RAdiation Dose TAiloRing Guided by Enhanced Targeting
This is a phase II non-blinded randomized controlled trial of image-guided, tumor-focused radiotherapy in patients with intermediate- or high-risk prostate cancer planning to undergo definitive radiotherapy with or without systemic therapy. The image-guided, tumor-focused radiotherapy will be compared to standard, whole-prostate treatment. The investigators hypothesize that tumor-focused radiotherapy reduces the radiation dose to organs close to the prostate, possibly leading to decreased acute toxicity to the genitourinary and gastrointestinal organs. The investigators will measure acute and late genitourinary and gastrointestinal toxicity due to radiation and regardless of cause. The investigators will also measure overall survival, metastasis-free survival, and quality of life, as well as biomarkers that may help predict, in the future, who may have a worse toxicity following radiation therapy.
• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• At least 18 years old
• Histologic confirmation of prostate adenocarcinoma with plan for curative-intent radiation therapy
• Lesion visible on prostate Magnetic Resonance Imaging and/or Prostate-Specific Membrane Antigen Positron Emission Tomography-Computed Tomography (according to the treating physician) with concordant pathology from biopsy needle locations.
• For participants able to cause a pregnancy: use of condoms or other methods to ensure effective contraception with partner during the radiation therapy treatment and for at least 6 months afterward.