1 Discovery and preclinical testing of markers and technologies, Detection, screening and diagnosis, 4.2 Evaluation of markers and technologies, Biomarkers, Tumor, Carcinoma, Renal Cell, Humans, Immunotherapy, Kidney Neoplasms, Mutation, Programmed Cell Death 1 Receptor, Tumor Burden, Urinary Bladder Neoplasms, PD-L1, Biomarkers, Immune checkpoint inhibition, Urothelial carcinoma, Renal cell carcinoma, Oncology and carcinogenesis
Abstract

Immune checkpoint inhibitors targeting the PD-1 pathway have greatly changed clinical management of metastatic urothelial carcinoma and metastatic renal cell carcinoma. However, response rates are low, and biomarkers are needed to predict for treatment response. Immunohistochemical quantification of PD-L1 was developed as a promising biomarker in early clinical trials, but many shortcomings of the four different assays (different antibodies, disparate cellular populations, and different thresholds of positivity) have limited its clinical utility. Further limitations include the use of archival specimens to measure this dynamic biomarker. Indeed, until PD-L1 testing is standardized and can consistently predict treatment outcome, the currently available PD-L1 assays are not clinically useful in urothelial and renal cell carcinoma. Other more promising biomarkers include tumor mutational burden, profiles of tumor infiltrating lymphocytes, molecular subtypes, and PD-L2. Potentially, a composite biomarker may be best but will need prospective testing to validate such a biomarker.

Published
2018

31. Bimodal liquid biopsy for cancer immunotherapy based on peptide engineering and nanoscale analysis

Author

Bu, Jiyoon, Jeong, Woo-jin, Jafari, Roya, Kubiatowicz, Luke J., Nair, Ashita, Poellmann, Michael J., Hong, Rachel S., Liu, Elizabeth W., Owen, Randall H., Rawding, Piper A., Hopkins, Caroline M., Kim, DaWon, George, Daniel J., Armstrong, Andrew J., Král, Petr, Wang, Andrew Z., Bruce, Justine, Zhang, Tian, Kimple, Randall J., and Hong, Seungpyo

Published
2022
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33. A randomized controlled trial comparing changes in fitness with or without supervised exercise in patients initiated on enzalutamide and androgen deprivation therapy for non-metastatic castration-sensitive prostate cancer (EXTEND)

Author

Harrison, Michael R., Davis, Paul G., Khouri, Michel G., Bartlett, David B., Gupta, Rajan T., Armstrong, Andrew J., McNamara, Megan A., Zhang, Tian, Anand, Monika, Onyenwoke, Kelly, Edwardson, Sara, Craig, Danielle, Michalski, Meghan, Wu, Yuan, Oyekunle, Taofik, Coyne, Brian, Coburn, Aubrie, Jones, Lee W., and George, Daniel J.

Published
2022
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36. DNA-Damaging Therapies in Patients With Prostate Cancer and Pathogenic Alterations in Homologous Recombination Repair Genes.

Author

Graham, Laura S., Henderson, Nicholas C., Kellezi, Olesia, Hwang, Clara, Barata, Pedro C., Bilen, Mehmet A., Kilari, Deepak, Pierro, Michael, Thapa, Bicky, Tripathi, Abhishek, Mo, George, Labriola, Matthew, Park, Joseph J., Rothstein, Shoshana, Garje, Rohan, Koshkin, Vadim S., Patel, Vaibhav G., Dorff, Tanya, Armstrong, Andrew J., and McKay, Rana R.

Subjects
HOMOLOGOUS recombination, PROSTATE cancer patients, CYCLIN-dependent kinases, CHECKPOINT kinase 1, OVERALL survival
Abstract

PURPOSE: Outcomes data for DNA-damaging therapeutics for men with prostate cancer (PC) and non- BRCA1/2 homologous recombination repair (HRR) mutations are limited. We evaluated outcomes by HRR alteration in men with PC treated with poly(ADP-ribose)polymerase inhibitors (PARPi) and/or platinum chemotherapy. METHODS: Retrospective data from the PROMISE consortium were used. Clinical outcomes differences were assessed between patients with BRCA1 / 2 mutations (cohort A) and those with HRR mutations without direct BRCA complex interaction (cohort B: ATM , CDK12 , CHEK1 , CHEK2 , and FANCL). Outcomes in patients with HRR mutations with direct BRCA complex interaction were also explored (cohort C: RAD51B/C/D , RAD54L2 , BARD1 , GEN1 , PALB2 , FANCA , and BRIP1). RESULTS: One hundred and forty-six patients received PARPi (cohort A: 94, cohort B: 45, cohort C: 7) and 104 received platinum chemotherapy (cohort A: 48, cohort B: 44, cohort C: 10). PSA50 response rate to PARPi was higher in cohort A (61%) than cohort B (5%), P <.001. Median clinical/radiographic progression-free survival (crPFS) with PARPi in cohort A was significantly longer than in cohort B: 15.9 versus 8.7 months, P =.005. PSA50 response rate to platinum therapy was higher in cohort A (62%) than in cohort B (32%), P =.024, although crPFS was not significantly different. PSA50 response rate to PARPi and platinum was 40% and 32%, respectively, in cohort C. In multivariable analysis, cohort A had significantly improved overall survival and crPFS compared with cohort B with PARPi but not platinum chemotherapy. CONCLUSION: Patients with BRCA1/2 -mutated PC had significantly improved outcomes to PARPi but not platinum chemotherapy compared with those with HRR mutations without direct BRCA complex interaction. [ABSTRACT FROM AUTHOR]

Published
2024
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37. RB1-deficient prostate tumor growth and metastasis are vulnerable to ferroptosis induction via the E2F/ACSL4 axis

Author

Wang, Mu-En, Chen, Jiaqi, Lu, Yi, Bawcom, Alyssa R., Wu, Jinjin, Ou, Jianhong, Asara, John M., Armstrong, Andrew J., Wang, Qianben, Li, Lei, Wang, Yuzhuo, Huang, Jiaoti, and Chen, Ming

Subjects
Prostate cancer -- Genetic aspects -- Development and progression, Tumor suppressor genes -- Health aspects -- Physiological aspects, Acetyl coenzyme A synthetase -- Physiological aspects -- Health aspects, Apoptosis -- Genetic aspects -- Health aspects, Transcription factors -- Physiological aspects -- Health aspects, Health care industry
Abstract

Inactivation of the RB1 tumor suppressor gene is common in several types of therapy-resistant cancers, including metastatic castration-resistant prostate cancer, and predicts poor clinical outcomes. Effective therapeutic strategies against RBI-deficient cancers remain elusive. Here, we showed that RB1 loss/E2F activation sensitized cancer cells to ferroptosis, a form of regulated cell death driven by iron-dependent lipid peroxidation, by upregulating expression of ACSL4 and enriching ACSL4-dependent arachidonic acid-containing phospholipids, which are key components of ferroptosis execution. ACSL4 appeared to be a direct E2F target gene and was critical to RB1 loss-induced sensitization to ferroptosis. Importantly, using cell line-derived xenografts and genetically engineered tumor models, we demonstrated that induction of ferroptosis in vivo by JKE-1674, a highly selective and stable GPX4 inhibitor, blocked RBI-deficient prostate tumor growth and metastasis and led to improved survival of the mice. Thus, our findings uncover an RB/E2F/ACSL4 molecular axis that governs ferroptosis and also suggest a promising approach for the treatment of RBI-deficient malignancies., Introduction Mutations in the retinoblastoma tumor suppressor gene, RB1, are common in a wide spectrum of pediatric and adult cancers, including retinoblastoma, sarcoma, small cell lung and prostate cancers, and [...]

Published
2023
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38. Randomized Phase 2 Trial of Abiraterone Acetate Plus Prednisone, Degarelix, or the Combination in Men with Biochemically Recurrent Prostate Cancer After Radical Prostatectomy

Author

Autio, Karen A., Antonarakis, Emmanuel S., Mayer, Tina M., Shevrin, Daniel H., Stein, Mark N., Vaishampayan, Ulka N., Morris, Michael J., Slovin, Susan F., Heath, Elisabeth I., Tagawa, Scott T., Rathkopf, Dana E., Milowsky, Matthew I., Harrison, Michael R., Beer, Tomasz M., Balar, Arjun V., Armstrong, Andrew J., George, Daniel J., Paller, Channing J., Apollo, Arlyn, Danila, Daniel C., Graff, Julie N., Nordquist, Luke, Dayan Cohn, Erica S., Tse, Kin, Schreiber, Nicole A., Heller, Glenn, and Scher, Howard I.

Published
2021
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39. Phase II Trial of Enzalutamide and Androgen Deprivation Therapy with Salvage Radiation in Men with High-risk Prostate-specific Antigen Recurrent Prostate Cancer: The STREAM Trial

Author

Bitting, Rhonda L., Healy, Patrick, George, Daniel J., Anand, Monika, Kim, Sung, Mayer, Tina, Winters, Carol, Riggan, Colleen, Rasmussen, Julia, Wilder, Rhonda, Stein, Mark, Frizzell, Bart, Harrison, Michael R., Zhang, Tian, Lee, William R., Wu, Yuan, Koontz, Bridget F., and Armstrong, Andrew J.

Published
2021
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40. Expert Perspectives on Controversies in Castration-Sensitive Prostate Cancer Management: Narrative Review and Report of the First US Prostate Cancer Conference Part 1

Author

Crawford, E. David, primary, Bryce, Alan H., additional, Hussain, Maha H., additional, Agarwal, Neeraj, additional, Beltran, Himisha, additional, Cooperberg, Matthew R., additional, Petrylak, Daniel P., additional, Shore, Neal, additional, Spratt, Daniel E., additional, Tagawa, Scott T., additional, Antonarakis, Emmanuel S., additional, Aparicio, Ana M., additional, Armstrong, Andrew J., additional, Boike, Thomas P., additional, Calais, Jeremie, additional, Carducci, Michael A., additional, Chapin, Brian F., additional, Cookson, Michael S., additional, Davis, John W., additional, Dorff, Tanya, additional, Eggener, Scott E., additional, Feng, Felix Y., additional, Gleave, Martin, additional, Higano, Celestia, additional, Iagaru, Andrei, additional, Morgans, Alicia K., additional, Morris, Michael, additional, Murray, Katie S., additional, Poage, Wendy, additional, Rettig, Matthew B., additional, Sartor, Oliver, additional, Scher, Howard I., additional, Sieber, Paul, additional, Small, Eric, additional, Srinivas, Sandy, additional, Yu, Evan Y., additional, Zhang, Tian, additional, and Koo, Phillip J., additional

Published
2024
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41. Expert Perspectives on Controversies in Metastatic Castration-Resistant Prostate Cancer Management: Narrative Review and Report of the First US Prostate Cancer Conference Part 2

Author

Bryce, Alan H., primary, Crawford, E. David, additional, Agarwal, Neeraj, additional, Hussain, Maha H., additional, Beltran, Himisha, additional, Cooperberg, Matthew R., additional, Petrylak, Daniel P., additional, Shore, Neal, additional, Spratt, Daniel E., additional, Tagawa, Scott T., additional, Antonarakis, Emmanuel S., additional, Aparicio, Ana M., additional, Armstrong, Andrew J., additional, Boike, Thomas P., additional, Calais, Jeremie, additional, Carducci, Michael A., additional, Chapin, Brian F., additional, Cookson, Michael S., additional, Davis, John W., additional, Dorff, Tanya, additional, Eggener, Scott E., additional, Feng, Felix Y., additional, Gleave, Martin, additional, Higano, Celestia, additional, Iagaru, Andrei, additional, Morgans, Alicia K., additional, Morris, Michael, additional, Murray, Katie S., additional, Poage, Wendy, additional, Rettig, Matthew B., additional, Sartor, Oliver, additional, Scher, Howard I., additional, Sieber, Paul, additional, Small, Eric, additional, Srinivas, Sandy, additional, Yu, Evan Y., additional, Zhang, Tian, additional, and Koo, Phillip J., additional

Published
2024
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42. Supplementary Figure S1 from The Impact of Circulating Tumor Cell HOXB13 RNA Detection in Men with Metastatic Castration-Resistant Prostate Cancer (mCRPC) Treated with Abiraterone or Enzalutamide

Author

Halabi, Susan, primary, Guo, Siyuan, primary, Park, Joseph J., primary, Nanus, David M., primary, George, Daniel J., primary, Antonarakis, Emmanuel S., primary, Danila, Daniel Costin, primary, Szmulewitz, Russell Zelig, primary, McDonnell, Donald P., primary, Norris, John D., primary, Lu, Changxue, primary, Luo, Jun, primary, and Armstrong, Andrew J., primary

Published
2024
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43. Supplementary Table S4 from The Impact of Circulating Tumor Cell HOXB13 RNA Detection in Men with Metastatic Castration-Resistant Prostate Cancer (mCRPC) Treated with Abiraterone or Enzalutamide

Author

Halabi, Susan, primary, Guo, Siyuan, primary, Park, Joseph J., primary, Nanus, David M., primary, George, Daniel J., primary, Antonarakis, Emmanuel S., primary, Danila, Daniel Costin, primary, Szmulewitz, Russell Zelig, primary, McDonnell, Donald P., primary, Norris, John D., primary, Lu, Changxue, primary, Luo, Jun, primary, and Armstrong, Andrew J., primary

Published
2024
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49. Enzalutamide in Men with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer: Extended Analysis of the Phase 3 PREVAIL Study

Author

Beer, Tomasz M, Armstrong, Andrew J, Rathkopf, Dana, Loriot, Yohann, Sternberg, Cora N, Higano, Celestia S, Iversen, Peter, Evans, Christopher P, Kim, Choung-Soo, Kimura, Go, Miller, Kurt, Saad, Fred, Bjartell, Anders S, Borre, Michael, Mulders, Peter, Tammela, Teuvo L, Parli, Teresa, Sari, Suha, van Os, Steve, Theeuwes, Ad, and Tombal, Bertrand

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Aging, Clinical Trials and Supportive Activities, Cancer, Prostate Cancer, Clinical Research, Urologic Diseases, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Antineoplastic Agents, Benzamides, Humans, Male, Nitriles, Phenylthiohydantoin, Prostatic Neoplasms, Castration-Resistant, Survival Analysis, Androgen receptor signaling inhibitor, Enzalutamide, Metastatic castration-resistant prostate cancer, Overall survival, Radiographic progression-free survival, Urology & Nephrology, Clinical sciences
Abstract

Enzalutamide significantly improved radiographic progression-free survival (rPFS) and overall survival (OS) among men with chemotherapy-naïve metastatic castration-resistant prostate cancer at the prespecified interim analysis of PREVAIL, a phase 3, double-blind, randomized study. We evaluated the longer-term efficacy and safety of enzalutamide up to the prespecified number of deaths in the final analysis, which included an additional 20 mo of follow-up for investigator-assessed rPFS, 9 mo of follow-up for OS, and 4 mo of follow-up for safety. Enzalutamide reduced the risk of radiographic progression or death by 68% (hazard ratio [HR] 0.32, 95% confidence interval [CI] 0.28-0.37; p

Published
2017

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