Radical radiation therapy for prostate cancer is a common treatment that has shown to improve clinical outcomes in a post-operative setting. However, radiation therapy after surgery poses a greater risk for bladder and rectum injury for patients with prostate or bladder cancer. For prostate cancer patients, the risk is further amplified when pelvic nodes are part of the target irradiated volume. For bladder cancer patients, the risk of injury increases when more of the bladder is part of the target volume. Using an adaptive radiation therapy approach allows for correcting any shifts in the target volume. ART approach uses images from treatment to adapt the treatment plan. This study will use Adaptive Radiation Therapy for patients who receive pelvic nodal radiotherapy for either prostate or bladder cancer. Their treatment plans will adapted using MRI scans and CBCT scans taken during their first week of radiotherapy to account for any shifts in the target volume. The purpose of this study is to evaluate the feasibility of ART approach and its and on treatment plan quality metrics for pelvic radiotherapy. Acute and late toxicities will also be evaluated. 40 participants (minimum of 10 bladder cancer patients) will be enrolled. The participants will be followed for a period of 5 years post radiation therapy, during which they will have PSA as per standard practice, along with follow-up questionnaires (EPIC for prostate cancer patients and BUSS for bladder cancer patients).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Cone-beam CT images as well as MRI scans will be used to make any changes to the radiation treatment plan, part of the way through the treatment. Adaptation of treatment plans may allow smaller target volumes to be treated with higher doses, while minimizing the side effects to surrounding organs.
University Health Network, Princess Margaret Hospital
Toronto, Ontario, Canada
Dosimetry
Difference in dose-volume irradiation of critical organs between original and adapted plan will be compared.
Time frame: 5 years
Toxicity in Patients
To determine a preliminary measure of toxicity with this technique. CTCAE toxicity data will be described for this population.
Time frame: Before Radiation Therapy, and at Month 3, Year 1, 3 & 5 after Radiation Therapy
Bladder Cancer Patients' Quality of Life Function
Bladder Utility Symptom Scale (BUSS) questionnaires will be scored and analyzed to determine QoL function. BUSS will be scored (1-100) as per standard criteria. Data will be analyzed as a continuous variable
Time frame: Before Radiation Therapy, and at Month 3, Year 1, 3 & 5 after Radiation Therapy
Prostate Cancer Patients' Quality of Life Function
Expanded Prostate Cancer Index Composite (EPIC) questionnaires will be scored and analyzed to determine QoL function. EPIC will be scored (1-100) as per standard criteria. Data will be analyzed as a continuous variable
Time frame: Before Radiation Therapy, and at Month 3, Year 1, 3 & 5 after Radiation Therapy
Biochemical Control in Prostate Patients
For prostate patients, patients will be considered to have biochemical failure if the PSA has risen 2ng above nadir.
Time frame: PSA will be done before Radiation Therapy, and at Month 3, Year 1, 3 and 5 after Radiation Therapy
Local Control in Bladder Patients
Local control will be defined by an absence of clinically locally recurrent disease
Time frame: 5 years
Feasibility of the use of Fiducial markers for bladder RT: quality of target delineation using fiducial markers
Feasibility will be determined by analyzing the quality of target delineation using fiducial markers in bladder cancer patients.
Time frame: 5 years
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