This study is being done to answer the following question: Is the strategy to give higher doses of radiotherapy treatment over a shorter period of time using special equipment and fewer treatments (also known as Stereotactic Body Radiation Therapy or SBRT) as effective as usual external radiation therapy given with a brachytherapy boost (which involves radiation sources inserted directly into the prostate)?
The usual approach for patients with unfavourable prostate cancer who are not in a study is treatment with external beam radiation therapy (EBRT) to the pelvis and prostate in combination with hormone therapy (androgen deprivation therapy - ADT). To improve control of prostate cancer at risk of returning, additional treatment with a brachytherapy boost (insertion of radiation sources directly into the prostate) is recommended. For patients who get the usual approach for this cancer, about 89 out of 100 are free of cancer after 5 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
710
46Gy / 23 fractions of EBRT to pelvis and prostate + LDR or HDR boost to prostate OR 25Gy / 5 fractions of EBRT to pelvis and prostate (ultrahypofractionation EBRT (SBRT)) + LDR or HDR boost to prostate. \+ Adjuvant ADT: Unfavourable Intermediate Risk: 6 months or High / Very High Risk: 24 months
25Gy / 5 fractions to pelvis + 40 Gy / 5 fractions to prostate (SBRT) (ultrahypofractionation EBRT (SBRT))
Assigned at enrollment
To compare the progression-free survival (PFS) of SBRT versus conventional EBRT plus brachytherapy boost defined as time to biochemical failure, initiation of salvage therapy, local-regional recurrence, distant progression, or death
Time frame: 8.6 years
Safety and tolerability assessed by CTCAE v5.0
Time frame: 8.6 years
PSA response at 4 years compared using a Cochran-Mantel-Haenszel (CMH) test
Time frame: 8.6 years
Metastasis-free Survival compared using the Gray's test
Time frame: 8.6 years
Cause-specific Survival compared using the Gray's test
Time frame: 8.6 years
Overall Survival analysed using a Cox proportional hazards model and graphically described using the Kaplan-Meier method
Time frame: 8.6 years
Participant-reported outcomes using EPIC-26 questionnaire
Time frame: 8.6 years
Participant-reported tolerability using PRO-CTCAE questionnaire
Time frame: 8.6 years
Economic Outcomes using EQ-5D-5L
Canadian sites only
Time frame: 8.6 years
Economic Outcomes using FACIT-COST
Canadian sites only
Time frame: 8.6 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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