A dose-response relationship for radiation in the management of prostate cancer is well established. Local recurrence of prostate cancer after external beam radiotherapy occurs in at least 40% of patients treated because of inability to deliver sufficient dose through external beam techniques. These patients respond well to re-irradiation using brachytherapy with about 50% of selected patients remaining free of recurrence 5 years after salvage. Advanced imaging using multiparametric Magnetic Resonance Imaging (mpMRI) allows identification of the site of recurrence, permitting partial prostate salvage brachytherapy. There is extensive literature on Low Dose Rate salvage brachytherapy but less on High Dose Rate.
Appropriately selected patients with histologically documented recurrence 3 years or more after initial external beam radiotherapy will undergo mpMRI for identification of the site of recurrence. A planning transrectal ultrasound (TRUS) will be obtained for fusion with the mpMRI and transposition of the target volume (GTV=gross tumor volume). A margin of 4.5 cm will be added to the GTV to create a focal planning target volume (PTV). The margin may be cropped at the interface with critical organs. Two fractions of HDR brachytherapy will be delivered, each from a single implant, 2 weeks apart. Following treatment patients will be monitored for toxicity and quality of life using the Expanded Prostate cancer Index (EPIC) questionnaire as well as the International Prostate Symptom score. Efficacy will be evaluated by monitoring the Prostate Specific Antigen (PSA) and if PSA is rising during follow-up, PSMA PET will be ordered when clinically indicated..
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
temporary radioactive implant
BCCA Center for the Southern Interior
Kelowna, British Columbia, Canada
RECRUITINGLate adverse gastrointestinal or genitourinary events grade 3 or higher
Common Terminology Criteria for Adverse Events (CTCAE V4.0)
Time frame: 3-60 months
Late Quality of Life
Expanded Prostate Cancer Index (EPIC)
Time frame: 3-60 months
Late lower urinary tract symptoms
International Prostate Symptom Score
Time frame: 3-60 months
Acute grade 3 or higher gastrointestinal or genitourinary adverse events
Common Terminology Criteria for Adverse Events (CTCAE V4.0)
Time frame: 0-3 months
Acute Quality of Life changes
Expanded Prostate Cancer Index (EPIC)
Time frame: 0-3 months
Acute lower urinary symptoms
International Prostate Symptoms Score
Time frame: 0-3 months
Biochemical disease free survival
PSA \< 0.4 ng/ml at 60 months
Time frame: 60 months
Number of participants with site of failure determined by PSMA PET Scan at the time of rising PSA.
Number of participants with site of failure determined by PSMA PET Scan at the time of rising PSA.
Time frame: 2 years
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