UpFrontPSMA: a randomized phase 2 study of sequential 177Lu‐PSMA‐617 and docetaxel vs docetaxel in metastatic hormone‐naïve prostate cancer (clinical trial protocol)

To assess the activity and safety of sequential lutetium‐177 (177Lu)‐PSMA‐617 and docetaxel vs docetaxel on a background of androgen deprivation therapy (ADT) in men with de novo metastatic hormone‐naïve prostate cancer (mHNPC).

[1]  M. Stockler,et al.  [177Lu]Lu-PSMA-617 versus cabazitaxel in patients with metastatic castration-resistant prostate cancer (TheraP): a randomised, open-label, phase 2 trial , 2021, The Lancet.

[2]  N. Lawrentschuk,et al.  Clinical Trial Protocol for LuTectomy: A Single-arm Study of the Dosimetry, Safety, and Potential Benefit of 177Lu-PSMA-617 Prior to Prostatectomy. , 2020, European urology focus.

[3]  H. G. van der Poel,et al.  Lutetium-177-PSMA-I&T as metastases directed therapy in oligometastatic hormone sensitive prostate cancer, a randomized controlled trial , 2020, BMC cancer.

[4]  D. Murphy,et al.  Prostate‐specific membrane antigen theranostics in advanced prostate cancer: an evolving option , 2020 .

[5]  N. Lawrentschuk,et al.  Prostate-specific membrane antigen PET-CT in patients with high-risk prostate cancer before curative-intent surgery or radiotherapy (proPSMA): a prospective, randomised, multicentre study , 2020, The Lancet.

[6]  D. Murphy,et al.  Prognostic biomarkers in men with metastatic castration-resistant prostate cancer receiving [177Lu]-PSMA-617 , 2020, European Journal of Nuclear Medicine and Molecular Imaging.

[7]  N. Lawrentschuk,et al.  Indirect Comparisons of Efficacy between Combination Approaches in Metastatic Hormone-sensitive Prostate Cancer: A Systematic Review and Network Meta-analysis. , 2020, European urology.

[8]  D. Murphy,et al.  Long-Term Follow-up and Outcomes of Retreatment in an Expanded 50-Patient Single-Center Phase II Prospective Trial of 177Lu-PSMA-617 Theranostics in Metastatic Castration-Resistant Prostate Cancer , 2019, The Journal of Nuclear Medicine.

[9]  D. Murphy,et al.  Poor Outcomes for Patients with Metastatic Castration-resistant Prostate Cancer with Low Prostate-specific Membrane Antigen (PSMA) Expression Deemed Ineligible for 177Lu-labelled PSMA Radioligand Therapy. , 2019, European urology oncology.

[10]  M. Stockler,et al.  TheraP: a randomized phase 2 trial of 177Lu‐PSMA‐617 theranostic treatment vs cabazitaxel in progressive metastatic castration‐resistant prostate cancer (Clinical Trial Protocol ANZUP 1603) , 2019, BJU international.

[11]  F. Saad,et al.  Prostate-Specific Membrane Antigen Ligand Positron Emission Tomography in Men with Nonmetastatic Castration-Resistant Prostate Cancer , 2019, Clinical Cancer Research.

[12]  D. Murphy,et al.  Prostate-specific Membrane Antigen Across the Spectrum of Prostate Cancer: Detection, Surgery, and Theranostics. , 2019, European urology.

[13]  D. Murphy,et al.  Dosimetry of 177Lu-PSMA-617 in Metastatic Castration-Resistant Prostate Cancer: Correlations Between Pretherapeutic Imaging and Whole-Body Tumor Dosimetry with Treatment Outcomes , 2018, The Journal of Nuclear Medicine.

[14]  A. Jemal,et al.  Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries , 2018, CA: a cancer journal for clinicians.

[15]  D. Bailey,et al.  A prospective randomized multicentre study of the impact of gallium‐68 prostate‐specific membrane antigen (PSMA) PET/CT imaging for staging high‐risk prostate cancer prior to curative‐intent surgery or radiotherapy (proPSMA study): clinical trial protocol , 2018, BJU international.

[16]  David F Jarrard,et al.  Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer: Long-Term Survival Analysis of the Randomized Phase III E3805 CHAARTED Trial. , 2018, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[17]  Oliver Sartor,et al.  Trial Design and Objectives for Castration-Resistant Prostate Cancer: Updated Recommendations From the Prostate Cancer Clinical Trials Working Group 3. , 2016, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[18]  U. Haberkorn,et al.  PSMA-Targeted Radionuclide Therapy of Metastatic Castration-Resistant Prostate Cancer with 177Lu-Labeled PSMA-617 , 2016, The Journal of Nuclear Medicine.

[19]  M. Schwaiger,et al.  Systemic Radioligand Therapy with (177)Lu Labeled Prostate Specific Membrane Antigen Ligand for Imaging and Therapy in Patients with Metastatic Castration Resistant Prostate Cancer. , 2016, The Journal of urology.

[20]  K. Rahbar,et al.  Response and tolerability of a single dose of 177Lu-PSMA-DKFZ-617 in patients with metastatic castration-resistant prostate cancer: a multicenter retrospective analysis , 2016 .

[21]  R. Laing,et al.  Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial , 2016, The Lancet.

[22]  R. Fimmers,et al.  Therapeutic response and side effects of repeated radioligand therapy with 177Lu-PSMA-DKFZ-617 of castrate-resistant metastatic prostate cancer , 2016, Oncotarget.

[23]  R. Baum,et al.  177Lu-Labeled Prostate-Specific Membrane Antigen Radioligand Therapy of Metastatic Castration-Resistant Prostate Cancer: Safety and Efficacy , 2016, The Journal of Nuclear Medicine.

[24]  David F Jarrard,et al.  Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer. , 2015, The New England journal of medicine.

[25]  K. Rahbar,et al.  Early side effects and first results of radioligand therapy with 177Lu-DKFZ-617 PSMA of castrate-resistant metastatic prostate cancer: a two-centre study , 2015, EJNMMI Research.

[26]  Piergiorgio Cerello,et al.  WIDEN: A tool for medical image management in multicenter clinical trials , 2014, Clinical trials.

[27]  Donna L Berry,et al.  Intermittent versus continuous androgen deprivation in prostate cancer. , 2013, The New England journal of medicine.

[28]  W. Heston,et al.  Tumor target prostate specific membrane antigen (PSMA) and its regulation in prostate cancer , 2004, Journal of cellular biochemistry.

[29]  William C. Olson,et al.  The homodimer of prostate-specific membrane antigen is a functional target for cancer therapy , 2003, Proceedings of the National Academy of Sciences of the United States of America.

[30]  N. Bander,et al.  In vitro characterization of radiolabeled monoclonal antibodies specific for the extracellular domain of prostate-specific membrane antigen. , 2000, Cancer research.

[31]  R L Sokoloff,et al.  A dual‐monoclonal sandwich assay for prostate‐specific membrane antigen: Levels in tissues, seminal fluid and urine , 2000, The Prostate.

[32]  George L. Wright,et al.  Detection and characterization of the prostate‐specific membrane antigen (PSMA) in tissue extracts and body fluids , 1995, International journal of cancer.