Sacks LV, Shamsuddin HH, Yasinskaya YI, Bouri K, Lanthier ML, Sherman RE. Scientific and regulatory reasons for delay and denial of FDA approval of initial applications for new drugs, 2000-2012. Jama-J Am Med Assoc. 2014;311(4):378–84.
Article
CAS
Google Scholar
Fogel DB. Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: a review. Cont Clin Trial Comm. 2018;11:156–64.
Article
Google Scholar
Hui D, Glitza I, Chisholm G, Yennu S, Bruera E. Attrition rates, reasons, and predictive factors in supportive care and palliative oncology clinical trials. Cancer. 2013;119(5):1098–105.
Article
PubMed
Google Scholar
Getz KA, Zuckerman R, Cropp AB, Hindle AL, Krauss R, Kaitin KI. Measuring the incidence, causes, and repercussions of protocol amendments. Drug Inf J. 2011;45(3):265–75.
Article
Google Scholar
Brand DH, Tree AC, Ostler P, van der Voet H, Loblaw A, Chu W, et al. Intensity-modulated fractionated radiotherapy versus stereotactic body radiotherapy for prostate cancer (PACE-B): acute toxicity findings from an international, randomised, open-label, phase 3, non-inferiority trial. Lancet Oncol. 2019;20(11):1531–43.
Article
PubMed
PubMed Central
Google Scholar
Widmark A, Gunnlaugsson A, Beckman L, Thellenberg-Karlsson C, Hoyer M, Lagerlund M, et al. Ultra-hypofractionated versus conventionally fractionated radiotherapy for prostate cancer: 5-year outcomes of the HYPO-RT-PC randomised, non-inferiority, phase 3 trial. Lancet. 2019;394(10196):385–95.
Article
PubMed
Google Scholar
Kerkmeijer LGW, Groen VH, Pos FJ, Haustermans K, Monninkhof EM, Smeenk RJ, et al. Focal boost to the Intraprostatic tumor in external beam radiotherapy for patients with localized prostate Cancer: results from the FLAME randomized phase III trial. J Clin Oncol. 2021;39(7):787–96.
Article
CAS
PubMed
Google Scholar
Bettermann AS, Zamboglou C, Kiefer S, Jilg CA, Spohn S, Kranz-Rudolph J, et al. [(68) Ga-]PSMA-11 PET/CT and multiparametric MRI for gross tumor volume delineation in a slice by slice analysis with whole mount histopathology as a reference standard - implications for focal radiotherapy planning in primary prostate cancer. Radiother Oncol. 2019;141:214–9.
Article
PubMed
Google Scholar
Draulans C, De Roover R, van der Heide UA, Kerkmeijer L, Smeenk RJ, Pos F, et al. Optimal (68) Ga-PSMA and (18) F-PSMA PET window levelling for gross tumour volume delineation in primary prostate cancer. Eur J Nucl Med Mol Imaging. 2021;48(4):1211–8.
Article
PubMed
Google Scholar
Eiber M, Weirich G, Holzapfel K, Souvatzoglou M, Haller B, Rauscher I, et al. Simultaneous (68) Ga-PSMA HBED-CC PET/MRI improves the localization of primary prostate Cancer. Eur Urol. 2016;70(5):829–36.
Article
CAS
PubMed
Google Scholar
Kuten J, Fahoum I, Savin Z, Shamni O, Gitstein G, Hershkovitz D, et al. Head-to-head comparison of (68) Ga-PSMA-11 with (18) F-PSMA-1007 PET/CT in staging prostate Cancer using histopathology and Immunohistochemical analysis as a reference standard. J Nucl Med. 2020;61(4):527–32.
Article
CAS
PubMed
Google Scholar
Spohn S, Jaegle C, Fassbender TF, Sprave T, Gkika E, Nicolay NH, et al. Intraindividual comparison between (68) Ga-PSMA-PET/CT and mpMRI for intraprostatic tumor delineation in patients with primary prostate cancer: a retrospective analysis in 101 patients. Eur J Nucl Med Mol Imaging. 2020;47(12):2796–803.
Article
CAS
PubMed
PubMed Central
Google Scholar
Zamboglou C, Kramer M, Kiefer S, Bronsert P, Ceci L, Sigle A, et al. The impact of the co-registration technique and analysis methodology in comparison studies between advanced imaging modalities and whole-mount-histology reference in primary prostate cancer. Sci Rep. 2021;11(1):5836.
Article
CAS
PubMed
PubMed Central
Google Scholar
Sacristán JA, Aguarón A, Avendaño-Solá C, Garrido P, Carrión J, Gutiérrez A, et al. Patient involvement in clinical research: why, when, and how. Patient Prefer Adherence. 2016;10:631–40.
Article
PubMed
PubMed Central
Google Scholar
Draulans C, De Roover R, van der Heide UA, Haustermans K, Pos F, Smeenk RJ, et al. Stereotactic body radiation therapy with optional focal lesion ablative microboost in prostate cancer: topical review and multicenter consensus. Radiother Oncol. 2019;140:131–42.
Article
PubMed
Google Scholar
Wilkins A, Naismith O, Brand D, Fernandez K, Hall E, Dearnaley D, et al. Derivation of dose/volume constraints for the Anorectum from clinician- and patient-reported outcomes in the CHHiP trial of radiation therapy fractionation. Int J Radiat Oncol Biol Phys. 2020;106(5):928–38.
Article
PubMed
Google Scholar
Zamboglou C, Sachpazidis I, Koubar K, Drendel V, Wiehle R, Kirste S, et al. Evaluation of intensity modulated radiation therapy dose painting for localized prostate cancer using (68) Ga-HBED-CC PSMA-PET/CT: a planning study based on histopathology reference. Radiother Oncol. 2017;123(3):472–7.
Article
PubMed
Google Scholar
Spohn SKB, Sachpazidis I, Wiehle R, Thomann B, Sigle A, Bronsert P, et al. Influence of urethra sparing on tumor control probability and Normal tissue complication probability in focal dose escalated Hypofractionated radiotherapy: a planning study based on histopathology reference. Front Oncol. 2021;11:652678.
Article
PubMed
PubMed Central
Google Scholar
Zamboglou C, Thomann B, Koubar K, Bronsert P, Krauss T, Rischke HC, et al. Focal dose escalation for prostate cancer using (68) Ga-HBED-CC PSMA PET/CT and MRI: a planning study based on histology reference. Radiat Oncol. 2018;13(1):81.
Article
PubMed
PubMed Central
Google Scholar
Zamboglou C, Klein CM, Thomann B, Fassbender TF, Rischke HC, Kirste S, et al. The dose distribution in dominant intraprostatic tumour lesions defined by multiparametric MRI and PSMA PET/CT correlates with the outcome in patients treated with primary radiation therapy for prostate cancer. Radiat Oncol. 2018;13(1):65.
Article
PubMed
PubMed Central
Google Scholar
Incrocci L, Wortel RC, Alemayehu WG, Aluwini S, Schimmel E, Krol S, et al. Hypofractionated versus conventionally fractionated radiotherapy for patients with localised prostate cancer (HYPRO): final efficacy results from a randomised, multicentre, open-label, phase 3 trial. Lancet Oncol. 2016;17(8):1061–9.
Article
PubMed
Google Scholar
Arcangeli G, Saracino B, Arcangeli S, Gomellini S, Petrongari MG, Sanguineti G, et al. Moderate Hypofractionation in high-risk, organ-confined prostate Cancer: final results of a phase III randomized trial. J Clin Oncol. 2017;35(17):1891–7.
Article
CAS
PubMed
Google Scholar
Bruner DW, Pugh SL, Lee WR, Hall WA, Dignam JJ, Low D, et al. Quality of life in patients with Low-risk prostate Cancer treated with Hypofractionated vs conventional radiotherapy: a phase 3 randomized clinical trial. JAMA Oncol. 2019;5(5):664–70.
Article
PubMed
Google Scholar
Catton CN, Lukka H, Gu CS, Martin JM, Supiot S, Chung PWM, et al. Randomized trial of a Hypofractionated radiation regimen for the treatment of localized prostate Cancer. J Clin Oncol. 2017;35(17):1884–90.
Article
CAS
PubMed
Google Scholar
Dearnaley D, Syndikus I, Mossop H, Khoo V, Birtle A, Bloomfield D, et al. Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: 5-year outcomes of the randomised, non-inferiority, phase 3 CHHiP trial. Lancet Oncol. 2016;17(8):1047–60.
Article
PubMed
PubMed Central
Google Scholar
Alayed Y, Cheung P, Vesprini D, Liu S, Chu W, Chung H, et al. SABR in high-risk prostate Cancer: outcomes from 2 prospective clinical trials with and without elective nodal irradiation. Int J Radiat Oncol Biol Phys. 2019;104(1):36–41.
Article
PubMed
Google Scholar
Bauman G, Ferguson M, Lock M, Chen J, Ahmad B, Venkatesan VM, et al. A phase 1/2 trial of brief androgen suppression and stereotactic radiation therapy (FASTR) for high-risk prostate Cancer. Int J Radiat Oncol Biol Phys. 2015;92(4):856–62.
Article
PubMed
Google Scholar
Callan L, Bauman G, Chen J, Lock M, Sexton T, D'Souza D, et al. A phase I/II trial of fairly brief androgen suppression and stereotactic radiation therapy for high-risk prostate Cancer (FASTR-2): preliminary results and toxicity analysis. Adv Radiat Oncol. 2019;4(4):668–73.
Article
PubMed
PubMed Central
Google Scholar
King CR, Freeman D, Kaplan I, Fuller D, Bolzicco G, Collins S, et al. Stereotactic body radiotherapy for localized prostate cancer: pooled analysis from a multi-institutional consortium of prospective phase II trials. Radiother Oncol. 2013;109(2):217–21.
Article
PubMed
Google Scholar
Musunuru HB, D'Alimonte L, Davidson M, Ho L, Cheung P, Vesprini D, et al. Phase 1-2 study of stereotactic ablative radiotherapy including regional lymph node irradiation in patients with high-risk prostate Cancer (SATURN): early toxicity and quality of life. Int J Radiat Oncol Biol Phys. 2018;102(5):1438–47.
Article
PubMed
Google Scholar
Zilli T, Jorcano S, Bral S, Rubio C, Bruynzeel AME, Oliveira A, et al. Once-a-week or every-other-day urethra-sparing prostate cancer stereotactic body radiotherapy, a randomized phase II trial: 18 months follow-up results. Cancer Med. 2020;9(9):3097–106.
Article
PubMed
PubMed Central
Google Scholar
Marvaso G, Riva G, Ciardo D, Gandini S, Fodor C, Zerini D, et al. “Give me five” ultra-hypofractionated radiotherapy for localized prostate cancer: non-invasive ablative approach. Med Oncol. 2018;35(6):96.
Article
PubMed
Google Scholar
Mottet N, Bellmunt J, Bolla M, Briers E, Cumberbatch MG, De Santis M, et al. EAU-ESTRO-SIOG guidelines on prostate Cancer. Part 1: screening, diagnosis, and local treatment with curative intent. Eur Urol. 2017;71(4):618–29.
Article
PubMed
Google Scholar
Moon DH, Basak RS, Usinger DS, Dickerson GA, Morris DE, Perman M, et al. Patient-reported quality of life following stereotactic body radiotherapy and conventionally fractionated external beam radiotherapy compared with active surveillance among men with localized prostate Cancer. Eur Urol. 2019;76(3):391–7.
Article
PubMed
PubMed Central
Google Scholar
Onjukka E, Uzan J, Baker C, Howard L, Nahum A, Syndikus I. Twenty fraction prostate radiotherapy with intra-prostatic boost: results of a pilot study. Clin Oncol (R Coll Radiol). 2017;29(1):6–14.
Article
CAS
Google Scholar
Murray JR, Tree AC, Alexander EJ, Sohaib A, Hazell S, Thomas K, et al. Standard and Hypofractionated dose escalation to Intraprostatic tumor nodules in localized prostate Cancer: efficacy and toxicity in the DELINEATE trial. Int J Radiat Oncol Biol Phys. 2020;106(4):715–24.
Article
PubMed
Google Scholar
Draulans C, van der Heide UA, Haustermans K, Pos FJ, van der Voort van Zyp J, De Boer H, et al. Primary endpoint analysis of the multicentre phase II hypo-FLAME trial for intermediate and high risk prostate cancer. Radiother Oncol 2020;147:92–98.
Herrera FG, Valerio M, Berthold D, Tawadros T, Meuwly JY, Vallet V, et al. 50-Gy stereotactic body radiation therapy to the dominant Intraprostatic nodule: results from a phase 1a/b trial. Int J Radiat Oncol Biol Phys. 2019;103(2):320–34.
Article
PubMed
Google Scholar
Nicholls L, Suh YE, Chapman E, Henderson D, Jones C, Morrison K, et al. Stereotactic radiotherapy with focal boost for intermediate and high-risk prostate cancer: initial results of the SPARC trial. Clin Transl Radiat Oncol. 2020;25:88–93.
Article
PubMed
PubMed Central
Google Scholar
Timon G, Ciardo D, Bazani A, Marvaso G, Riva G, Volpe S, et al. Short-term high precision radiotherapy for early prostate cancer with concomitant boost to the dominant lesion: ad interim analysis and preliminary results of phase II trial AIRC-IG-13218. Br J Radiol. 2018;91(1089):20160725.
Article
PubMed
Google Scholar
Zelefsky MJ, Kollmeier M, McBride S, Varghese M, Mychalczak B, Gewanter R, et al. Five-year outcomes of a phase 1 dose-escalation study using stereotactic body radiosurgery for patients with Low-risk and intermediate-risk prostate Cancer. Int J Radiat Oncol Biol Phys. 2019;104(1):42–9.
Article
PubMed
PubMed Central
Google Scholar
Fairchild AT, Tanksley JP, Tenenbaum JD, Palta M, Hong JC. Interrater reliability in toxicity identification: limitations of current standards. Int J Radiat Oncol Biol Phys. 2020;107(5):996–1000.
Article
PubMed
Google Scholar
Zamboglou C, Spohn SKB, Adebahr S, Huber M, Kirste S, Sprave T, et al. PSMA-PET/MRI-based focal dose escalation in patients with primary prostate Cancer treated with stereotactic body radiation therapy (HypoFocal-SBRT): study protocol of a randomized, multicentric phase III trial. Cancers. 2021;13(22):5795.
Article
PubMed
PubMed Central
Google Scholar