A randomized controlled open-label trial in patients with high risk prostate cancer. Eligible and consenting patients will be randomly allocated to receive stereotactic body radiotherapy (SBRT) boost to prostate or conventional radiotherapy boost to prostate in 1:1 ratio. Prostate radiotherapy boost will be administered after standard pelvic radiotherapy. Subjects will be followed for 24 months post radiation treatment for Quality of Life assessment and toxicity.
In this study we investigate stereotactic body radiotherapy (SBRT) as a boost radiotherapy treatment, following pelvic radiotherapy, in patients with high risk prostate cancer (PrCa) treated with Androgen Deprivation Therapy (ADT). One hundred patients with localized high risk PrCa will receive ADT for a total of 3 years. Three months after initiation of ADT all patients will receive pelvic (lymph node and prostate) treatment of 45Gy in 25 fractions (5 days per week). Then patients will be randomized to receive either The conventional radiotherapy (CRT) of 33 - 35 Gy in 16 fractions (5 days per week - over 22 days) (comparator arm) or SBRT boost treatment of 19.5 - 21 Gy in three fractions (1 treatment per week - over 22days) (experimental arm). SBRT boost treatment will be delivered with either cyberknife or VMAT technique.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Standard LHRH agonist for 3 years
Pelvic Radiation
SBRT: 19.5 - 21 Gy in three fractions (1 treatment per week - over 22days)
Juravinski Cancer Centre
Hamilton, Ontario, Canada
RECRUITINGWalker Family Cancer Centre ,Niagara Health - St. Catharines Site
St. Catharines, Ontario, Canada
RECRUITINGShort Term Quality of Life (QoL)
To compare early QoL (up to 6 months post RT) in patients with high risk adenocarcinoma of the prostate treated with ADT and RT in the form of pelvic nodal irradiation and prostate boost with standard fractionation, or pelvic nodal irradiation and prostate boost with SBRT using Cyberknife or VMAT. QoL, defined as bowel and bladder function and bother after PrCa treatment, will be measured prior to and at regular intervals after completion of radiotherapy using the established Prostate QoL (The Expanded Prostate cancer Index Composite (EPIC-26 instrument)). Higher EPIC score represent a better outcome
Time frame: up to 6 months post radiation
Long Term Quality of Life (QoL)
long term QoL QoL, defined as bowel and bladder function and bother after PrCa treatment, will be measured prior to and at regular intervals up to 24 months month after completion of radiotherapy using the established Prostate QoL (The Expanded Prostate cancer Index Composite (EPIC-26 instrument)). Higher EPIC score represent a better outcome
Time frame: 24 months
Urinary function assessment
short and long term quality of urinary function (The International Prostate Symptom Score (IPSS)). Total IPSS is between 1-35 / lower score shows better function.
Time frame: 24 months
Late Toxicity
Grade 2-4 treatment related late (12-24 months), bladder and bowel related toxicity evaluated by the Expanded Common Toxicity Criteria of the National Cancer Institute of Canada (NCI)
Time frame: 12-24 months
Theos Tsakiridis, Senior Principle Investigator, MD, FRCPC
CONTACT
Naghmeh Isfahanian, Junior Principle Investigator, MD, FRCPC
CONTACT
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CRT: 33 - 35 Gy in 16 fractions (5 days per week - over 22 days)