2,956
Views
4
CrossRef citations to date
0
Altmetric
Clinical Trial Protocol

TALAPRO-3 Clinical Trial Protocol: Phase III Study of Talazoparib Plus Enzalutamide in Metastatic Castration-Sensitive Prostate Cancer

ORCID Icon, , ORCID Icon, , ORCID Icon, ORCID Icon, , , , & show all
Pages 493-505 | Received 13 Jun 2023, Accepted 18 Sep 2023, Published online: 26 Oct 2023

References

  • Key Statistics for Prostate Cancer. www.cancer.org/cancer/prostate-cancer/about/key-statistics.html (12 September 2022).
  • Prostate Cancer Statistics. www.wcrf.org/cancer-trends/prostate-cancer-statistics/ (21 September 2022).
  • Siegel DA, O’Neil ME, Richards TB, Dowling NF, Weir HK. Prostate cancer incidence and survival, by stage and race/ethnicity - United States, 2001-2017. MMWR Morb. Mortal. Wkly Rep. 69(41), 1473–1480 (2020).
  • Pinsky PF, Black A, Daugherty SE et al. Metastatic prostate cancer at diagnosis and through progression in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial. Cancer 125(17), 2965–2974 (2019).
  • Greenberg DC, Wright KA, Lophathanon A, Muir KR, Gnanapragasam VJ. Changing presentation of prostate cancer in a UK population--10 year trends in prostate cancer risk profiles in the East of England. Br. J. Cancer 109(8), 2115–2120 (2013).
  • Thurin NH, Rouyer M, Gross-Goupil M et al. Epidemiology of metastatic castration-resistant prostate cancer: a first estimate of incidence and prevalence using the French nationwide healthcare database. Cancer Epidemiol. 69, DOI:10.1016/j.canep.2020.101833 (2020).
  • Chen R, Ren S, Yiu MK et al. Prostate cancer in Asia: a collaborative report. Asian J. Urol. 1(1), 15–29 (2014).
  • Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2021. CA Cancer J. Clin. 71(1), 7–33 (2021).
  • Harada K, Shiota M, Minato A et al. Treatment strategies for metastatic castration-sensitive prostate cancer: from “all-comers” to “personalized” approach. Onco. Targets Ther. 14, 2967–2974 (2021).
  • Blas L, Shiota M, Eto M. Current status and future perspective on the management of metastatic castration-sensitive prostate cancer. Cancer Treat. Res. Commun. 32, DOI:10.1016/j.ctarc.2022.100606 (2022).
  • Freedland SJ, Sandin R, Sah J et al. Treatment patterns and survival in metastatic castration-sensitive prostate cancer in the US Veterans Health Administration. Cancer Med. 10(23), 8570–8580 (2021).
  • Kyriakopoulos CE, Chen YH, Carducci MA et al. Chemohormonal therapy in metastatic hormone-sensitive prostate cancer: long-term survival analysis of the randomized Phase III E3805 CHAARTED trial. J. Clin. Oncol. 36(11), 1080–1087 (2018).
  • Armstrong AJ, Azad AA, Iguchi T et al. Improved survival with enzalutamide in patients with metastatic hormone-sensitive prostate cancer. J. Clin. Oncol. 40(15), 1616–1622 (2022).
  • Chi KN, Chowdhury S, Bjartell A et al. Apalutamide in patients with metastatic castration-sensitive prostate cancer: final survival analysis of the randomized, double-blind, Phase III TITAN study. J. Clin. Oncol. 39(20), 2294–2303 (2021).
  • Fizazi K, Tran N, Fein L et al. Abiraterone acetate plus prednisone in patients with newly diagnosed high-risk metastatic castration-sensitive prostate cancer (LATITUDE): final overall survival analysis of a randomised, double-blind, phase 3 trial. Lancet Oncol. 20(5), 686–700 (2019).
  • Chi KN, Agarwal N, Bjartell A et al. Apalutamide for metastatic, castration-sensitive prostate cancer. N. Engl. J. Med. 381(1), 13–24 (2019).
  • Hahn AW, Higano CS, Taplin M-E, Ryan CJ, Agarwal N. Metastatic castration-sensitive prostate cancer: optimizing patient selection and treatment. Am. Soc. Clin. Oncol. Educ. Book. 38, 363–371 (2018).
  • Parker C, Castro E, Fizazi K et al. Prostate cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann. Oncol. 31(9), 1119–1134 (2020).
  • Chung JH, Dewal N, Sokol E et al. Prospective comprehensive genomic profiling of primary and metastatic prostate tumors. JCO Precis. Oncol. 3, DOI:10.1200/PO.18.00283 (2019).
  • Armenia J, Wankowicz SAM, Liu D et al. The long tail of oncogenic drivers in prostate cancer. Nat. Genet. 50(5), 645–651 (2018).
  • Castro E, Romero-Laorden N, Del Pozo A et al. PROREPAIR-B: a prospective cohort study of the impact of germline DNA repair mutations on the outcomes of patients with metastatic castration-resistant prostate cancer. J. Clin. Oncol. 37(6), 490–503 (2019).
  • Annala M, Vandekerkhove G, Khalaf D et al. Circulating tumor DNA genomics correlate with resistance to abiraterone and enzalutamide in prostate cancer. Cancer Discov. 8(4), 444–457 (2018).
  • Vandekerkhove G, Struss WJ, Annala M et al. Circulating tumor DNA abundance and potential utility in de novo metastatic prostate cancer. Eur. Urol. 75(4), 667–675 (2019).
  • Lord CJ, Ashworth A. PARP inhibitors: synthetic lethality in the clinic. Science 355(6330), 1152–1158 (2017).
  • Turk AA, Wisinski KB. PARP inhibitors in breast cancer: bringing synthetic lethality to the bedside. Cancer 124(12), 2498–2506 (2018).
  • Bryant HE, Schultz N, Thomas HD et al. Specific killing of BRCA2-deficient tumours with inhibitors of poly(ADP-ribose) polymerase. Nature 434(7035), 913–917 (2005).
  • Shen Y, Rehman FL, Feng Y et al. BMN 673, a novel and highly potent PARP1/2 inhibitor for the treatment of human cancers with DNA repair deficiency. Clin. Cancer Res. 19(18), 5003–5015 (2013).
  • Murai J, Huang SY, Renaud A et al. Stereospecific PARP trapping by BMN 673 and comparison with olaparib and rucaparib. Mol. Cancer Ther. 13(2), 433–443 (2014).
  • Agarwal N, Azad A, Shore ND et al. Talazoparib plus enzalutamide in metastatic castration-resistant prostate cancer: TALAPRO-2 Phase III study design. Future Oncol. 18(4), 425–436 (2022).
  • Murai J, Huang SN, Das BB et al. Trapping of PARP1 and PARP2 by clinical PARP inhibitors. Cancer Res. 72(21), 5588–5599 (2012).
  • U.S. Food and Drug Administration. TALZENNA® (talazoparib) prescribing information. (June 2023).
  • Agarwal N, Azad AA, Carles J et al. Talazoparib plus enzalutamide in men with first-line metastatic castration-resistant prostate cancer (TALAPRO-2): a randomised, placebo-controlled, phase 3 trial. Lancet 402, 291–303 (2023).
  • de Bono JS, Mehra N, Scagliotti GV et al. Talazoparib monotherapy in metastatic castration-resistant prostate cancer with DNA repair alterations (TALAPRO-1): an open-label, phase 2 trial. Lancet Oncol. 22(9), 1250–1264 (2021).
  • Feng Q, He B. Androgen receptor signaling in the development of castration-resistant prostate cancer. Front. Oncol. 9, 858 (2019).
  • Armstrong AJ, Szmulewitz RZ, Petrylak DP et al. ARCHES: a randomized, Phase III study of androgen deprivation therapy with enzalutamide or placebo in men with metastatic hormone-sensitive prostate cancer. J. Clin. Oncol. 37(32), 2974–2986 (2019).
  • Smith MR, Hussain M, Saad F et al. Darolutamide and survival in metastatic, hormone-sensitive prostate cancer. N. Engl. J. Med. 386(12), 1132–1142 (2022).
  • Fizazi K, Tran N, Fein L et al. Abiraterone plus prednisone in metastatic, castration-sensitive prostate cancer. N. Engl. J. Med. 377(4), 352–360 (2017).
  • James ND, de Bono JS, Spears MR et al. Abiraterone for prostate cancer not previously treated with hormone therapy. N. Engl. J. Med. 377(4), 338–351 (2017).
  • Schiewer MJ, Goodwin JF, Han S et al. Dual roles of PARP-1 promote cancer growth and progression. Cancer Discov. 2(12), 1134–1149 (2012).
  • Polkinghorn WR, Parker JS, Lee MX et al. Androgen receptor signaling regulates DNA repair in prostate cancers. Cancer Discov. 3(11), 1245–1253 (2013).
  • Li L, Karanika S, Yang G et al. Androgen receptor inhibitor–induced “BRCAness” and PARP inhibition are synthetically lethal for castration-resistant prostate cancer. Sci. Signal. 10(480), eaam7479 (2017).
  • Min A, Jang H, Kim S et al. Androgen receptor inhibitor enhances the antitumor effect of PARP inhibitor in breast cancer cells by modulating DNA damage response. Mol. Cancer Ther. 17(12), 2507–2518 (2018).
  • Chakraborty G, Armenia J, Mazzu YZ et al. Significance of BRCA2 and RB1 co-loss in aggressive prostate cancer progression. Clin. Cancer Res. 26(8), 2047–2064 (2020).
  • Agarwal N, Zhang T, Efstathiou E et al. The biology behind combining poly [ADP ribose] polymerase and androgen receptor inhibition for metastatic castration-resistant prostate cancer. Eur. J. Cancer 192, DOI:10.1016/j.ejca.2023.113249 (2023).
  • de Bono J, Mateo J, Fizazi K et al. Olaparib for metastatic castration-resistant prostate cancer. N. Engl. J. Med. 382(22), 2091–2102 (2020).
  • U.S. Food and Drug Administration . LYNPARZA® (olaparib) prescribing information. ( Revised May 2023).
  • LYNPARZA® (olaparib) Summary of Product Characteristics. www.medicines.org.uk/emc/product/9204/smpc (14 May 2021).
  • Abida W, Patnaik A, Campbell D et al. Rucaparib in men with metastatic castration-resistant prostate cancer harboring a BRCA1 or BRCA2 gene alteration. J. Clin. Oncol. 38(32), 3763–3772 (2020).
  • U.S. Food and Drug Administration . RUBRACA® (rucaparib) prescribing information. ( Revised June 2022).
  • Asim M, Tarish F, Zecchini HI et al. Synthetic lethality between androgen receptor signalling and the PARP pathway in prostate cancer. Nat. Commun. 8(1), 374 (2017).
  • Gui B, Gui F, Takai T et al. Selective targeting of PARP-2 inhibits androgen receptor signaling and prostate cancer growth through disruption of FOXA1 function. Proc. Natl Acad. Sci. USA 116(29), 14573–14582 (2019).
  • Chi KN, Rathkopf D, Smith MR et al. Niraparib and abiraterone acetate for metastatic castration-resistant prostate cancer. J. Clin. Oncol. 41(18), 3339–3351 (2023).
  • Clarke NW, Armstrong AJ, Thiery-Vuillemin A et al. Abiraterone and olaparib for metastatic castration-resistant prostate cancer. NEJM Evid. 1(9), DOI:10.1056/EVIDoa2200043 (2022).
  • Talazoparib + enzalutamide vs. enzalutamide monotherapy in mCRPC (TALAPRO-2) (NCT03395197). https://clinicaltrials.gov/ct2/show/NCT03395197 (23 February 2023).