Patients with unfavorable intermediate-risk prostate cancer will be randomized between 6 versus 12 months of hormone therapy with radiation therapy. Patients may choose to receive hypofractionated radiation therapy or hypofractionated radiation therapy with high-dose rate brachytherapy. Hypofractionated radiation therapy refers to radiation therapy given fewer treatments, however higher doses per treatment.
A total of 400 patients with unfavorable intermediate-risk prostate cancer will be randomized into 2 arms: The first arm will receive the standard 6-month duration of hormone therapy with concomitant radiation therapy. The second arm will receive 12 months with concomitant radiation therapy. Radiation treatment will consist of either concomitant prostate SBRT to a dose of 40 Gy/5fractions over 2 weeks or a combination of external beam radiotherapy dose of 25 Gy in 5 fractions with a high-dose rate brachytherapy boost of 15 Gy. The choice of radiation treatment will be to the investigator's discretion..Patients will be stratified according to the number of intermediate-risk factors and according to the radiation therapy type.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
Total of two 3-month injections of a LHRH agonist for total duration of 6 months
Total of four 3-month injections of a LHRH agonist for total duration of 12 months
Patients may receive prostate stereotactic body radiation therapy or a combination of high-dose rate brachytherapy with radiation therapy; as per the treating physician's preference
Hôpital de Gatineau
Gatineau, Quebec, Canada
Hôpital Charles LeMoyne
Longueuil, Quebec, Canada
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
biochemical progression-free survival
rate of survival without a biochemical relapse. The definition of biochemical relapse is the PSA nadir + 2. The rates of biochemical relapse will be compared between the patients receiving 6 months vs 12 months of hormonal therapy.
Time frame: 5 years
overall survival
rate of survival (death due to any cause)
Time frame: 5 years
biochemical progression-free survival
rate of survival without a biochemical relapse. The definition of biochemical relapse is the PSA nadir + 2. The rates of biochemical relapse will be compared between patients receiving stereotactic body radiation therapy (SBRT) vs hypofractionated radiation therapy with high-dose rate brachytherapy.
Time frame: 5 years
disease-specific survival
compare death rates due to prostate cancer between patients that received 6 months of hormone therapy versus those that received 12 months of hormone therapy.
Time frame: 5 years
CTCAE version 5 acute and late toxicity
Acute and delayed toxicity differences measured by CTCAE version 5, at or before 90 days for the acute and 90-180 days and after for the delayed toxicity.
Time frame: 5 years
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Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada