Your session is about to expire
← Back to Search
Radiation Therapy
SBRT vs. Conventional Radiation for Prostate Cancer (SHARP Trial)
N/A
Recruiting
Led By Gerard Morton
Research Sponsored by Dr. Gerard Morton
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pathologically proven diagnosis of prostate adenocarcinoma
Age 18 or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18mo - 2 years
Awards & highlights
SHARP Trial Summary
This trial is testing whether a different way of giving radiation to prostate cancer patients is better than the standard way.
Who is the study for?
This trial is for adults over 18 with prostate cancer who haven't had previous treatments like pelvic radiotherapy, brachytherapy, or surgery. They should be relatively healthy and able to consent to treatment. People with metastatic disease, serious health issues that conflict with the treatment, inflammatory bowel disease, or certain connective tissue disorders can't join.Check my eligibility
What is being tested?
The study compares two types of radiation therapy for prostate cancer: Stereotactic Body Radiotherapy (SBRT) versus conventional fractionated radiation after HDR brachytherapy. Patients are randomly placed into one of these two groups.See study design
What are the potential side effects?
Potential side effects include skin reactions in the treated area, fatigue, urinary and bowel symptoms such as frequency or discomfort during urination and changes in bowel habits.
SHARP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with prostate cancer.
Select...
I am 18 years old or older.
Select...
I can take care of myself and am up and about more than half of the day.
Select...
I have never had treatments like radiation or surgery on my prostate.
SHARP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18mo - 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18mo - 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Treatment Feasibility
Secondary outcome measures
ADT Free Survival
Cancer Free Survival
Cumulative biochemical failure
+7 moreSHARP Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Stereotactic Body RadiotherapyExperimental Treatment1 Intervention
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
Group II: Conventional Fractionated RadiationActive Control1 Intervention
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
Find a Location
Who is running the clinical trial?
Dr. Gerard MortonLead Sponsor
Gerard MortonPrincipal InvestigatorSunnybrook Health Sciences Centre
1 Previous Clinical Trials
232 Total Patients Enrolled
1 Trials studying Prostate Cancer
232 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with prostate cancer.My scans show cancer has spread to my lymph nodes or other parts of my body.I am scheduled for chemotherapy after my radiotherapy.I have a connective tissue disorder that makes radiotherapy unsafe for me.I cannot or do not want to fill out questionnaires.I have inflammatory bowel disease.I cannot undergo surgery with general or spinal anesthesia due to health reasons.I am 18 years old or older.I can take care of myself and am up and about more than half of the day.I do not have serious health issues that prevent me from having HDR brachytherapy.I have never had treatments like radiation or surgery on my prostate.
Research Study Groups:
This trial has the following groups:- Group 1: Conventional Fractionated Radiation
- Group 2: Stereotactic Body Radiotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the scope of this research study in terms of participant numbers?
"Affirmative. Evidence found on clinicaltrials.gov displays that this study is presently enrolling participants, which commenced on December 23rd 2020 and was most recently updated on May 3rd 2022. For the full duration of the trial, 55 patients will be recruited from one centre."
Answered by AI
Is this medical research looking for new participants?
"Based on the information available from clinicaltrials.gov, enrollments for this study are ongoing since it was initially advertised in December 2020 and last updated in May 2022."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger