NCT Number: NCT04861415
Random assignment between SBRT and conventionally fractionated boost following HDR brachytherapy for prostate cancer.
Interested in participating?
Request Info18 year and older
Male
Interventional
Not applicable
Toronto, Ontario, M4N 3M5, Canada
Location status: Recruiting
Gerard Morton, MD, FRCPC
CONTACT
416-480-6100 ext. 6165
Mark Corkum
PRINCIPAL_INVESTIGATOR
Merrylee McGuffin, MSc, MRT(T)
CONTACT
416-480-6100 ext. 85454
Many treatment options exist for prostate cancer. One common treatment approach is to combine high-dose rate (HDR) brachytherapy (temporary insertion of radiation into the prostate) and external beam radiation. External beam radiation typically requires daily radiation treatment for three to five weeks. Improvements to radiation planning and delivery has allowed stereotactic body radiation therapy (SBRT) to be implemented in many types of cancer. SBRT has been implemented as a standard treatment option after HDR brachytherapy in response to the COVID pandemic. We are seeking to evaluate whether it is feasible to randomly assign men between SBRT (which will be five treatments of radiation or conventional radiation (3-5 weeks of daily treatment) following HDR brachytherapy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Hypofractionated stereotactic radiation treatment.
Other names: SBRT
External beam radiation therapy treatment
Time frame: 18mo - 2 years
The proportion of patients accepting of being randomized divided by the number of patients approached for the study.
Time frame: 7 years
Urinary, bowel and sexual health-related quality of life measured by the Expanded Prostate Cancer Index Composite (EPIC) domains over the study period. Each domain is normalized from 0 to 100, with a higher score indicating better outcome.
Time frame: 7 years
Proportion of patients with urinary, bowel and sexual Grade 2 and 3 toxicity measured by CTCAE v5.0 throughout the study period.
Time frame: 7 years
Defined as the time of enrolment to biochemical failure (based on the Phoenix definition, PSA nadir plus 2)
Time frame: 7 years
Defined as time of enrollment to death from any cause
Time frame: 7 years
Defined as time of enrolment to death attributed to prostate cancer
Time frame: 7 years
Defined as time of enrolment to development of metastasis or death from any cause
Time frame: 7 years
Defined as time of enrolment to first local recurrence
Time frame: 7 years
Defined as time of enrolment to first regional recurrence
Time frame: 7 Years
Defined as time of enrolment to salvage ADT use or death from any cause
Time frame: 6 years
PSA nadir at 4-years post treatment
Contact information is provided by the study sponsor or research team.
Dr. Gerard Morton
Other
A Randomized Feasibility Trial of Stereotactic Body Radiotherapy Versus Conventional Fractionation With High Dose-rate (HDR) Brachytherapy Boost for Prostate Cancer
Acronym: SHARP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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