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1. Abiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer

Author

Fizazi, Karim, Tran, Namphuong, Fein, Luis, Matsubara, Nobuaki, Rodriguez Antolin, Alfredo, Alekseev, Boris Y., Özgã¼roglu, Mustafa, Dingwei, Ye, Feyerabend, Susan, Protheroe, Andrew, De Porre, Peter, Kheoh, Thian, Park, Youn C., Todd, Mary B., Chi, Korbenfeld E, Kim N., Metrebian, S, Kaen, L, Staneloni, E, Batagelj, E, Tan, H, Hovey, E, Woo, H, Frydenberg, M, Chua, W, D’Hondt, L, Evaraert, E, Verschaeve, V, Wynendaele, W, Schrijvers, D, Waltregny, D, Whenham, N, Demey, W, Franke, F, Panhoca, R, Damião, R, Zucca, L, Da Rosa, V, Reis, R, Scalabrini, A, Nahas, W, Girotto, G, Nogueira, A, Gomes, A, Coradazzi, A, Kurteva, G, Siemens, R, Gingerich, J, Fleshner, N, Fradet, Y, Morgan, S, North, S, Saad, F, Shayegan, B, Zalewski, P, Pinochet, R, Orellana, N, Ding, Q, Ye, Z, Xie, L, Du, C, Chen, Z, Huang, Y, Sun, Z, Li, H, Jin, J, Li, C, Wan, B, Tian, Y, Zhou, F, Xie, K, Yao, X, Qiu, M, Zou, Q, Na, Y, Sun, Y, Xue, B, Ma, L, Martinez, C, Salazar, M, Larios, C, Solano, S, Pavlik, I, Brodak, M, Hora, M, Büchler, T, Borre, M, Johansen, J, Mejlholm, I, Poulsen, M, Wittendorf, He, Tammela, T, Vaarala, M, Theodore, C, Staudacher, L, Villers, A, Laplaige, P, Suttman, H, Steuber, T, Natale, S, Jones, R, Tran, A, Mazhar, D, Mills, J, Nyirady, P, Salamon, C, Torzsok, F, Feher, J, Géczi, L, Lakatos, A, Keizman, D, Sella, A, Frank, S, Peer, A, Rosenbaum, E, Berger, R, Mermershtain, W, Carteni, G, Tonini, G, De Giorgi, U, Facchini, G, Berruti, Alfredo, Bracarda, S, Basso, U, Galli, L, Tortora, G, Alietta, M, Fukasawa, S, Suzuki, H, Hasumi, H, Tsuchiya, T, Uemura, H, Kanayama, H, Hashine, K, Sato, F, Matsumoto, H, Oya, M, Lee, Jl, Park, S, Keam, B, Yun, H, Kim, Y, Kang, B, Lee, K, Kim, C, Saad, M, Sundram, M, Calvo, D, Moreno, R, Rodriquez, J, Hernandez, C, van den Berg, H, De La Rosett, J, Van Moorse, R, Hunting, J, Hendriks, M, Kueppers, F, Gilling, P, Beaven, A, Holmes, M, Jassem, J, Oszukowska, E, Niezabitowski, J, Jaxa Larecka, D, Chwalinski, M, Swiniarski, P, Silva, C, Conceicãoa, P, Fraga, A, Mauricio, J, Rodrigues, T, Pinheiro, L, Lima, E, Palma Dos Reis, J, Volovat, C, Jinga, V, Harza, M, Alyasova, A, Budnik, N, Bychkov, Y, Izmaylov, A, Khvorosten, D, Matveev, V, Novsov, A, Vladimirov, V, Tevs, D, Sheveleva, L, Bulanov, A, Semenov, A, Fadeeva, N, Kulikov, E, Emelyanov, S, Karyakin, O, Shirinkin, V, Shkolnik, M, Lykov, A, Skopin, P, Kopyltsov, E, Mincik, I, Mir, O, Kliment, J, Mikurcik, E, Gajdos, M, Milichovsky, I, Malan, J, Bahlmann, J, Moshokoa, E, Madlala, T, Coetzee, L, Ribal, M, Miñana, B, Martinez Breijo, S, Carballido, J, Olmos, D, Requena, M, Morote, J, Damber, Je, Haggman, M, Nyman, C, Ljungberg, B, Bjartell, A, Ozen, H, Beduk, Y, Sozen, S, Cetinkaya, M, Ozyurt, M, Tansug, Z, Mungan, A, Tanidir, Y, Toktas, M, Hotko, E, Stus, V, Lyulko, O, Vinnyk, Y, Shparyk, Y, Sakalo, V, Bondarenko, I, Paramonov, V, Khareba, G, Hodos, V., Lääketieteen ja biotieteiden tiedekunta - Faculty of Medicine and Life Sciences, Tampere University, UCL - SSS/IREC/MONT - Pôle Mont Godinne, and UCL - (MGD) Service d'oncologie médicale

Subjects
Adult, Male, medicine.medical_specialty, Prednisolone, Kirurgia, anestesiologia, tehohoito, radiologia - Surgery, anesthesiology, intensive care, radiology, Abiraterone Acetate, 030232 urology & nephrology, Urology, 03 medical and health sciences, Prostate cancer, chemistry.chemical_compound, 0302 clinical medicine, Prednisone, Antineoplastic Combined Chemotherapy Protocols, 80 and over, medicine, Humans, Aged, Aged, 80 and over, Androgen Antagonists, Middle Aged, Neoplasm Metastasis, Prostatic Neoplasms, Steroid 17-alpha-Hydroxylase, Survival Analysis, Medicine (all), Gynecology, business.industry, Apalutamide, Abiraterone acetate, General Medicine, medicine.disease, Interim analysis, Clinical trial, Darolutamide, chemistry, 030220 oncology & carcinogenesis, business, medicine.drug
Abstract

Abiraterone acetate, a drug that blocks endogenous androgen synthesis, plus prednisone is indicated for metastatic castration-resistant prostate cancer. We evaluated the clinical benefit of abiraterone acetate plus prednisone with androgen-deprivation therapy in patients with newly diagnosed, metastatic, castration-sensitive prostate cancer. In this double-blind, placebo-controlled, phase 3 trial, we randomly assigned 1199 patients to receive either androgen-deprivation therapy plus abiraterone acetate (1000 mg daily, given once daily as four 250-mg tablets) plus prednisone (5 mg daily) (the abiraterone group) or androgen-deprivation therapy plus dual placebos (the placebo group). The two primary end points were overall survival and radiographic progression-free survival. After a median follow-up of 30.4 months at a planned interim analysis (after 406 patients had died), the median overall survival was significantly longer in the abiraterone group than in the placebo group (not reached vs. 34.7 months) (hazard ratio for death, 0.62; 95% confidence interval [CI], 0.51 to 0.76; P

Published
2017

2. Active surveillance for prostate cancer: a narrative review of clinical guidelines

Author

Bruinsma, SM, Bangma, CH, Carroll, PR, Leapman, MS, Rannikko, A, Petrides, N, Weerakoon, M, Bokhorst, LP, Roobol, MJ, Ehdaie, B, Fahey, M, Filson, C, Frydenberg, M, Gnanapragasam, V, Kakehi, Y, Kattan, M, Klotz, L, Lophatananon, A, Malouf, D, Moore, C, Muir, K, Parker, C, Pickles, T, Sanda, M, Steyerberg, E, Trock, B, Valdagni, R, Kwast, TVD, Villers, A, Gillespie, TW, Zhang, L, Gnanapragasam, Vincent [0000-0003-4722-4207], and Apollo - University of Cambridge Repository

Subjects
signs and symptoms, quality of life, prostate cancer, health care
Abstract

In the past decade active surveillance (AS) of men with localized prostate cancer has become an increasingly popular management option, and a range of clinical guidelines have been published on this topic. Existing guidelines regarding AS for prostate cancer vary widely, but predominantly state that the most suitable patients for AS are those with pretreatment clinical stage T1c or T2 tumours, serum PSA levels

Published
2016

3. Long-term safety of monthly zoledronic acid therapy beyond 1 year in patients with advanced cancer involving bone (LoTESS): A multicentre prospective phase 4 study

Author

Khalafallah, A.A., Slancar, M., Cosolo, W., Abdi, E., Chern, B., Woodfield, R.J., Copeman, M.C., Briscoe, K., Catley, L., Chirgwin, J., Craft, P., Frydenberg, M., Hamilton, K., Hill, J., Irving, I., Lowenthal, R., Sullivan, A., Thompson, J., Watson, A‐M., and Woodward, N.

Subjects
renal impairment, Male, 0301 basic medicine, medicine.medical_specialty, Bone disease, Kaplan-Meier Estimate, Zoledronic Acid, 03 medical and health sciences, Prostate cancer, 0302 clinical medicine, Breast cancer, Neoplasms, Internal medicine, Humans, Medicine, Longitudinal Studies, Prospective Studies, Adverse effect, bone metastasis, Aged, Aged, 80 and over, Bone Density Conservation Agents, Diphosphonates, business.industry, Imidazoles, Cancer, Bone metastasis, Original Articles, Middle Aged, medicine.disease, Surgery, osteonecrosis of the jaw, 030104 developmental biology, Zoledronic acid, Oncology, 030220 oncology & carcinogenesis, long‐term safety, Original Article, Female, Bone Diseases, business, Osteonecrosis of the jaw, medicine.drug
Abstract

Malignant bone disease can cause significant morbidity. Monthly zoledronic acid (ZOL) reduces skeletal complications; however, limited data are available regarding long-term safety. We aimed to assess efficacy and safety of ZOL beyond 1 year of treatment. We prospectively evaluated 73 patients; breast cancer (n = 29), castrate-resistant prostate cancer (n = 13), multiple myeloma (n = 31) from 2006 to 2008 in 19 cancer centres. All patients were diagnosed with bone disease and had completed 1-2 years of monthly ZOL (4 mg) and received a further 1-2 years of therapy following contemporary guidelines for managing risks of osteonecrosis of the jaw (ONJ) and renal toxicity. Overall rates of skeletal-related events (SREs), renal impairment and ONJ were assessed. Over the additional 1 year of treatment, only 5.5% (n = 4) of patients developed a new SRE. The overall Kaplan-Meier estimate for SRE incidence after 48 weeks on study was 6.75% (95 CI: 2.5-17.3). Although 51% of patients reported serious adverse events, only two cases were suspected as ZOL related. No patients had confirmed ONJ. The observed incidence of new renal impairment was 11% (none due to ZOL). Our study confirms the benefit over risk of continuing monthly ZOL for at least 2 years in patients with advanced cancer involving bone.

Published
2017

4. Targeted Prostate Cancer Screening in BRCA1 and BRCA2 Mutation Carriers: Results from the Initial Screening Round of the IMPACT Study

Author

Bancroft, EK, Page, EC, Castro, E, Lilja, H, Vickers, A, Sjoberg, D, Assel, M, Foster, CS, Mitchell, G, Drew, K, Maehle, L, Axcrona, K, Evans, DG, Bulman, B, Eccles, D, McBride, D, van Asperen, C, Vasen, H, Kiemeney, LA, Ringelberg, J, Cybulski, C, Wokolorczyk, D, Selkirk, C, Hulick, PJ, Bojesen, A, Skytte, AB, Lam, J, Taylor, L, Oldenburg, R, Cremers, R, Verhaegh, G, van Zelst-Stams, WA, Oosterwijk, JC, Blanco, I, Salinas, M, Cook, J, Rosario, DJ, Buys, S, Conner, T, Ausems, MG, Ong, KR, Hoffman, J, Domchek, S, Powers, J, Teixeira, MR, Maia, S, Foulkes, WD, Taherian, N, Ruijs, M, Helderman-van den Enden, AT, Izatt, L, Davidson, R, Adank, MA, Walker, L, Schmutzler, R, Tucker, K, Kirk, J, Hodgson, S, Harris, M, Douglas, F, Lindeman, GJ, Zgajnar, J, Tischkowitz, M, Clowes, VE, Susman, R, Cajal, TRY, Patcher, N, Gadea, N, Spigelman, A, van Os, T, Liljegren, A, Side, L, Brewer, C, Brady, AF, Donaldson, A, Stefansdottir, V, Friedman, E, Chen-Shtoyerman, R, Amor, DJ, Copakova, L, Barwell, J, Giri, VN, Murthy, V, Nicolai, N, Teo, SH, Greenhalgh, L, Strom, S, Henderson, A, McGrath, J, Gallagher, D, Aaronson, N, Ardern-Jones, A, Bangma, C, Dearnaley, D, Costello, P, Eyfjord, J, Rothwell, J, Falconer, A, Gronberg, H, Hamdy, FC, Johannsson, O, Khoo, V, Kote-Jarai, Z, Lubinski, J, Axcrona, U, Melia, J, McKinley, J, Mitra, AV, Moynihan, C, Rennert, G, Suri, M, Wilson, P, Killick, E, Moss, S, Eeles, RA, Taylor, N, Pope, J, Saya, S, Martin, S, Keating, D, Petelin, L, Murphy, M, Doherty, R, Pratt, S, Murphy, D, Cleeve, L, Miller, C, Stapleton, A, Chong, M, Suthers, G, Andrews, L, Duffy, J, Millard, R, Ward, R, Williams, R, Stricker, P, Bowman, M, Patel, M, O'Connell, S, Hunt, C, Smyth, C, Frydenberg, M, Shackleton, K, McGaughran, J, Boon, M, Pachter, N, Townshend, S, Schofield, L, Gleeson, M, Scott, R, Burke, J, Patterson, B, Bacic, S, Swindle, P, Aprikian, A, Bojeson, A, Cruger, D, Osther, P, Gerdes, AM, Rhiem, K, Luedtke-Heckenkamp, K, Ochsendorf, N, Fiddike, K, Sarin, R, Awatagiri, K, Ghonge, S, Kowtal, P, Mulgund, G, Bambury, R, Farrell, M, Gallagher, F, Ben-Yehoshua, SJ, Nissani, R, Appelman, Z, Moriel, E, Radice, P, Valdagni, R, Magnani, T, Meng, TH, Yoon, SY, Thong, MK, Kiemeney, B, Van der Luijt, RB, Moller, P, Brennhovd, B, Medvik, H, Hanslien, E, Peixoto, A, Henrique, R, Oliveira, J, Goncalves, N, Araujo, L, Seixas, M, Joao, PS, Nogueira, P, Krajc, M, Vrecar, A, Capella, G, Fisas, D, Balmana, J, Morote, J, Hjalm-Eriksson, M, Ekdahl, KJ, Carlsson, S, Hanson, H, Shanley, S, Goh, C, Wiggins, J, Kohut, K, Van As, N, Thompson, A, Ogden, C, Borley, N, Woodhouse, C, Kumar, P, Mercer, C, Paterson, J, Taylor, A, Newcombe, B, Halliday, D, Stayner, B, Fleming-Brown, D, Brice, G, Homfray, T, Hammond, C, Potter, A, Renton, C, Searle, A, Hill, K, Goodman, S, Garcia, L, Devlin, G, Everest, S, Nadolski, M, Jobson, I, Paez, E, Tomkins, S, Pichert, G, Jacobs, C, Langman, C, Weston, M, Dorkins, H, Melville, A, Kosicka-Slawinska, M, Cummings, C, Kiesel, V, Bartlett, M, Randhawa, K, Ellery, N, Male, A, Simon, K, Rees, K, Compton, C, Tidey, L, Nevitt, L, Ingram, S, Catto, J, Howson, J, Chapman, C, Cole, T, Heaton, T, Burgess, L, Longmuir, M, Watt, C, Duncan, A, Kockelbergh, R, Sattar, A, Kaemba, B, Sidat, Z, Patel, N, Siguake, K, Birt, A, Poultney, U, Umez-Eronini, N, Mom, J, Roberts, G, Woodward, A, Sutton, V, Cornford, P, Treherne, K, Griffiths, J, Cogley, L, Rubinstein, W, Brendler, C, Helfand, B, McGuire, M, Kaul, K, Shevrin, D, Weissman, S, Newlin, A, Vogel, K, Weiss, S, Goldgar, D, Venne, V, Stephenson, R, Dechet, C, Arun, B, Davis, JW, Yamamura, Y, and Gross, L

Subjects
Prostate cancer, BRCA1, BRCA2, Prostate-specific antigen, Targeted screening
Abstract

Background: Men with germline breast cancer 1, early onset (BRCA1) or breast cancer 2, early onset (BRCA2) gene mutations have a higher risk of developing prostate cancer (PCa) than noncarriers. IMPACT (Identification of Men with a genetic predisposition to ProstAte Cancer: Targeted screening in BRCA1/2 mutation carriers and controls) is an international consortium of 62 centres in 20 countries evaluating the use of targeted PCa screening in men with BRCA1/2 mutations. Objective: To report the first year's screening results for all men at enrolment in the study. Design, setting and participants: We recruited men aged 40-69 yr with germline BRCA1/2 mutations and a control group of men who have tested negative for a pathogenic BRCA1 or BRCA2 mutation known to be present in their families. All men underwent prostate-specific antigen (PSA) testing at enrolment, and those men with PSA > 3 ng/ml were offered prostate biopsy. Outcome measurements and statistical analysis: PSA levels, PCa incidence, and tumour characteristics were evaluated. The Fisher exact test was used to compare the number of PCa cases among groups and the differences among disease types. Results and limitations: We recruited 2481 men (791 BRCA1 carriers, 531 BRCA1 controls; 731 BRCA2 carriers, 428 BRCA2 controls). A total of 199 men (8%) presented with PSA > 3.0 ng/ml, 162 biopsies were performed, and 59 PCas were diagnosed (18 BRCA1 carriers, 10 BRCA1 controls; 24 BRCA2 carriers, 7 BRCA2 controls); 66% of the tumours were classified as intermediate-or high-risk disease. The positive predictive value (PPV) for biopsy using a PSA threshold of 3.0 ng/ml in BRCA2 mutation carriers was 48%-double the PPV reported in population screening studies. A significant difference in detecting intermediate-or high-risk disease was observed in BRCA2 carriers. Ninety-five percent of the men were white, thus the results cannot be generalised to all ethnic groups. Conclusions: The IMPACT screening network will be useful for targeted PCa screening studies in men with germline genetic risk variants as they are discovered. These preliminary results support the use of targeted PSA screening based on BRCA genotype and show that this screening yields a high proportion of aggressive disease. Patient summary: In this report, we demonstrate that germline genetic markers can be used to identify men at higher risk of prostate cancer. Targeting screening at these men resulted in the identification of tumours that were more likely to require treatment. (C) 2014 European Association of Urology. Published by Elsevier B. V. All rights reserved.

Published
2014

5. From indecision to precision: advances in imaging in metastatic prostate cancer.

Author

Bolton, D. and Frydenberg, M.

Subjects
*METASTASIS, *PROSTATE cancer, *CASTRATION-resistant prostate cancer
Abstract

Highlights from the article: There can be little doubt that advances in medical imaging have had the greatest influence on prostate cancer management, since the identification of PSA and its use as the dominant serum biomarker for prostate cancer. Currently available imaging formats using MRI and PET technology have become incorporated into the treatment algorithm for prostate cancer in a manner that could not have been conceived in the early phase of this current era of prostate cancer treatment.

Published
2019
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6. 1618P Clinical prognostic factors within the high volume subgroup of metastatic hormone sensitive prostate cancer (mHSPC) in ENZAMET (ANZUP 1304).

Author

Hamid, A.A., Thomas, H., Martin, A., Soon, Y.Y., Horvath, L.G., Zielinski, R., Thomson, A., Tan, H., Sandhu, S.K., Reaume, M.N., Pook, D.W., Parnis, F., McDermott, R.S., Lawrence, N., Frydenberg, M., Chi, K.N., Stockler, M.R., Davis, I.D., and Sweeney, C.

Subjects
*PROGNOSIS, *PROSTATE cancer, *METASTASIS, *HORMONES
Published
2024
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7. Lack of correlation between plasma and prostate tissue alpha-linolenic acid levels.

Author

Attar-Bashi, N. M., Frydenberg, M., Li, D., and Sinclair, A. J.

Subjects
*BLOOD plasma, *LINOLENIC acids, *PROSTATE cancer, *UNSATURATED fatty acids, *PROSTATECTOMY, *LIPIDS, *PHOSPHOLIPIDS, *STEROLS
Abstract

Background - Several epidemiological studies have reported a positive association between plasma alpha-linolenic acid (ALA) levels and the incidence of prostate cancer; however other studies have not supported this association, as recently reviewed. Objective - The aim of this study was to determine if there was a correlation between the plasma and prostate tissue levels of ALA and/or other n-3 polyunsaturated fatty acids (PUFA). Design - Plasma and prostate tissue were collected from patients undergoing prostate surgery, and prior to surgery completed a brief dietary questionnaire on the intake of dietary n-3 PUFA. Twenty-eight patients participated in the study, of which 20 were diagnosed with benign prostatic hyperplasia (BPH) and 8 with prostate cancer (PC). Outcome - The main lipids in the prostate tissue were phospholipids (PL) and sterols. The results showed that there was no significant correlation between plasma PL ALA and prostate tissue PL ALA concentrations (or proportions). There were, however, positive correlations between the proportions (not concentrations) of plasma and prostate tissue for EPA, DHA and total n-3 PUFA in the PL fraction. There was no significant difference in plasma and prostate tissue ALA and n-3 PUFA levels between the BPH patients and the PC patients for either the PL and triacylglycerol (TAG) fractions. Plasma ALA concentrations were significantly higher than the prostate tissue ALA levels for each subject. Conclusions - These pilot data do not show a significant association between plasma and prostate ALA in humans. [ABSTRACT FROM AUTHOR]

Published
2004

8. P340 - Combining MRI PI-RADS and PSMA-PET/CT PRIMARY score in a composite (P) score for more accurate diagnosis of clinically significant prostate cancer.

Author

Emmett, L., Papa, N., Hope, T., Fendler, W., Calais, J., Burger, I., Eiber, M., Barbato, F., Moon, D., Xue, A., Franklin, A., Thompson, J., Rasiah, K., Frydenberg, M., Yaxley, J., Buteau, J., Liu, V., Nguyen, A., Hsiao, E., and Stricker, P.

Subjects
*MAGNETIC resonance imaging, *DIAGNOSIS, *PROSTATE cancer
Published
2024
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9. A1237 - Baseline PSMA PET-CT is prognostic for treatment failure in men with intermediate-to-high risk prostate cancer: 54 months follow-up of the proPSMA randomised trial.

Author

Kasivisvanathan, V., Murphy, D.G., Link, E., Lawrentschuk, N., O'Brien, J., Buteau, J.P., Roberts, M., Francis, R.J., Tang, C., Vela, I., Thomas, P., Rutherford, N., Martin, J., Frydenberg, M., Shakher, R., Wong, L-M., Taubman, K., Lee, S.T., Hsiao, E., and Nottage, M.

Subjects
*POSITRON emission tomography computed tomography, *TREATMENT failure, *DISEASE risk factors, *PROSTATE cancer
Published
2023
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10. A0294 - Is there an impact of transperineal vs. transrectal MRI-targeted biopsy on the risk of upgrading and concordance with final pathology in prostate cancer patients undergoing radical prostatectomy? An EAU-YAU study.

Author

Zattoni, F., Marra, G., Martini, A., Kasivisvanathan, V., Grummet, J., Harkin, T., Ploussard, G., Olivier, J., Chiu, P.K., Valerio, M., Marquis, A., Gontero, P., Guo, H., Zhuang, J., Frydenberg, M., Moon, D., Kretschmer, A., Heidegger, I., Tilki, D., and Van Den Bergh, R.

Subjects
*ENDORECTAL ultrasonography, *PROSTATE cancer patients, *RADICAL prostatectomy, *PROSTATE cancer, *PATHOLOGY, *BIOPSY
Published
2023
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11. Enzalutamide with Standard First-Line Therapy in Metastatic Prostate Cancer.

Author

Davis, I. D., Martin, A. J., Stockier, M. R., Begbie, S., Chi, K. N., Chowdhury, S., Coskinas, X., Frydenberg, M., Hague, W. E., Horvath, L. G., Joshua, A. M., Lawrence, N. J., Marx, G., McCaffrey, J., McDermott, R., Mcjannett, M., North, S. A., Parnis, F., Parulekar, W., and Pook, D. W.

Subjects
*CASTRATION-resistant prostate cancer, *PROSTATE cancer, *METASTASIS, *PROSTATE-specific antigen, *PROGRESSION-free survival
Abstract

BACKGROUND Enzalutamide, an androgen-receptor inhibitor, has been associated with improved overall survival in men with castration-resistant prostate cancer. It is not known whether adding enzalutamide to testosterone suppression, with or without early docetaxel, will improve survival in men with metastatic, hormone-sensitive prostate cancer. METHODS In this open-label, randomized, phase 3 trial, we assigned patients to receive testosterone suppression plus either open-label enzalutamide or a standard nonsteroidal antiandrogen therapy (standard-care group). The primary end point was overall survival. Secondary end points included progression-free survival as determined by the prostate-specific antigen (PSA) level, clinical progression-free survival, and adverse events. RESULTS A total of 1125 men underwent randomization; the median follow-up was 34 months. There were 102 deaths in the enzalutamide group and 143 deaths in the standardcare group (hazard ratio, 0.67; 95% confidence interval [Cl], 0.52 to 0.86; P=0.002). Kaplan-Meier estimates of overall survival at 3 years were 80% (based on 94 events) in the enzalutamide group and 72% (based on 130 events) in the standard-care group. Better results with enzalutamide were also seen in PSA progression-free survival (174 and 333 events, respectively; hazard ratio, 0.39; PcO.001) and in clinical progressionfree survival (167 and 320 events, respectively; hazard ratio, 0.40; PcO.001). Treatment discontinuation due to adverse events was more frequent in the enzalutamide group than in the standard-care group (33 events and 14 events, respectively). Fatigue was more common in the enzalutamide group; seizures occurred in 7 patients in the enzalutamide group (1%) and in no patients in the standard-care group. CONCLUSIONS Enzalutamide was associated with significantly longer progression-free and overall survival than standard care in men with metastatic, hormone-sensitive prostate cancer receiving testosterone suppression. The enzalutamide group had a higher incidence of seizures and other toxic effects, especially among those treated with early docetaxel. [ABSTRACT FROM AUTHOR]

Published
2019
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12. Management of Patients with Advanced Prostate Cancer: Report of the Advanced Prostate Cancer Consensus Conference 2019

Author

Charles G. Drake, Matthew R. Smith, Almudena Zapatero, Charles J. Ryan, Philip W. Kantoff, Piet Ost, Inge M. van Oort, Ian D. Davis, Nicolas James, Matthew R. Sydes, Vedang Murthy, Martin E. Gleave, Maha Hussain, Michael S Hofman, Susan Halabi, Ignacio Duran, Oliver Sartor, Raya Leibowitz, Christopher P. Evans, Anders Bjartell, Ros Eeles, Mack Roach, Hiroyoshi Suzuki, Colin C. Pritchard, Levent Türkeri, Daniel Heinrich, Fred Saad, William Oh, Karim Fizazi, Himisha Beltran, Declan G. Murphy, Joe M. O'Sullivan, Thomas Steuber, Raja B. Khauli, Axel Heidenreich, Silke Gillessen, Eric J. Small, Robert E. Reiter, Juan Pablo Sade, Chris Logothetis, Tomasz M. Beer, Alberto Briganti, Mary-Ellen Taplin, Johann S. de Bono, Howard I. Scher, Eleni Efstathiou, Stefano Fanti, Darren M.C. Poon, Felix Y. Feng, Aurelius Omlin, Hind Mrabti, Chris Parker, Anwar R. Padhani, Kim N. Chi, Mark A. Rubin, Neal D. Shore, Nicolas Mottet, Alicia K. Morgans, Christopher Sweeney, Mark Frydenberg, Robert G. Bristow, Fernando C. Maluf, Robin Millman, Cora N. Sternberg, Ravindran Kanesvaran, Michael J. Morris, Noel W. Clarke, Gerhardt Attard, Alberto Bossi, Bertrand Tombal, Celestia S. Higano, Howard R. Soule, Acibadem University Dspace, UCL - SSS/IREC/CHEX - Pôle de chirgurgie expérimentale et transplantation, UCL - (SLuc) Service d'urologie, and Gillessen S, Attard G, Beer TM, Beltran H, Bjartell A, Bossi A, Briganti A, Bristow RG, Chi KN, Clarke N, Davis ID, de Bono J, Drake CG, Duran I, Eeles R, Efstathiou E, Evans CP, Fanti S, Feng FY, Fizazi K, Frydenberg M, Gleave M, Halabi S, Heidenreich A, Heinrich D, Higano CTS, Hofman MS, Hussain M, James N, Kanesvaran R, Kantoff P, Khauli RB, Leibowitz R, Logothetis C, Maluf F, Millman R, Morgans AK, Morris MJ, Mottet N, Mrabti H, Murphy DG, Murthy V, Oh WK, Ost P, O'Sullivan JM, Padhani AR, Parker C, Poon DMC, Pritchard CC, Reiter RE, Roach M, Rubin M, Ryan CJ, Saad F, Sade JP, Sartor O, Scher HI, Shore N, Small E, Smith M, Soule H, Sternberg CN, Steuber T, Suzuki H, Sweeney C, Sydes MR, Taplin ME, Tombal B, Türkeri L, van Oort I, Zapatero A, Omlin A.

Subjects
Male, Oncology, Aging, Advanced prostate cance, Hormone-sensitive prostate cancer, Imaging, SALVAGE RADIATION-THERAPY, Prostate cancer, QUALITY-OF-LIFE, Medicine and Health Sciences, Overall survival, Neoplasm Metastasis, DISSECTION, Cancer, Castration-resistant prostate cancer, Tumour genomic profiling, Advanced prostate cancer, Prostate Cancer, RADICAL PROSTATECTOMY, Consensus conference, Progression-free survival, TESTOSTERONE MEASUREMENTS, Urology & Nephrology, High-risk localised prostate cancer, Prostate cancer treatment, Local, Practice Guidelines as Topic, PHASE-II, Overall, profiling, CLINICAL-TRIALS, Urologic Diseases, medicine.medical_specialty, Urology, Clinical Sciences, Bone Neoplasms, HOT FLASHES, survival, All institutes and research themes of the Radboud University Medical Center, Internal medicine, Urological cancers Radboud Institute for Molecular Life Sciences [Radboudumc 15], Castration-naïve prostate cancer, Genetics, medicine, Humans, LYMPH-NODE, Neoplasm Staging, business.industry, Tumour genomic, Prostatic Neoplasms, Prostate-Specific Antigen, medicine.disease, Oligometastatic prostate cancer, LYMPH-NODE DISSECTION, Hormone sensitive prostate cancer, Neoplasm Recurrence, Good Health and Well Being, ANDROGEN-DEPRIVATION THERAPY, Neoplasm Recurrence, Local, FREE SURVIVAL, business
Abstract

Background: Innovations in treatments, imaging, and molecular characterisation in advanced prostate cancer have improved outcomes, but there are still many aspects of management that lack high-level evidence to inform clinical practice. The Advanced Prostate Cancer Consensus Conference (APCCC) 2019 addressed some of these topics to supplement guidelines that are based on level 1 evidence. Objective: To present the results from the APCCC 2019. Design, setting, and participants: Similar to prior conferences, experts identified 10 important areas of controversy regarding the management of advanced prostate cancer: locally advanced disease, biochemical recurrence after local therapy, treating the primary tumour in the metastatic setting, metastatic hormone-sensitive/naive prostate cancer, nonmetastatic castration-resistant prostate cancer, metastatic castration-resistant prostate cancer, bone health and bone metastases, molecular characterisation of tissue and blood, inter- and intrapatient heterogeneity, and adverse effects of hormonal therapy and their management. A panel of 72 international prostate cancer experts developed the programme and the consensus questions. Outcome measurements and statistical analysis: The panel voted publicly but anonymously on 123 predefined questions, which were developed by both voting and nonvoting panel members prior to the conference following a modified Delphi process. Results and limitations: Panellists voted based on their opinions rather than a standard literature review or formal meta-analysis. The answer options for the consensus questions had varying degrees of support by the panel, as reflected in this article and the detailed voting results reported in the Supplementary material. Conclusions: These voting results from a panel of prostate cancer experts can help clinicians and patients navigate controversial areas of advanced prostate management for which high-level evidence is sparse. However, diagnostic and treatment decisions should always be individualised based on patient-specific factors, such as disease extent and location, prior lines of therapy, comorbidities, and treatment preferences, together with current and emerging clinical evidence and logistic and economic constraints. Clinical trial enrolment for men with advanced prostate cancer should be strongly encouraged. Importantly, APCCC 2019 once again identified important questions that merit assessment in specifically designed trials. Patient summary: The Advanced Prostate Cancer Consensus Conference provides a forum to discuss and debate current diagnostic and treatment options for patients with advanced prostate cancer. The conference, which has been held three times since 2015, aims to share the knowledge of world experts in prostate cancer management with health care providers worldwide. At the end of the conference, an expert panel discusses and votes on predefined consensus questions that target the most clinically relevant areas of advanced prostate cancer treatment. The results of the voting provide a practical guide to help clinicians discuss therapeutic options with patients as part of shared and multidisciplinary decision making. (C) 2020 The Authors. Published by Elsevier B.V. on behalf of European Association of Urology.

Published
2020

13. What experts think about prostate cancer management during the COVID-19 pandemic: report from The Advanced Prostate Cancer Consensus Conference 2021

Author

Fabio Turco, Andrew Armstrong, Gerhardt Attard, Tomasz M. Beer, Himisha Beltran, Anders Bjartell, Alberto Bossi, Alberto Briganti, Rob G. Bristow, Muhammad Bulbul, Orazio Caffo, Kim N. Chi, Caroline Clarke, Noel Clarke, Ian D. Davis, Johann de Bono, Ignacio Duran, Ros Eeles, Eleni Efstathiou, Jason Efstathiou, Christopher P. Evans, Stefano Fanti, Felix Y. Feng, Karim Fizazi, Mark Frydenberg, Dan George, Martin Gleave, Susan Halabi, Daniel Heinrich, Celestia Higano, Michael S. Hofman, Maha Hussain, Nicholas James, Rob Jones, Ravindran Kanesvaran, Raja B. Khauli, Laurence Klotz, Raya Leibowitz, Christopher Logothetis, Fernando Maluf, Robin Millman, Alicia K. Morgans, Michael J. Morris, Nicolas Mottet, Hind Mrabti, Declan G. Murphy, Vedang Murthy, William K. Oh, Ngozi Ekeke Onyeanunam, Piet Ost, Joe M. O'Sullivan, Anwar R. Padhani, Christopher Parker, Darren M.C. Poon, Colin C. Pritchard, Danny M. Rabah, Dana Rathkopf, Robert E. Reiter, Mark Rubin, Charles J. Ryan, Fred Saad, Juan Pablo Sade, Oliver Sartor, Howard I. Scher, Neal Shore, Iwona Skoneczna, Eric Small, Matthew Smith, Howard Soule, Daniel Spratt, Cora N. Sternberg, Hiroyoshi Suzuki, Christopher Sweeney, Matthew Sydes, Mary-Ellen Taplin, Derya Tilki, Bertrand Tombal, Levent Türkeri, Hiroji Uemura, Hirotsugu Uemura, Inge van Oort, Kosj Yamoah, Dingwei Ye, Almudena Zapatero, Silke Gillessen, Aurelius Omlin, Tilki, Derya, Turco, F., Armstrong, A., Attard, G., Beer, T.M., Beltran, H., Bjartell, A., Bossi, A., Briganti, A., Bristow, R.G., Bulbul, M., Caffo, O., Chi, K.N., Clarke, C.S., Clarke, N., Davis, I.D., de Bono, J., Duran, I., Eeles, R., Efstathiou, E., Efstathiou, J., Evans, C.P., Fanti, S., Feng, F.Y., Fizazi, K., Frydenberg, M., George, D., Gleave, M., Halabi, S., Heinrich, D., Higano, C., Hofman, M.S., Hussain, M., James, N., Jones, R., Kanesvaran, R., Khauli, R.B., Klotz, L., Leibowitz, R., Logothetis, C., Maluf, F., Millman, R., Morgans, A.K., Morris, M.J., Mottet, N., Mrabti, H., Murphy, D.G., Murthy, V., Oh, W.K., Ekeke, O.N., Ost, P., O'Sullivan, J.M., Padhani, A.R., Parker, C., Poon, D.M.C., Pritchard, C.C., Rabah, D.M., Rathkopf, D., Reiter, R.E., Rubin, M., Ryan, C.J., Saad, F., Sade, J.P., Sartor, O., Scher, H.I., Shore, N., Skoneczna, I., Small, E., Smith, M., Soule, H., Spratt, D.E., Sternberg, C.N., Suzuki, H., Sweeney, C., Sydes, M.R., Taplin, M.-E., Tombal, B., Türkeri, L., Uemura, H., van Oort, I., Yamoah, K., Ye, D., Zapatero, A., Gillessen, S., Omlin, A., Koç University Hospital, School of Medicine, Acibadem University Dspace, UCL - SSS/IREC/CHEX - Pôle de chirgurgie expérimentale et transplantation, and UCL - (SLuc) Service d'urologie

Subjects
Male, COVID-19 Vaccines, Prostate cancer, Urology, COVID-19 boost injection, COVID-19 pandemic, COVID-19 vaccine, Prostate cancer management, Telemedicine, COVID-19, Prostatic Neoplasms, Androgen Antagonists, 610 Medicine & health, Urology and nephrology, SDG 3 - Good Health and Well-being, Urological cancers Radboud Institute for Molecular Life Sciences [Radboudumc 15], Humans, Pandemics
Abstract

Patients with advanced prostate cancer (APC) may be at greater risk for severe illness, hospitalisation, or death from coronavirus disease 2019 (COVID-19) due to male gender, older age, potential immunosuppressive treatments, or comorbidities. Thus, the optimal management of APC patients during the COVID-19 pandemic is complex. In October 2021, during the Advanced Prostate Cancer Consensus Conference (APCCC) 2021, the 73 voting members of the panel members discussed and voted on 13 questions on this topic that could help clinicians make treatment choices during the pandemic. There was a consensus for full COVID-19 vaccination and booster injection in APC patients. Furthermore, the voting results indicate that the expert's treatment recommendations are influenced by the vaccination status: the COVID-19 pandemic altered management of APC patients for 70% of the panellists before the vaccination was available but only for 25% of panellists for fully vaccinated patients. Most experts (71%) were less likely to use docetaxel and abiraterone in unvaccinated patients with metastatic hormone-sensitive prostate cancer. For fully vaccinated patients with high-risk localised prostate cancer, there was a consensus (77%) to follow the usual treatment schedule, whereas in unvaccinated patients, 55% of the panel members voted for deferring radiation therapy. Finally, there was a strong consensus for the use of telemedicine for monitoring APC patients. Patient summary: In the Advanced Prostate Cancer Consensus Conference 2021, the panellists reached a consensus regarding the recommendation of the COVID-19 vaccine in prostate cancer patients and use of telemedicine for monitoring these patients., NA

Published
2022

15. Management of Patients with Advanced Prostate Cancer:The Report of the Advanced Prostate Cancer Consensus Conference APCCC 2017

Author

Himisha Beltran, Celestia S. Higano, Fred Saad, Raja B. Khauli, William Oh, Avishay Sella, Gero Kramer, Bertrand Tombal, Felix Y. Feng, Chris Logothetis, Stefano Fanti, Howard R. Soule, Noel W. Clarke, Ian F. Tannock, Vedang Murthy, Howard I. Scher, Charles J. Ryan, Hiroyoshi Suzuki, Rodolfo Borges dos Reis, Colin C. Pritchard, Gedske Daugaard, Susan Halabi, Piet Ost, Matthew R. Smith, Michael J. Morris, Christopher Sweeney, Charles G. Drake, Pirkko-Liisa Kellokumpu-Lehtinen, Tomasz M. Beer, Anwar R. Padhani, Brett S. Carver, Riccardo Valdagni, Nicolas Mottet, Ros Eeles, Philip W. Kantoff, Aurelius Omlin, Eleni Efstathiou, Daniel Castellano, Mark Frydenberg, Neal D. Shore, Oliver Sartor, Christopher P. Evans, Martin E. Gleave, Fernando C. Maluf, Gerhardt Attard, Johann S. de Bono, Chris Parker, Ian D. Davis, Matthew R. Sydes, Alicia K. Morgans, Silke Gillessen, Thomas Wiegel, Cora N. Sternberg, Byung Ha Chung, Karim Fizazi, Axel Heidenreich, Alberto Bossi, Mack Roach, Robert G. Bristow, Nicolas James, Mark A. Rubin, and Gillessen S, Attard G, Beer TM, Beltran H, Bossi A, Bristow R, Carver B, Castellano D, Chung BH, Clarke N, Daugaard G, Davis ID, de Bono J, Dos Reis RB, Drake CG, Eeles R, Efstathiou E, Evans CP, Fanti S, Feng F, Fizazi K, Frydenberg M, Gleave M, Halabi S, Heidenreich A, Higano CS, James N, Kantoff P, Kellokumpu-Lehtinen PL, Khauli RB, Kramer G, Logothetis C, Maluf F, Morgans AK, Morris MJ, Mottet N, Murthy V, Oh W, Ost P, Padhani AR, Parker C, Pritchard CC, Roach M, Rubin MA, Ryan C, Saad F, Sartor O, Scher H, Sella A, Shore N, Smith M, Soule H, Sternberg CN, Suzuki H, Sweeney C, Sydes MR, Tannock I, Tombal B, Valdagni R, Wiegel T, Omlin A.

Subjects
Oncology, Male, Aging, 030232 urology & nephrology, Disease, METASTASIS-FREE SURVIVAL, Androgen deprivation therapy, Prostate cancer, 0302 clinical medicine, Voting, BRCA2 MUTATION CARRIERS, Medicine and Health Sciences, 610 Medicine & health, media_common, Cancer, Manchester Cancer Research Centre, Prostate Cancer, PHASE-III TRIAL, Urology & Nephrology, RANDOMIZED CONTROLLED-TRIAL, Prostate-specific antigen, OF-THE-LITERATURE, 030220 oncology & carcinogenesis, Practice Guidelines as Topic, METÁSTASE NEOPLÁSICA, Urologic Diseases, medicine.medical_specialty, Consensus, Urology, media_common.quotation_subject, Genetic counseling, Clinical Sciences, Consensu, Therapeutics, 03 medical and health sciences, Internal medicine, medicine, Humans, SYMPTOMATIC SKELETAL EVENTS, ESTRO-SIOG GUIDELINES, TERM-FOLLOW-UP, Castration-naive and castration-resistant prostate cancer, Neoplasm Staging, business.industry, ResearchInstitutes_Networks_Beacons/mcrc, Prostatic Neoplasms, Evidence-based medicine, medicine.disease, Advanced and high-risk localized prostate cancer, Oligometastatic prostate cancer, Clinical trial, LYMPH-NODE DISSECTION, Good Health and Well Being, Family medicine, ANDROGEN-DEPRIVATION THERAPY, business
Abstract

Background: In advanced prostate cancer (APC), successful drug development as well as advances in imaging and molecular characterisation have resulted in multiple areas where there is lack of evidence or low level of evidence. The Advanced Prostate Cancer Consensus Conference (APCCC) 2017 addressed some of these topics. Objective: To present the report of APCCC 2017. Design, setting, and participants: Ten important areas of controversy in APC management were identified: high-risk localised and locally advanced prostate cancer; "oligometastatic" prostate cancer; castration-naïve and castration-resistant prostate cancer; the role of imaging in APC; osteoclast-targeted therapy; molecular characterisation of blood and tissue; genetic counselling/testing; side effects of systemic treatment(s); global access to prostate cancer drugs. A panel of 60 international prostate cancer experts developed the program and the consensus questions. Outcome measurements and statistical analysis: The panel voted publicly but anonymously on 150 predefined questions, which have been developed following a modified Delphi process. Results and limitations: Voting is based on panellist opinion, and thus is not based on a standard literature review or meta-analysis. The outcomes of the voting had varying degrees of support, as reflected in the wording of this article, as well as in the detailed voting results recorded in Supplementary data. Conclusions: The presented expert voting results can be used for support in areas of management of men with APC where there is no high-level evidence, but individualised treatment decisions should as always be based on all of the data available, including disease extent and location, prior therapies regardless of type, host factors including comorbidities, as well as patient preferences, current and emerging evidence, and logistical and economic constraints. Inclusion of men with APC in clinical trials should be strongly encouraged. Importantly, APCCC 2017 again identified important areas in need of trials specifically designed to address them. Patient summary: The second Advanced Prostate Cancer Consensus Conference APCCC 2017 did provide a forum for discussion and debates on current treatment options for men with advanced prostate cancer. The aim of the conference is to bring the expertise of world experts to care givers around the world who see less patients with prostate cancer. The conference concluded with a discussion and voting of the expert panel on predefined consensus questions, targeting areas of primary clinical relevance. The results of these expert opinion votes are embedded in the clinical context of current treatment of men with advanced prostate cancer and provide a practical guide to clinicians to assist in the discussions with men with prostate cancer as part of a shared and multidisciplinary decision-making process. At the Advanced Prostate Cancer Consensus Conference, 10 important areas of controversy in advanced prostate cancer management were identified, discussed, and the experts voted on 150 predefined consensus questions. The full report of the results is summarised here.

Published
2018

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