Prostate CancerSIBRTNCT03664193
MRI-guided Stereotactic Body Radiotherapy (SBRT) With Simultaneous Integrated Boost for Prostate Cancer
A study testing SIBRT in people with Prostate Cancer, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
Radiation is delivered to the prostate and seminal vesicles in 5 treatment sessions (fractions). Doses ranging from 35-45 Gy in 5 fractions have demonstrated good outcomes with acceptable toxicity. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- SIBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2018to 28 Jan 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy-proven diagnosis of prostate adenocarcinoma
- NCCN defined low-, intermediate- and high-risk prostate cancer
- Age ≥ 18
- Patient must have prostate MRI with a PIRADS 3-5 lesion or PSMA positron emission tomography (PET) with an avid intraprostatic lesion
Who cannot join
- History of prior pelvic radiation (external beam or brachytherapy)
- Inability to undergo MRI
- Patients with metastatic disease (other than pelvic lymph nodes) are ineligible for this study
- American Urological Association (AUA) score >17 - AUA score >17
Trial locations and contacts
1 site in 1 country.
About this study
Radiation is delivered to the prostate and seminal vesicles in 5 treatment sessions (fractions). Doses ranging from 35-45 Gy in 5 fractions have demonstrated good outcomes with acceptable toxicity.
Read the detailed description
Prostate SBRT is a standard of care treatment for prostate cancer that has not spread to distant metastatic sites. Radiation is delivered to the prostate and seminal vesicles in 5 treatment sessions (fractions). Doses ranging from 35-45 Gy in 5 fractions have demonstrated good outcomes with acceptable toxicity. In this initial study, MRI guided treatment planning and delivery will be used to deliver 7 Gy to the entire prostate and seminal vesicles, with a selective boost of additional 0.5, 1.0, 1.5, or 2 Gy per fraction for a total dose of 37.5, 40, 42.5 or 45 Gy to biopsy-proven lesions, defined using MRI.
Hypothesis: MRI-guided treatment planning and delivery can selectively target high-risk prostate nodules and deliver a higher radiation dose, to achieve maximal local control without increasing treatment toxicity
- Conditions
- Prostate Cancer
- Being tested
- SIBRT
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIBRTRadiation
Patients will receive 35 Gy in 5 fractions. Also, patients will receive 0.5-2 Gy per fx for a total dose of 37.5, 40, 42.5, or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | Patients will receive 35 Gy in 5 fractions. Also, patients will receive 0.5-2 Gy per fx for a total dose of 37.5, 40, 42.5, or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy. Receives: Radiation: SIBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Delivering Stereotactic Body Radiotherapy(SBRT) With Simultaneous Integrated Boost(SIB).
Feasibility of delivering stereotactic body radiotherapy(SBRT) with simultaneous integrated boost(SIB). The investigators will track the number of treatment plans(number of participants) for each dose level (37.5, 40, 42.5, or 45 Gy) that can be delivered while meeting radiation planning objectives.
Measured: 2 months
Number of Participants Who Received Stereotactic Body Radiotherapy(SBRT) With Simultaneous Integrated Boost (SIB) Without Greater Than Grade 3 GU/GI Toxicities.
Measured: 1month
Secondary outcomes (2)
Expanded Prostate Cancer Index Composite (EPIC) Quality of Life Questionnaires Will be Assessed in Patients.
Health-related quality of life (HRQOL) measured using the Expanded Prostate Cancer Index Composite (EPIC) short-form questionnaire. The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Scores range from 0 to 100, lower scores indicate worse outcomes and higher EPIC scores represent better outcomes.
Measured: baseline, 3-6 months post treatment start
American Urological Association (AUA) Questionnaire Will be Assessed.
Health-related quality of life (HRQOL) measured using the AUA assessment will occur at baseline, and at first follow up. The American Urological Association (AUA) has developed the following questionnaire to help men determine how bothersome their urinary symptoms are and to check how effective their treatment is. 0-7 is mild, 8-19 is moderate and 20-35 is severe.
Measured: baseline, 3-6 months post treatment start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start24 Aug 2018
- Primary completion28 Jan 2020
- Study completion28 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Male patients with a histologically confirmed diagnosis of non-metastatic prostate adenocarcinoma, meeting the inclusion and exclusion criteria below, and electing to undergo definitive radiation treatment with SBRT, will be eligible for participation in this study. Patients will receive 35 Gy in five fractions, also, patients will receive a simultaneous integrated boost from 0.5-2 Gy per fx for a total dose of 37.5, 40, 42.5, or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy. Gastrointestinal/genitourinary toxicities will be assessed at every visit, including quality of life questionnaires and EPIC scores will be assessed at the one month follow up visits.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Josephine Kang, M.D., Principal investigator, Weill Cornell Medicine - New York Presbyterian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03664193
- Sponsor's protocol ID
- 1802019010
- Acronym
- SIBRT
- Status last verified
- Dec 2020
- First submitted
- 30 Aug 2018
- Last updated
- 5 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI-guided Stereotactic Body Radiotherapy (SBRT) With Simultaneous Integrated Boost for Prostate Cancer
- ClinicalTrials.gov ID
- NCT03664193
- Acronym / sponsor ID
- SIBRT / 1802019010
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 24 Aug 2018 (actual)
- Primary completion
- 28 Jan 2020 (actual)
- Study completion
- 28 Jan 2020 (actual)
- First posted
- 10 Sep 2018 (actual)
- Results
- Posted 5 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Radiation is delivered to the prostate and seminal vesicles in 5 treatment sessions (fractions). Doses ranging from 35-45 Gy in 5 fractions have demonstrated good outcomes with acceptable toxicity.
Detailed description
Prostate SBRT is a standard of care treatment for prostate cancer that has not spread to distant metastatic sites. Radiation is delivered to the prostate and seminal vesicles in 5 treatment sessions (fractions). Doses ranging from 35-45 Gy in 5 fractions have demonstrated good outcomes with acceptable toxicity. In this initial study, MRI guided treatment planning and delivery will be used to deliver 7 Gy to the entire prostate and seminal vesicles, with a selective boost of additional 0.5, 1.0, 1.5, or 2 Gy per fraction for a total dose of 37.5, 40, 42.5 or 45 Gy to biopsy-proven lesions, defined using MRI.
Hypothesis: MRI-guided treatment planning and delivery can selectively target high-risk prostate nodules and deliver a higher radiation dose, to achieve maximal local control without increasing treatment toxicity
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Male patients with a histologically confirmed diagnosis of non-metastatic prostate adenocarcinoma, meeting the inclusion and exclusion criteria below, and electing to undergo definitive radiation treatment with SBRT, will be eligible for participation in this study. Patients will receive 35 Gy in five fractions, also, patients will receive a simultaneous integrated boost from 0.5-2 Gy per fx for a total dose of 37.5, 40, 42.5, or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy. Gastrointestinal/genitourinary toxicities will be assessed at every visit, including quality of life questionnaires and EPIC scores will be assessed at the one month follow up visits.
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Radiation: SIBRTPatients will receive 35 Gy in 5 fractions. Also, patients will receive 0.5-2 Gy per fx for a total dose of 37.5, 40, 42.5, or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Biopsy-proven diagnosis of prostate adenocarcinoma
- NCCN defined low-, intermediate- and high-risk prostate cancer
- Age ≥ 18
- Patient must have prostate MRI with a PIRADS 3-5 lesion or PSMA positron emission tomography (PET) with an avid intraprostatic lesion
Key exclusion criteria (4 listed)
- History of prior pelvic radiation (external beam or brachytherapy)
- Inability to undergo MRI
- Patients with metastatic disease (other than pelvic lymph nodes) are ineligible for this study
- American Urological Association (AUA) score >17 - AUA score >17
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 |
|---|---|---|
| SIBRTPatients will receive 35 Gy in 5 fractions. Also, patients will receive 0.5-2 Gy per fx for a total dose of 37.5, 40, 42.5, or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy. | Radiation | Single Arm |
Primary outcome
Feasibility of Delivering Stereotactic Body Radiotherapy(SBRT) With Simultaneous Integrated Boost(SIB).
Time frame: 2 months
Feasibility of delivering stereotactic body radiotherapy(SBRT) with simultaneous integrated boost(SIB). The investigators will track the number of treatment plans(number of participants) for each dose level (37.5, 40, 42.5, or 45 Gy) that can be delivered while meeting radiation planning objectives.
Number of Participants Who Received Stereotactic Body Radiotherapy(SBRT) With Simultaneous Integrated Boost (SIB) Without Greater Than Grade 3 GU/GI Toxicities.
Time frame: 1month
2 secondary outcomes
Expanded Prostate Cancer Index Composite (EPIC) Quality of Life Questionnaires Will be Assessed in Patients.
Time frame: baseline, 3-6 months post treatment start
American Urological Association (AUA) Questionnaire Will be Assessed.
Time frame: baseline, 3-6 months post treatment start
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Josephine Kang, M.D. principal investigator
Weill Cornell Medicine - New York Presbyterian Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SIBRT in people with Prostate Cancer, run by Weill Medical College of Cornell University at 1 site in United States.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 5 Jan 2021. 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 United States. 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?
Yes. Results are posted in the registry (first posted 5 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Delivering Stereotactic Body Radiotherapy(SBRT) With Simultaneous Integrated Boost(SIB). (time frame: 2 months). The study lists 2 primary outcomes in all. 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 5 Jan 2021.