Trial Evaluating the Safety and Efficacy Of MR-Linac-Guided Radiotherapy as Salvage Treatment After External Beam Radiotherapy Recurrence (TUMORNATOR II)
The purpose of this study is to assess the impact of prostate-specific membrane antigen/positron emission tomography (PSMA/PET)-informed magnetic resonance (MR)-guided radiation therapy on serious toxicity outcomes in patients with biopsy-proven locally radiorecurrent prostate cancer. The primary aim is to evaluate the safety of delivering MR-Linac-guided stereotactic body radiotherapy (SBRT) after prior prostate external beam radiotherapy for recurrent disease, and assess urinary toxicity outcomes at 2 years.
• 18 years of age or older male participants
• Biopsy proven intraprostatic prostate cancer after prior definitive external beam radiotherapy (moderate hypofractionation or Stereotactic Body Radiation Therapy (SBRT) acceptable).
• a. NOTE: Seminal vesicle involvement allowed
• Pathology confirming recurrent disease must have evidence of viable cancer as indicated with pathology interpretation where a Gleason score can be assigned
• Serum testosterone ≥ 50 ng/dL determined within 2 months prior to enrollment
• a. Prior Androgen Deprivation Therapy (ADT) use acceptable if testosterone level \>50ng/dL
• At least 4 weeks must have elapsed from major surgery
• Karnofsky Performance Scale (KPS) ≥ 80% or Eastern Cooperative Oncology Group (ECOG) 0-1
• Prostate size as determined on MRI to be \< 90 cc.
• International Prostatism Symptom Score (IPSS) ≤ 20
• Patient must be available for follow-up. After 2 years of follow-up, upon completion of post-treatment biopsy, telephone, and chart review-based follow-up will be acceptable for up to 5 years
⁃ Presence of a T2 and/or DWI-visible prostatic lesion on mpMRI
⁃ a. NOTE: Lesion visible on MRI required for enrollment but PSMA/PET avid lesion not required
⁃ Satisfy all MRI screening criteria and be willing to fill out the standard MRI screening form