Prostate Cancer5STAR-PCNCT04245670
5 Fractions of Pelvic SABR With Intra Prostatic SABR Boost:
A study testing Stereotactic Ablative Body Radiotherapy (SABR) 35-50 Gy/5 in people with Prostate Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
Stereotactic Ablative Body Radiotherapy (SABR) given in 5 weekly fractions. Simultaneously treating the pelvic lymph nodes, prostate and MRI-nodule to a total dose of 25 Gy, 35 Gy and up to 50 Gy, respectively. The radiation will be given with 6-18 months of ADT. 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?
- Stereotactic Ablative Body Radiotherapy (SABR) 35-50 Gy/5
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteCanada
- Study dates
- 31 May 2018to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Histologically confirmed prostate adenocarcinoma (centrally reviewed)
- High-intermediate risk defined as two or more of: T2c, Gleason 7 OR PSA 10-20ng/ml,
- High-risk prostate cancer, defined as at least one of: T3, Gleason 8-10, OR PSA > 20 ng/mL
- Willing to give informed consent to participate in this clinical trial
- Able and willing to complete EPIC, PORPUS and EQ-5D questionnaires
Who cannot join
- Prior pelvic radiotherapy
- Contraindication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease
- Anticoagulation medication (if unsafe to discontinue for fiducial insertion)
- Diagnosis of bleeding diathesis
- Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) >20
- Evidence of castrate resistance (defined as PSA < 3 ng/ml while testosterone is < 0.7nmol/l. Patients could have been on combined androgen blockade but are excluded if this was started due to PSA progression.
- Definitive extrapelvic nodal or distant metastatic disease on staging investigations.
- Hip prosthesis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 5 Fractions of Pelvic SABR With Intra Prostatic SABR Boost:A Phase II Study (5STAR-PC)
Stereotactic Ablative Body Radiotherapy (SABR) given in 5 weekly fractions. Simultaneously treating the pelvic lymph nodes, prostate and MRI-nodule to a total dose of 25 Gy, 35 Gy and up to 50 Gy, respectively. The radiation will be given with 6-18 months of ADT.
5-fraction SABR is a feasible, well-tolerated, effective and cost effective treatment for high-intermediate and high risk prostate cancer with/without an image-guided intraprostatic boost.
- Conditions
- Prostate Cancer
- Being tested
- Stereotactic Ablative Body Radiotherapy (SABR) 35-50 Gy/5
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Ablative Body Radiotherapy (SABR) 35-50 Gy/5Radiation
Stereotactic Ablative Body Radiotherapy (SABR) given in 5 weekly fractions. Simultaneously treating the pelvic lymph nodes, prostate and MRI-nodule to a total dose of 25 Gy, 35 Gy and up to 50 Gy, respectively. The radiation will be given with 6-18 months of ADT.
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Ablative Body Radiotherapy (SABR) 35-50 Gy/5 | Experimental | Stereotactic Ablative Body Radiotherapy (SABR) given in 5 weekly fractions. Simultaneously treating the pelvic lymph nodes, prostate and MRI-nodule to a total dose of 25 Gy, 35 Gy and up to 50 Gy, respectively. The radiation will be given with 6-18 months of ADT. Receives: Radiation: Stereotactic Ablative Body Radiotherapy (SABR) 35-50 Gy/5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Toxicity
To document the acute urinary toxicity using the Common Terminology Criteria for Adverse Events (CTCAE v4.0) criteria
Measured: Baseline to 3 months post completion of treatment
Acute Toxicity
To document the acute bowel toxicity using the Common Terminology Criteria for Adverse Events (CTCAE v4.0) criteria
Measured: Baseline to 3 months post completion of treatment
Secondary outcomes (5)
Quality of Life outcome
Measuring quality of life using Expanded Prostate Index Composite (EPIC)
Measured: Baseline to end of 5 year follow up
Biochemical disease-free survival
Biochemical disease-free survival
Measured: Baseline to end of 5 year follow up
Quality of life outcome
Health utilities using the EQ-5D Quality of Life Questionnaire tool
Measured: Baseline to end of 5 year follow up
Quality of life outcome
Health utilities using PORPUS-U Quality of Life Questionnaire tool
Measured: Baseline to end of 5 year follow up
Economic analysis
Cost effectiveness of treatment.Quality of life and cost estimates will be captured for each patient from time of the initiation of treatment until death. The effectiveness endpoints will be biochemical disease free survival and quality-adjusted life years (QALYs). QALY will be calculated by survival (in years) multiplied by a utility weight associated with a certain condition.
Measured: Baseline to end of 5 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start31 May 2018
- Primary completion30 Aug 2021
- Study completion31 Jan 2025 (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.
- More trials run by Sunnybrook Health Sciences CentreThe 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
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Prostate Cure Foundation
- Responsible party
- Sponsor
- Investigators
- Andrew Loblaw, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04245670
- Sponsor's protocol ID
- 5STAR-PC
- Acronym
- 5STAR-PC
- Status last verified
- Sep 2022
- First submitted
- 27 Jan 2020
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 5 Fractions of Pelvic SABR With Intra Prostatic SABR Boost:A Phase II Study (5STAR-PC)
- ClinicalTrials.gov ID
- NCT04245670
- Acronym / sponsor ID
- 5STAR-PC / 5STAR-PC
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Prostate Cure Foundation
- Study start
- 31 May 2018 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 29 Jan 2020 (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.
Stereotactic Ablative Body Radiotherapy (SABR) given in 5 weekly fractions. Simultaneously treating the pelvic lymph nodes, prostate and MRI-nodule to a total dose of 25 Gy, 35 Gy and up to 50 Gy, respectively. The radiation will be given with 6-18 months of ADT.
5-fraction SABR is a feasible, well-tolerated, effective and cost effective treatment for high-intermediate and high risk prostate cancer with/without an image-guided intraprostatic boost.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Ablative Body Radiotherapy (SABR) 35-50 Gy/5 | Experimental | Radiation: Stereotactic Ablative Body Radiotherapy (SABR) 35-50 Gy/5Stereotactic Ablative Body Radiotherapy (SABR) given in 5 weekly fractions. Simultaneously treating the pelvic lymph nodes, prostate and MRI-nodule to a total dose of 25 Gy, 35 Gy and up to 50 Gy, respectively. The radiation will be given with 6-18 months of ADT. |
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)
- Histologically confirmed prostate adenocarcinoma (centrally reviewed)
- High-intermediate risk defined as two or more of: T2c, Gleason 7 OR PSA 10-20ng/ml,
- High-risk prostate cancer, defined as at least one of: T3, Gleason 8-10, OR PSA > 20 ng/mL
- Willing to give informed consent to participate in this clinical trial
- Able and willing to complete EPIC, PORPUS and EQ-5D questionnaires
Key exclusion criteria (8 listed)
- Prior pelvic radiotherapy
- Contraindication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease
- Anticoagulation medication (if unsafe to discontinue for fiducial insertion)
- Diagnosis of bleeding diathesis
- Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) >20
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 |
|---|---|---|
| Stereotactic Ablative Body Radiotherapy (SABR) 35-50 Gy/5Stereotactic Ablative Body Radiotherapy (SABR) given in 5 weekly fractions. Simultaneously treating the pelvic lymph nodes, prostate and MRI-nodule to a total dose of 25 Gy, 35 Gy and up to 50 Gy, respectively. The radiation will be given with 6-18 months of ADT. | Radiation | Stereotactic Ablative Body Radiotherapy (SABR) 35-50 Gy/5 |
Primary outcome
Acute Toxicity
Time frame: Baseline to 3 months post completion of treatment
To document the acute urinary toxicity using the Common Terminology Criteria for Adverse Events (CTCAE v4.0) criteria
Acute Toxicity
Time frame: Baseline to 3 months post completion of treatment
To document the acute bowel toxicity using the Common Terminology Criteria for Adverse Events (CTCAE v4.0) criteria
5 secondary outcomes
Quality of Life outcome
Time frame: Baseline to end of 5 year follow up
Biochemical disease-free survival
Time frame: Baseline to end of 5 year follow up
Quality of life outcome
Time frame: Baseline to end of 5 year follow up
Quality of life outcome
Time frame: Baseline to end of 5 year follow up
Economic analysis
Time frame: Baseline to end of 5 year follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Individual participant dataSharing planned: Yes
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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.
Andrew Loblaw, MD 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 Stereotactic Ablative Body Radiotherapy (SABR) 35-50 Gy/5 in people with Prostate Cancer, run by Sunnybrook Health Sciences Centre 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 8 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: status not confirmed, as of the sponsor's last update on 28 Sep 2022. 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?
Results are not available in the source record.
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?
Acute Toxicity (time frame: Baseline to 3 months post completion of treatment). 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 28 Sep 2022.