Back to resultsSBRT vs. Conventional Fractionation With HDR Boost for Prostate Cancer (SHARP)
Primary Purpose
Prostate Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Sterotactic Body Radiotherapy
Conventionally Fractionated Radiation
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- Age 18 or older
- Informed consent for treatment and study participation completed
- Pathologically proven diagnosis of prostate adenocarcinoma
- ECOG Performance Status 0-2
- No prior history of pelvic radiotherapy, brachytherapy, cryosurgery, HIFU, TURP or radical prostatectomy
Exclusion Criteria:
- Presence of nodal or distant metastasis on staging MRI or CT Abdomen/Pelvis and Bone scan within 90 days of enrolment (CT/MRI/Bone Scan are only required if the clinical risk of metastatic disease is sufficient to warrant these scans)
- Plan for adjuvant chemotherapy post-radiotherapy
- Serious medical comorbidities or other contraindications to HDR brachytherapy
- Presence of inflammatory bowel disease
- Presence of connective tissue disorder seen as a contraindication to radiotherapy
- Medically unfit for general/spinal anesthesia
- Unable or unwilling to complete questionnaires
Sites / Locations
- Sunnybrook Health Sciences CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional Fractionated Radiation
Stereotactic Body Radiotherapy
Arm Description
Prostate Only Radiation - 37.5Gy in 15 daily fractions to the prostate and proximal/entire seminal vesicle Prostate + Nodal Radiation - 46Gy in 23 daily fractions to the prostate, seminal vesicle and regional lymph nodes
Prostate Only Radiation - 25Gy in 5 fractions to the prostate and proximal/entire seminal vesicle Prostate + Nodal Radiation - 25Gy in 5 fractions to the prostate, seminal vesicle and regional lymph nodes
Outcomes
Primary Outcome Measures
Treatment Feasibility
The proportion of patients accepting of being randomized divided by the number of patients approached for the study.
Secondary Outcome Measures
QOL
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.
Treatment Toxicity
Proportion of patients with urinary, bowel and sexual Grade 2 and 3 toxicity measured by CTCAE v5.0 throughout the study period.
Cumulative biochemical failure
Defined as the time of enrolment to biochemical failure (based on the Phoenix definition, PSA nadir plus 2)
Overall Survival
Defined as time of enrollment to death from any cause
Cancer Free Survival
Defined as time of enrolment to death attributed to prostate cancer
Metastasis Free Survival
Defined as time of enrolment to development of metastasis or death from any cause
Freedom From Local Failure
Defined as time of enrolment to first local recurrence
Freedom From Regional Failure
Defined as time of enrolment to first regional recurrence
ADT Free Survival
Defined as time of enrolment to salvage ADT use or death from any cause
PSA nadir
PSA nadir at 4-years post treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04861415
Brief Title
SBRT vs. Conventional Fractionation With HDR Boost for Prostate Cancer
Acronym
SHARP
Official Title
A Randomized Feasibility Trial of Stereotactic Body Radiotherapy Versus Conventional Fractionation With High Dose-rate (HDR) Brachytherapy Boost for Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 23, 2020 (Actual)
Primary Completion Date
June 23, 2023 (Anticipated)
Study Completion Date
December 23, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Gerard Morton
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Random assignment between SBRT and conventionally fractionated boost following HDR brachytherapy for prostate cancer.
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional Fractionated Radiation
Arm Type
Active Comparator
Arm Description
Prostate Only Radiation - 37.5Gy in 15 daily fractions to the prostate and proximal/entire seminal vesicle
Prostate + Nodal Radiation - 46Gy in 23 daily fractions to the prostate, seminal vesicle and regional lymph nodes
Arm Title
Stereotactic Body Radiotherapy
Arm Type
Experimental
Arm Description
Prostate Only Radiation - 25Gy in 5 fractions to the prostate and proximal/entire seminal vesicle
Prostate + Nodal Radiation - 25Gy in 5 fractions to the prostate, seminal vesicle and regional lymph nodes
Intervention Type
Radiation
Intervention Name(s)
Sterotactic Body Radiotherapy
Other Intervention Name(s)
SBRT
Intervention Description
Hypofractionated stereotactic radiation treatment.
Intervention Type
Radiation
Intervention Name(s)
Conventionally Fractionated Radiation
Intervention Description
External beam radiation therapy treatment
Primary Outcome Measure Information:
Title
Treatment Feasibility
Description
The proportion of patients accepting of being randomized divided by the number of patients approached for the study.
Time Frame
18mo - 2 years
Secondary Outcome Measure Information:
Title
QOL
Description
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
Title
Treatment Toxicity
Description
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
Title
Cumulative biochemical failure
Description
Defined as the time of enrolment to biochemical failure (based on the Phoenix definition, PSA nadir plus 2)
Time Frame
7 years
Title
Overall Survival
Description
Defined as time of enrollment to death from any cause
Time Frame
7 years
Title
Cancer Free Survival
Description
Defined as time of enrolment to death attributed to prostate cancer
Time Frame
7 years
Title
Metastasis Free Survival
Description
Defined as time of enrolment to development of metastasis or death from any cause
Time Frame
7 years
Title
Freedom From Local Failure
Description
Defined as time of enrolment to first local recurrence
Time Frame
7 years
Title
Freedom From Regional Failure
Description
Defined as time of enrolment to first regional recurrence
Time Frame
7 years
Title
ADT Free Survival
Description
Defined as time of enrolment to salvage ADT use or death from any cause
Time Frame
7 Years
Title
PSA nadir
Description
PSA nadir at 4-years post treatment
Time Frame
6 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 or older
Informed consent for treatment and study participation completed
Pathologically proven diagnosis of prostate adenocarcinoma
ECOG Performance Status 0-2
No prior history of pelvic radiotherapy, brachytherapy, cryosurgery, HIFU, TURP or radical prostatectomy
Exclusion Criteria:
Presence of nodal or distant metastasis on staging MRI or CT Abdomen/Pelvis and Bone scan within 90 days of enrolment (CT/MRI/Bone Scan are only required if the clinical risk of metastatic disease is sufficient to warrant these scans)
Plan for adjuvant chemotherapy post-radiotherapy
Serious medical comorbidities or other contraindications to HDR brachytherapy
Presence of inflammatory bowel disease
Presence of connective tissue disorder seen as a contraindication to radiotherapy
Medically unfit for general/spinal anesthesia
Unable or unwilling to complete questionnaires
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gerard Morton, MD
Phone
416-480-6100
Ext
6165
Email
gerard.morton@sunnybrook.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Merrylee McGuffin
Phone
416-480-6100
Ext
85454
Email
Merrylee.Mcguffin@sunnybrook.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerard Morton
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerard Morton, MD, FRCPC
Phone
416-480-6100
Ext
6165
First Name & Middle Initial & Last Name & Degree
Merrylee McGuffin, MSc, MRT(T)
Phone
416-480-6100
Ext
85454
Email
Merrylee.Mcguffin@sunnybrook.ca
First Name & Middle Initial & Last Name & Degree
Mark Corkum
12. IPD Sharing Statement
Learn more about this trial
SBRT vs. Conventional Fractionation With HDR Boost for Prostate Cancer
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