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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).
Mendez, Lucas C; Dhar, Aneesh; Laidley, David; Moussa, Madeleine; Gomez, Jose A; Chin, Joseph; Lee, T-Y; Thiessen, Jonathan D; Hoover, Douglas; Surrey, Kathleen; Helou, Joelle; Velker, Vikram; Correa, Rohann J; D'Souza, David; Bayani, Jane; Bauman, Glenn.
Afiliación
  • Mendez LC; London Health Sciences Centre, London, Ontario, Canada.
  • Dhar A; Department of Oncology, Western University, London, Ontario, Canada.
  • Laidley D; London Health Sciences Centre, London, Ontario, Canada.
  • Moussa M; London Health Sciences Centre, London, Ontario, Canada.
  • Gomez JA; London Health Sciences Centre, London, Ontario, Canada.
  • Chin J; London Health Sciences Centre, London, Ontario, Canada.
  • Lee TY; London Health Sciences Centre, London, Ontario, Canada.
  • Thiessen JD; Lawson Health Research Institute, London, Ontario, Canada.
  • Hoover D; Lawson Health Research Institute, London, Ontario, Canada.
  • Surrey K; London Health Sciences Centre, London, Ontario, Canada.
  • Helou J; Department of Oncology, Western University, London, Ontario, Canada.
  • Velker V; Department of Medical Biophysics, Western University, London, Ontario, Canada.
  • Correa RJ; London Health Sciences Centre, London, Ontario, Canada.
  • D'Souza D; London Health Sciences Centre, London, Ontario, Canada.
  • Bayani J; Department of Oncology, Western University, London, Ontario, Canada.
  • Bauman G; London Health Sciences Centre, London, Ontario, Canada.
BMC Cancer ; 23(1): 362, 2023 Apr 20.
Article en En | MEDLINE | ID: mdl-37081426
ABSTRACT

BACKGROUND:

Isolated 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.

METHODS:

ROADSTER 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.

DISCUSSION:

ROADSTER 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 REGISTRATION NCT05230251 (ClinicalTrials.gov).
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias de la Próstata / Braquiterapia Tipo de estudio: Clinical_trials / Guideline Aspecto: Patient_preference Límite: Humans / Male Idioma: En Revista: BMC Cancer Asunto de la revista: NEOPLASIAS Año: 2023 Tipo del documento: Article País de afiliación: Canadá

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias de la Próstata / Braquiterapia Tipo de estudio: Clinical_trials / Guideline Aspecto: Patient_preference Límite: Humans / Male Idioma: En Revista: BMC Cancer Asunto de la revista: NEOPLASIAS Año: 2023 Tipo del documento: Article País de afiliación: Canadá