Prostate CancerSHARPNCT04861415
SBRT vs. Conventional Fractionation With HDR Boost for Prostate Cancer
A study testing Sterotactic Body Radiotherapy and Conventionally Fractionated Radiation in people with Prostate Cancer, run by Dr. Gerard Morton at 1 site in Canada.
Trial summary
Random assignment between SBRT and conventionally fractionated boost following HDR brachytherapy for prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Sterotactic Body Radiotherapy and Conventionally Fractionated Radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteCanada
- Study dates
- 23 Dec 2020to 23 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Gerard Morton, MD, FRCPC, 416-480-6100 ext. 6165
Merrylee McGuffin, MSc, MRT(T), 416-480-6100 ext. 85454, Merrylee.Mcguffin@sunnybrook.ca
About this study
Official title: A Randomized Feasibility Trial of Stereotactic Body Radiotherapy Versus Conventional Fractionation With High Dose-rate (HDR) Brachytherapy Boost for Prostate Cancer
Random assignment between SBRT and conventionally fractionated boost following HDR brachytherapy for prostate cancer.
Read the 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
- Conditions
- Prostate Cancer
- Being tested
- Sterotactic Body Radiotherapy, Conventionally Fractionated Radiation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sterotactic Body RadiotherapyRadiation
Also called SBRT
Hypofractionated stereotactic radiation treatment.
Conventionally Fractionated RadiationRadiation
External beam radiation therapy treatment
| Study group | Role | What they receive |
|---|---|---|
| Conventional Fractionated Radiation | Active comparator | * 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 Receives: Radiation: Conventionally Fractionated Radiation |
| Stereotactic Body Radiotherapy | Experimental | * 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 Receives: Radiation: Sterotactic Body Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Feasibility
The proportion of patients accepting of being randomized divided by the number of patients approached for the study.
Measured: 18mo - 2 years
Secondary outcomes (10)
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.
Measured: 7 years
Treatment Toxicity
Proportion of patients with urinary, bowel and sexual Grade 2 and 3 toxicity measured by CTCAE v5.0 throughout the study period.
Measured: 7 years
Cumulative biochemical failure
Defined as the time of enrolment to biochemical failure (based on the Phoenix definition, PSA nadir plus 2)
Measured: 7 years
Overall Survival
Defined as time of enrollment to death from any cause
Measured: 7 years
Cancer Free Survival
Defined as time of enrolment to death attributed to prostate cancer
Measured: 7 years
Metastasis Free Survival
Defined as time of enrolment to development of metastasis or death from any cause
Measured: 7 years
Freedom From Local Failure
Defined as time of enrolment to first local recurrence
Measured: 7 years
Freedom From Regional Failure
Defined as time of enrolment to first regional recurrence
Measured: 7 years
ADT Free Survival
Defined as time of enrolment to salvage ADT use or death from any cause
Measured: 7 Years
PSA nadir
PSA nadir at 4-years post treatment
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start23 Dec 2020
- Primary completion23 Jun 2023 (estimated)
- Study completion23 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Gerard Morton
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Gerard Morton, Sunnybrook Health Sciences Centre
- Investigators
- Gerard Morton, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861415
- Sponsor's protocol ID
- 2734
- Acronym
- SHARP
- Status last verified
- Apr 2023
- First submitted
- 22 Apr 2021
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Feasibility Trial of Stereotactic Body Radiotherapy Versus Conventional Fractionation With High Dose-rate (HDR) Brachytherapy Boost for Prostate Cancer
- ClinicalTrials.gov ID
- NCT04861415
- Acronym / sponsor ID
- SHARP / 2734
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Dr. Gerard MortonUniversity, hospital or other
- Study start
- 23 Dec 2020 (actual)
- Primary completion
- 23 Jun 2023 (estimated)
- Study completion
- 23 Dec 2027 (estimated)
- First posted
- 27 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Fractionated Radiation | Active comparator | Radiation: Conventionally Fractionated Radiation* 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 |
| Stereotactic Body Radiotherapy | Experimental | Radiation: Sterotactic Body Radiotherapy* 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sterotactic Body RadiotherapyAlso: SBRTHypofractionated stereotactic radiation treatment. | Radiation | Stereotactic Body Radiotherapy |
| Conventionally Fractionated RadiationExternal beam radiation therapy treatment | Radiation | Conventional Fractionated Radiation |
Primary outcome
Treatment Feasibility
Time frame: 18mo - 2 years
The proportion of patients accepting of being randomized divided by the number of patients approached for the study.
10 secondary outcomes
QOL
Time frame: 7 years
Treatment Toxicity
Time frame: 7 years
Cumulative biochemical failure
Time frame: 7 years
Overall Survival
Time frame: 7 years
Cancer Free Survival
Time frame: 7 years
Metastasis Free Survival
Time frame: 7 years
Freedom From Local Failure
Time frame: 7 years
Freedom From Regional Failure
Time frame: 7 years
ADT Free Survival
Time frame: 7 Years
PSA nadir
Time frame: 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gerard Morton principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sterotactic Body Radiotherapy and Conventionally Fractionated Radiation in people with Prostate Cancer, run by Dr. Gerard Morton at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gerard Morton, MD (416-480-6100 ext. 6165, gerard.morton@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Feasibility (time frame: 18mo - 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.