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1. Niraparib plus abiraterone acetate with prednisone in patients with metastatic castration-resistant prostate cancer and homologous recombination repair gene alterations: second interim analysis of the randomized phase III MAGNITUDE trial

Author

Chi, K.N., Sandhu, S., Smith, M.R., Attard, G., Saad, M., Olmos, D., Castro, E., Roubaud, G., Pereira de Santana Gomes, A.J., Small, E.J., Rathkopf, D.E., Gurney, H., Jung, W., Mason, G.E., Dibaj, S., Wu, D., Diorio, B., Urtishak, K., del Corral, A., Francis, P., Kim, W., and Efstathiou, E.

Published
2023
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2. Deep, rapid, and durable prostate-specific antigen decline with apalutamide plus androgen deprivation therapy is associated with longer survival and improved clinical outcomes in TITAN patients with metastatic castration-sensitive prostate cancer

Author

Chowdhury, S., Bjartell, A., Agarwal, N., Chung, B.H., Given, R.W., Pereira de Santana Gomes, A.J., Merseburger, A.S., Özgüroğlu, M., Juárez Soto, Á., Uemura, H., Ye, D., Brookman-May, S.D., Londhe, A., Bhaumik, A., Mundle, S.D., Larsen, J.S., McCarthy, S.A., and Chi, K.N.

Published
2023
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3. Cabazitaxel versus abiraterone or enzalutamide in poor prognosis metastatic castration-resistant prostate cancer: a multicentre, randomised, open-label, phase II trial

Author

Annala, M., Fu, S., Bacon, J.V.W., Sipola, J., Iqbal, N., Ferrario, C., Ong, M., Wadhwa, D., Hotte, S.J., Lo, G., Tran, B., Wood, L.A., Gingerich, J.R., North, S.A., Pezaro, C.J., Ruether, J.D., Sridhar, S.S., Kallio, H.M.L., Khalaf, D.J., Wong, A., Beja, K., Schönlau, E., Taavitsainen, S., Nykter, M., Vandekerkhove, G., Azad, A.A., Wyatt, A.W., and Chi, K.N.

Published
2021
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4. HSD3B1 (1245A>C) germline variant and clinical outcomes in metastatic castration-resistant prostate cancer patients treated with abiraterone and enzalutamide: results from two prospective studies

Author

Almagro, E., Arranz, J.Á., Billalabeitia, E.G., Borrega, P., Castro, E., Contreras, J.A., Domenech, M., Escribano, R., Fernández-Parra, E., Gallardo, E., García-Carbonero, I., García, R., Garde, J., González del Alba, A., González, B., Hernández, A., Hernando, S., Jiménez, P., Laínez, N., Lorente, D., Luque, R., Martínez, E., Medina, A., Méndez-Vidal, M.J., Montesa, A., Morales, R., Olmos David, Pérez-Gracia, J.L., Pérez-Valderrama, B., Pinto, Á., Piulats, J., Puente, J., Querol, R., Rodríguez-Vida, A., Romero-Laorden, N., Sáez, M.I., Vázquez, S., Vélez, E., Villa-Guzmán, J.C., Villatoro, R., Zambrana, C., Khalaf, D.J., Aragón, I.M., Annala, M., Lozano, R., Taavitsainen, S., Finch, D.L., Vergidis, J., Cendón, Y., Oja, C., Pacheco, M.I., Zulfiqar, M., Gleave, M.E., Wyatt, A.W., Olmos, D., and Chi, K.N.

Published
2020
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6. Health-related quality of life and pain outcomes with [177Lu]Lu-PSMA-617 plus standard of care versus standard of care in patients with metastatic castration-resistant prostate cancer (VISION): a multicentre, open-label, randomised, phase 3 trial

Author

Fizazi, K., Herrmann, K., Krause, B.J., Rahbar, K., Chi, K.N., Morris, M.J., Sartor, O., Tagawa, S.T., Kendi, A.T., Vogelzang, N., Calais, J., Nagarajah, J., Wei, X.X., Koshkin, V.S., Beauregard, J.M., Chang, B., Ghouse, R., DeSilvio, M., Messmann, R.A., and Bono, J. de

Subjects
All institutes and research themes of the Radboud University Medical Center, Oncology, Tumours of the digestive tract Radboud Institute for Molecular Life Sciences [Radboudumc 14]
Abstract

Item does not contain fulltext BACKGROUND: In VISION, the prostate-specific membrane antigen (PSMA)-targeted radioligand therapy lutetium-177 [(177)Lu]Lu-PSMA-617 (vipivotide tetraxetan) improved radiographic progression-free survival and overall survival when added to protocol-permitted standard of care in patients with metastatic castration-resistant prostate cancer. Here, we report additional health-related quality of life (HRQOL), pain, and symptomatic skeletal event results. METHODS: This multicentre, open-label, randomised, phase 3 trial was conducted at 84 cancer centres in nine countries in North America and Europe. Eligible patients were aged 18 years or older; had progressive PSMA-positive metastatic castration-resistant prostate cancer; an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; and had previously received of at least one androgen receptor pathway inhibitor and one or two taxane-containing regimens. Patients were randomly assigned (2:1) to receive either [(177)Lu]Lu-PSMA-617 plus protocol-permitted standard of care ([(177)Lu]Lu-PSMA-617 group) or standard of care alone (control group) using permuted blocks. Randomisation was stratified by baseline lactate dehydrogenase concentration, liver metastases, ECOG performance status, and androgen receptor pathway inhibitor inclusion in standard of care. Patients in the [(177)Lu]Lu-PSMA-617 group received intravenous infusions of 7·4 gigabecquerel (GBq; 200 millicurie [mCi]) [(177)Lu]Lu-PSMA-617 every 6 weeks for four cycles plus two optional additional cycles. Standard of care included approved hormonal treatments, bisphosphonates, and radiotherapy. The alternate primary endpoints were radiographic progression-free survival and overall survival, which have been reported. Here we report the key secondary endpoint of time to first symptomatic skeletal event, and other secondary endpoints of HRQOL assessed with the Functional Assessment of Cancer Therapy-Prostate (FACT-P) and EQ-5D-5L, and pain assessed with the Brief Pain Inventory-Short Form (BPI-SF). Patient-reported outcomes and symptomatic skeletal events were analysed in all patients who were randomly assigned after implementation of measures designed to reduce the dropout rate in the control group (on or after March 5, 2019), and safety was analysed according to treatment received in all patients who received at least one dose of treatment. This trial is registered with ClinicalTrials.gov, NCT03511664, and is active but not recruiting. FINDINGS: Between June 4, 2018, and Oct 23, 2019, 831 patients were enrolled, of whom 581 were randomly assigned to the [(177)Lu]Lu-PSMA-617 group (n=385) or control group (n=196) on or after March 5, 2019, and were included in analyses of HRQOL, pain, and time to first symptomatic skeletal event. The median age of patients was 71 years (IQR 65-75) in the [(177)Lu]Lu-PSMA-617 group and 72·0 years (66-76) in the control group. Median time to first symptomatic skeletal event or death was 11·5 months (95% CI 10·3-13·2) in the [(177)Lu]Lu-PSMA-617 group and 6·8 months (5·2-8·5) in the control group (hazard ratio [HR] 0·50, 95% CI 0·40-0·62). Time to worsening was delayed in the [(177)Lu]Lu-PSMA-617 group versus the control group for FACT-P score (HR 0·54, 0·45-0·66) and subdomains, BPI-SF pain intensity score (0·52, 0·42-0·63), and EQ-5D-5L utility score (0·65, 0·54-0·78). Grade 3 or 4 haematological adverse events included decreased haemoglobin (80 [15%] of 529 assessable patients who received [(177)Lu]Lu-PSMA-617 plus standard of care vs 13 [6%] of 205 who received standard of care only), lymphocyte concentrations (269 [51%] vs 39 [19%]), and platelet counts (49 [9%] vs five [2%]). Treatment-related adverse events leading to death occurred in five (1%) patients who received [(177)Lu]Lu-PSMA-617 plus standard of care (pancytopenia [n=2], bone marrow failure [n=1], subdural haematoma [n=1], and intracranial haemorrhage [n=1]) and no patients who received standard of care only. INTERPRETATION: [(177)Lu]Lu-PSMA-617 plus standard of care delayed time to worsening in HRQOL and time to skeletal events compared with standard of care alone. These findings support the use of [(177)Lu]Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer who received previous androgen receptor pathway inhibitor and taxane treatment. FUNDING: Advanced Accelerator Applications (Novartis). 01 juni 2023

Published
2023
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21. 258MO Niraparib plus abiraterone acetate plus prednisone (NIRA+AAP) as first-line treatment in patients with BRCA+ metastatic castration-resistant prostate cancer (mCRPC): Second interim analysis in the Asian subgroup of the MAGNITUDE study.

Author

Saad, M., Chi, K.N., Sandhu, S.K., Attard, G., Ye, D., Li, L., Jung, W., Pang, S-T., Francis, P.S.J., Li, S., Dibaj, S., Zhang, J., Kim, W., Lopez-Gitlitz, A., Wu, D., Singh, A., De Vries, R., Zhang, L., and Lee, J.Y.

Subjects
*CASTRATION-resistant prostate cancer, *ABIRATERONE acetate, *SUBGROUP analysis (Experimental design), *PREDNISONE
Published
2023
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22. 158MO Niraparib with abiraterone acetate and prednisone (NIRA+AAP) as first-line therapy in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) with homologous recombination repair (HRR+) gene alterations: Asian subgroup analysis of the MAGNITUDE study

Author

Binti Saad, M., Chi, K.N., Jung, W., Pang, S-T., Attard, G., Sandhu, S.K., Mason, G.E., del Corral, A., Wang, G., Wu, D., Diorio, B., Lopez-Gitlitz, A., and Lee, J.Y.

Subjects
*CASTRATION-resistant prostate cancer, *ABIRATERONE acetate, *GENE targeting, *PREDNISONE
Published
2022
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23. 95P - Evaluation of markers associated with efficacy of abiraterone acetate plus prednisone (AAP) in patients (pts) with castration-sensitive prostate cancer (mCSPC) from the LATITUDE study.

Author

Chi, K.N., Thomas, S., Gormley, M., Shen, D., Joshi, S., Tran, N., Smith, M., Ricci, D., and Fizazi, K.

Subjects
*CASTRATION-resistant prostate cancer, *PROSTATE cancer, *ABIRATERONE acetate, *PROPORTIONAL hazards models, *DNA sequencing, *PROGNOSIS, *PREDNISONE
Abstract

AAP and androgen deprivation therapy (ADT) treatment significantly improved overall survival (OS) and radiological progression-free survival (rPFS) in mCSPC pts with adverse prognostic factors. This analysis was aimed to identify predictive markers associated with response or resistance to AAP to guide combination and subsequent therapies. DNA (n = 43) and RNA (n = 48) extracted from archived tumor samples from the LATITUDE study were sequenced using next generation and targeted DNA sequencing. Androgen receptor (AR) anomalies (copy number changes and mutations), frequency of DNA repair deficient (DRD: BRCA1/2, ATM, BRIP1, CHEK2, PALB2, FANCA, HDAC2) tumors and other resistant markers were probed. ARV7 expression was assessed in archived tumors (n = 105) by immunohistochemistry. Associations of biomarkers with rPFS and OS were assessed using univariate cox proportional hazards models. Of 105 treatment-naïve tumor samples tested, none of them met previously defined H-score cut off for ARV7 staining of > 5%, while 4/105 (4%) showed >1% ARV7 staining. A non-synonymous AR mutation (E654K) was detected in one sample (1/43), while none of the samples showed AR amplification. Impact of ARV7 expression on clinical outcomes was inconclusive due to small sample size of positive results. DRD tumors were observed at an overall frequency of 6/42 pts (14.3%: 4 biallelic), 4/30 pts (13.3%; 3 biallelic) in the AAP arm and 2/12 pts (16.7%: 1 biallelic) in control arm. Incidences of BRCA1/2 were only observed in AAP arm at a frequency of 2/30 (6.7%). In the AAP arm, shorter PFS was observed for DRD+ vs DRD– cohort (median 21.01 vs 24.14 mo; HR: 3.9; 95% CI: 1.1-12.1; p = 0.03). Genomic alterations were observed in PTEN (32.5%), TMPRSS2 (30%), TP53 (25.55), SPOP (20.9%) and APC (13.9%) genes, however, associations with clinical outcomes were not meaningful due to fewer samples and events. AR splice variants and mutations were absent/rare in treatment naïve tumor samples from men with castrate-sensitive prostate cancers. The DRD+ cohort appears to show poorer rPFS outcome in AAP treated men. NCT01715285. Shweta Pitre, MPharm, ISMPP CMPP™ (SIRO Clinpharm Pvt. Ltd., India) provided writing assistance and Namit Ghildyal, PhD (Janssen Global Services, LLC) provided additional editorial support. Janssen Research and Development, LLC. Janssen Research and Development, LLC. K.N. Chi: Research grant/Funding (self): Janssen Pharmaceuticals, Astellas Pharma, Amgen, Bayer, Novartis, Sanofi, Exelixis, Tokai Pharmaceuticals, Oncogenex, Teva; Advisory/Consultancy: ESSA, Astellas Pharma, Janssen Pharmaceuticals, Sanofi, Lilly/ImClone, Amgen, Bayer, Takeda Pharmaceuticals; Honoraria (self): Sanofi, Janssen Pharmaceuticals, Astellas Pharma. S. Thomas: Shareholder/Stockholder/Stock options, Full/Part-time employment: Janssen Research & Development. M. Gormley: Shareholder/Stockholder/Stock options, Full/Part-time employment: Janssen Research & Development. D. Shen: Shareholder/Stockholder/Stock options, Full/Part-time employment: Janssen Research & Development. S. Joshi: Full/Part-time employment: Janssen Research & Development. N. Tran: Shareholder/Stockholder/Stock options, Full/Part-time employment: Janssen Research & Development. M. Smith: Shareholder/Stockholder/Stock options, Full/Part-time employment: Janssen Research & Development. D. Ricci: Shareholder/Stockholder/Stock options, Full/Part-time employment: Janssen Research & Development. K. Fizazi: Advisory/Consultancy, Received personal fees: Amgen; Advisory/Consultancy, Received personal fees: Astellas; Advisory/Consultancy, Received personal fees: AstraZeneca; Advisory/Consultancy, Received personal fees: Bayer; Advisory/Consultancy, Received personal fees: Clovis; Advisory/Consultancy, Received personal fees: Curevac; Advisory / Consultancy, Received personal fees: Essa; Advisory/Consultancy, Received personal fees: Genentech; Advisory/Consultancy, Received personal fees: Janssen; Advisory/Consultancy, Received personal fees: Merck Sharp and Dohme; Advisory/Consultancy, Received personal fees: Orion; Advisory/Consultancy, Received personal fees: Sanofi. [ABSTRACT FROM AUTHOR]

Published
2019
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29. 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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30. 1599P Symptomatic skeletal events, health-related quality of life and pain in a phase III study of [177Lu]Lu-PSMA-617 in taxane-naive patients with PSMA-positive metastatic castration-resistant prostate cancer: Third interim analysis of PSMAfore.

Author

Fizazi, K., Morris, M.J., Shore, N.D., Chi, K.N., Crosby, M., de Bono, J.S., Herrmann, K., Roubaud, G., Nagarajah, J., Fleming, M.T., Lewis, B., Nordquist, L.T., Castellano Gauna, D.E., Carnahan, N., Ghebremariam, S., Hertelendi, M., and Sartor, O.

Subjects
*CASTRATION-resistant prostate cancer, *QUALITY of life
Published
2024
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35. 582P Health-related quality of life (HRQoL) at final analysis of the GALAHAD study of niraparib in patients with metastatic castration-resistant prostate cancer (mCRPC) and DNA repair defects (DRD).

Author

Smith, M.R., Sandhu, S.K., George, D.J., Chi, K.N., Saad, F., Thiery-Vuillemin, A., Stahl, O., Olmos, D., Danila, D., Gafanov, R., Castro, E., Moon, H., Joshua, A.M., Mason, G.E., Espina, B.M., Liu, Y., Bevans, K.B., Lopez-Gitlitz, A., Francis, P., and Fizazi, K.

Subjects
*CASTRATION-resistant prostate cancer, *DNA repair, *QUALITY of life
Published
2021
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36. 576MO Health-related quality of life (HRQoL), pain and safety outcomes in the phase III VISION study of 177Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer.

Author

Fizazi, K., Herrmann, K., Krause, B.J., Rahbar, K., Chi, K.N., Morris, M.J., Sartor, O., Tagawa, S.T., Kendi, A.T., Vogelzang, N.J., Calais, J., Nagarajah, J., Wei, X.X., Koshkin, V.S., Beauregard, J-M., Chang, B., DeSilvio, M., Messmann, R.A., and de Bono, J.

Subjects
*CASTRATION-resistant prostate cancer, *QUALITY of life, *VISION
Published
2021
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37. 1400P Efficacy and safety of 177Lu-PNT2002 prostate-specific membrane antigen (PSMA) therapy in metastatic castration resistant prostate cancer (mCRPC): Initial results from SPLASH.

Author

Hansen, A.R., Probst, S., Tutrone, R.F., Osman, M.M., Delpassand, E.S., Nordquist, L.T., Viglianti, B.L., Michalski, J.M., Beauregard, J-M., Oz, O.K., Courtney, K., Jensen, J., Wu, W., Fleshner, N., Sartor, O., Chi, K.N., and Tagawa, S.T.

Subjects
*CASTRATION-resistant prostate cancer, *METASTASIS
Published
2022
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38. LBA4 IPATential150: Phase III study of ipatasertib (ipat) plus abiraterone (abi) vs placebo (pbo) plus abi in metastatic castration-resistant prostate cancer (mCRPC).

Author

de Bono, J.S., Bracarda, S., Sternberg, C.N., Chi, K.N., Olmos, D., Sandhu, S., Massard, C., Matsubara, N., Alekseev, B., Gafanov, R., Parnis, F., Buchschacher, G.L., Corrales, L., Borre, M., Vasconcelos Alves, G., Garcia, J., Harle-Yge, M-L., Chen, G., Wongchenko, M.J., and Sweeney, C.

Subjects
*CASTRATION-resistant prostate cancer, *PLACEBOS
Published
2020
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40. O6 - Patient-reported outcomes (PROs) From TITAN: A phase 3, randomized, double-blind study of apalutamide (APA) versus placebo (PBO) added to androgen deprivation therapy (ADT) in patients (pts) with metastatic castration-sensitive prostate cancer (mCSPC)

Author

Agarwal, N., Mcquarrie, K., Bjartell, A., Chowdhury, S., Pereira De Santana Gomes, A.J., Chung, B.H., Özgüroğlu, M., Juárez Soto, Á., Merseburger, A.S., Uemura, H., Ye, D-W., Given, R., Miladinovic, B., Dearden, L., Deprince, K., Naini, V., Lopez-Gitlitz, A., and Chi, K.N.

Subjects
*PROSTATE cancer, *ANDROGENS, *PLACEBOS, *PATIENTS
Published
2019
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42. 610O Final overall survival (OS) analysis of PROfound: Olaparib vs physician's choice of enzalutamide or abiraterone in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) and homologous recombination repair (HRR) gene alterations.

Author

de Bono, J.S., Mateo, J., Fizazi, K., Saad, F., Shore, N., Sandhu, S., Chi, K.N., Sartor, O., Agarwal, N., Olmos, D., Thiery-Vuillemin, A., Twardowski, P., Roubaud, G., Ozguroglu, M., Kang, J., Burgents, J., Gresty, C., Corcoran, C., Adelman, C.A., and Hussain, M.

Subjects
*CASTRATION-resistant prostate cancer, *OVERALL survival, *PHYSICIANS, *OLAPARIB
Published
2020
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