The use of Lutetium-177 PSMA radioligand therapy with high dose rate brachytherapy for locally recurrent prostate cancer after previous definitive radiation therapy: a randomized, single-institution, phase I/II study (ROADSTER).

BMC Cancer

Study Protocol

T-Y Lee¹  Jonathan D. Thiessen¹  Jose A. Gomez²  Madeleine Moussa²  Aneesh Dhar²  David Laidley²  Joseph Chin²  Kathleen Surrey²  David D’Souza³  Rohann J. Correa³  Vikram Velker³  Joelle Helou³  Lucas C. Mendez³  Douglas Hoover⁴  Glenn Bauman⁵  Jane Bayani⁶ 

[1]Lawson Health Research Institute, London, Ontario, Canada

[2]London Health Sciences Centre, London, Ontario, Canada

[3]London Health Sciences Centre, London, Ontario, Canada

[4]Department of Oncology, Western University, London, Ontario, Canada

[5]London Health Sciences Centre, London, Ontario, Canada

[6]Department of Oncology, Western University, London, Ontario, Canada

[7]Department of Medical Biophysics, Western University, London, Ontario, Canada

[8]London Health Sciences Centre, London, Ontario, Canada

[9]Lawson Health Research Institute, London, Ontario, Canada

[10]Department of Oncology, Western University, London, Ontario, Canada

[11]Ontario Institute for Cancer Research, Toronto, Ontario, Canada

关键词: Prostate Cancer;    Isolated Local Failure;    Radiorecurrent Prostate Cancer;    High Dose Rate Brachytherapy;    Lutetium-177;    Prostate Specific Membrane Antigen;    Positron Emission Tomography;    Radioligand Therapy;   

DOI  :  10.1186/s12885-023-10851-0

 received in 2022-12-02, accepted in 2023-04-14,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundIsolated local failure (ILF) can occur in patients who initially receive definitive radiation therapy for prostate cancer. Salvage therapy for ILF includes high dose rate (HDR) brachytherapy. Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) can accurately detect ILF and can exclude extraprostatic disease. Lutetium-177 PSMA Radioligand Therapy (RLT) is a novel treatment for prostate cancer that can target prostate cancer accurately, while sparing radiation dose to normal tissues.MethodsROADSTER is a phase I/II randomized, single-institution study. Patients with an ILF of prostate cancer after definitive initial radiation therapy are eligible. The ILF will be confirmed with biopsy, magnetic resonance imaging (MRI) and PSMA PET. Patients will be randomized between HDR brachytherapy in two fractions (a standard of care salvage treatment at our institution) (cohort 1) or one treatment of intravenous Lutetium-177 PSMA RLT, followed by one fraction of HDR brachytherapy (cohort 2). The primary endpoints for the phase I portion of the study (n = 12) will be feasibility, defined as 10 or more patients completing the study protocol within 24 months of study activation; and safety, defined as zero or one patients in cohort 2 experiencing grade 3 or higher toxicity in the first 6 months post-treatment. If feasibility and safety are achieved, the study will expand to a phase II study (n = 30 total) where preliminary efficacy data will be evaluated. Secondary endpoints include changes in prostate specific antigen levels, acute toxicity, changes in quality of life, and changes in translational biomarkers. Translational endpoints will include interrogation of blood, urine, and tissue for markers of DNA damage and immune activation with each treatment.DiscussionROADSTER explores a novel salvage therapy for ILF after primary radiotherapy with combined Lutetium-177 PSMA RLT and HDR brachytherapy. The randomized phase I/II design will provide a contemporaneous patient population treated with HDR alone to facilitate assessment of feasibility, tolerability, and biologic effects of this novel therapy.Trial registrationNCT05230251 (ClinicalTrials.gov).

【 授权许可】

CC BY   
© The Author(s) 2023

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