LUNAR: a randomized Phase 2 study of 177Lutetium‐PSMA Neoadjuvant to Ablative Radiotherapy for Oligorecurrent Prostate Cancer (clinical trial protocol)

To assess the efficacy of 177Lu‐PNT2002, a novel radiolabelled small molecule that binds with high affinity to prostate‐specific membrane antigen (PSMA), in combination with stereotactic body radiotherapy (SBRT) to all sites of metastasis, vs SBRT alone, in men with oligorecurrent metastatic hormone‐sensitive prostate cancer (mHSPC).

[1]  K. Pienta,et al.  Long-Term Outcomes and Genetic Predictors of Response to Metastasis-Directed Therapy Versus Observation in Oligometastatic Prostate Cancer: Analysis of STOMP and ORIOLE Trials , 2022, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[2]  Christopher U. Jones,et al.  Local Failure Events in Prostate Cancer Treated with Radiotherapy: A Pooled Analysis of 18 Randomized Trials from the Meta-analysis of Randomized Trials in Cancer of the Prostate Consortium (LEVIATHAN). , 2022, European urology.

[3]  Hao Wang,et al.  Definitions of disease burden across the spectrum of metastatic castration-sensitive prostate cancer: comparison by disease outcomes and genomics , 2022, Prostate Cancer and Prostatic Diseases.

[4]  Xiaoyuan Chen,et al.  Prostate-Specific Membrane Antigen Radioligand Therapy Using 177Lu-PSMA I&T and 177Lu-PSMA-617 in Patients with Metastatic Castration-Resistant Prostate Cancer: Comparison of Safety, Biodistribution, and Dosimetry , 2021, The Journal of Nuclear Medicine.

[5]  N. Magné,et al.  OLIGOPELVIS GETUG P07, a Multicenter Phase II Trial of Combined High-dose Salvage Radiotherapy and Hormone Therapy in Oligorecurrent Pelvic Node Relapses in Prostate Cancer. , 2021, European urology.

[6]  K. Rahbar,et al.  Lutetium-177-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer. , 2021, The New England journal of medicine.

[7]  R. Bristow,et al.  Curative-intent Metastasis-directed Therapies for Molecularly-defined Oligorecurrent Prostate Cancer: A Prospective Phase II Trial Testing the Oligometastasis Hypothesis. , 2021, European urology.

[8]  A. Kishan,et al.  The Mutational Landscape of Metastatic Castration-sensitive Prostate Cancer: The Spectrum Theory Revisited , 2021, European urology.

[9]  Sean S. Park,et al.  Patterns of recurrence and modes of progression after metastasis-directed therapy in oligometastatic castration-sensitive prostate cancer , 2020, International journal of radiation oncology, biology, physics.

[10]  K. Tabata,et al.  Prognostic Value of the LATITUDE and CHAARTED Risk Criteria for Predicting the Survival of Men with Bone Metastatic Hormone-Naïve Prostate Cancer Treated with Combined Androgen Blockade Therapy: Real-World Data from a Japanese Multi-Institutional Study , 2020, BioMed research international.

[11]  B. Yaremko,et al.  Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of Oligometastatic Cancers: Long-Term Results of the SABR-COMET Phase II Randomized Trial , 2020, medRxiv.

[12]  Ash A. Alizadeh,et al.  Outcomes of Observation vs Stereotactic Ablative Radiation for Oligometastatic Prostate Cancer , 2020, JAMA oncology.

[13]  Versione,et al.  Common Terminology Criteria for Adverse Events , 2020, Definitions.

[14]  L. Collette,et al.  Characterisation and classification of oligometastatic disease: a European Society for Radiotherapy and Oncology and European Organisation for Research and Treatment of Cancer consensus recommendation. , 2020, The Lancet. Oncology.

[15]  M. Parmar,et al.  Abiraterone in "High-" and "Low-risk" Metastatic Hormone-sensitive Prostate Cancer. , 2019, European urology.

[16]  K. Pienta,et al.  Radiation Therapy in the Definitive Management of Oligometastatic Prostate Cancer: The Johns Hopkins Experience , 2019, International journal of radiation oncology, biology, physics.

[17]  E. Schaeffer,et al.  Oligometastatic Prostate Cancer: A Shrinking Subset or an Opportunity for Cure? , 2019, American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting.

[18]  M. Pomper,et al.  Imaging of Prostate-Specific Membrane Antigen with Small-Molecule PET Radiotracers: From the Bench to Advanced Clinical Applications. , 2019, Annual review of medicine.

[19]  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.

[20]  Yong-il Kim,et al.  Therapeutic Responses and Survival Effects of 177Lu-PSMA-617 Radioligand Therapy in Metastatic Castrate-Resistant Prostate Cancer: A Meta-analysis , 2018, Clinical nuclear medicine.

[21]  N. Lawrentschuk,et al.  Stereotactic Abative Body Radiotherapy (SABR) for Oligometastatic Prostate Cancer: A Prospective Clinical Trial. , 2018, European urology.

[22]  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.

[23]  Y. Park,et al.  Abiraterone plus Prednisone in Metastatic, Castration‐Sensitive Prostate Cancer , 2017, The New England journal of medicine.

[24]  W. Brenner,et al.  German Multicenter Study Investigating 177Lu-PSMA-617 Radioligand Therapy in Advanced Prostate Cancer Patients , 2017, Journal of Nuclear Medicine.

[25]  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.

[26]  I Syndikus,et al.  Alpha emitter radium-223 and survival in metastatic prostate cancer. , 2013, The New England journal of medicine.

[27]  M. Schell,et al.  Stereotactic body radiation therapy: the report of AAPM Task Group 101. , 2010, Medical physics.

[28]  A. Costello,et al.  Fractionated stereotactic body radiotherapy for up to five prostate cancer oligometastases: Interim outcomes of a prospective clinical trial , 2019, International journal of cancer.

[29]  T. Derlin,et al.  Patterns of Progression After 68Ga-PSMA-Ligand PET/CT-Guided Radiation Therapy for Recurrent Prostate Cancer. , 2019, International journal of radiation oncology, biology, physics.

[30]  F. Saad,et al.  Enzalutamide in Metastatic Prostate Cancer before Chemotherapy , 2014 .