This phase 3 trial is examining the effectiveness and safety of low dose rate (LDR) vs high dose rate (HDR) prostate brachytherapy (BT)for patients with prostate cancer (PC). The main outcome to be measured will be the quality of life in terms of urinary symptoms. This trial is recruiting in British Columbia, Canada.
The details
A treatment option for patients with favorable or intermediate-risk PC is with brachytherapy (a procedure that involves placing radioactive material inside the body to kill the cancer cells). It is not known if one dose of LDR therapy or 2 doses of HDR therapy is more effective at treating these patients.
This study is being done to investigate the effectiveness and safety of low dose rate (LDR) vs high dose rate (HDR) prostate BT for patients with favorable and intermediate-risk PC. The main outcome to be measured will be the quality of life in terms of urinary symptoms after 36 months.
Who are they looking for?
140 participants with favorable or intermediate-risk PC will be recruited. Patients must have a life expectancy of at least 10 years, a PSA (protein in the blood that increases in PC) level lower than 20 and a Gleason score (a measure for the aggressiveness of PC) lower than 8. Patients must not have had androgen deprivation therapy (ADT; hormonal therapy), and have a prostate volume of 60 ccs or less.
Patients cannot participate if they have had radical surgery for prostate carcinoma, pelvic radiation, prostate chemotherapy, cryotherapy or cannot have an MRI (imaging test).
How will it work
There will be two groups. Group 1 will receive one session of LDR brachytherapy with MRI imaging 4 weeks later. Group 2 will receive HDR brachytherapy in two procedures four weeks apart with no follow-up MRI imaging.
Patients will be followed up for 36 months for the quality of life and up to 10 years for side effects and recurrence.
