Prostate AdenocarcinomaPhase 1/22STARNCT02031328
Two StereoTactic Ablative Adaptive Radiotherapy Treatments for Localized Prostate Cancer
A Phase 1/2 study testing Stereotactic Ablative Radiation in people with Prostate Adenocarcinoma, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
You have been asked to consider participating in the study because you have a cancer of the prostate, which is to be treated with external beam radiation. You have chosen or felt not to be a good candidate for just watching your cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Adenocarcinoma
- What is being tested?
- Stereotactic Ablative Radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2014to 12 Sep 2024
- Phase
- Phase 1/2
- 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
- Informed consent obtained
- Men >18 years
- Histologically confirmed prostate adenocarcinoma (centrally reviewed)
- Low and intermediate risk prostate cancer, defined as clinical stage T1-2b, Gleason Score less than/equal to 7, and PSA less than 20 ng/mL (low risk patients will have refused or felt to be inappropriate for active surveillance)
Who cannot join
- Androgen deprivation therapy (LHRH-agonists or antiandrogens)>6 mo
- Prior pelvic radiotherapy
- Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
- Diagnosis of bleeding diathesis
- Large prostate (>90cm3) on imaging
- Immunosuppressive medications
- Inflammatory bowel disease
- Presence of a hip prosthesis
Trial locations and contacts
1 site in 1 country.
Canada1 site
Sunnybrook Health Science Centre Odette Cancer Centre
Toronto, Ontario, M4N 3M5
About this study
You have been asked to consider participating in the study because you have a cancer of the prostate, which is to be treated with external beam radiation. You have chosen or felt not to be a good candidate for just watching your cancer. As your doctor has informed you, this involves delivering small amounts of radiation daily over several weeks. Normally, a small field directed to the prostate gland is given for 7.5 - 8 weeks. In total, 39 days of radiation are delivered. There is now growing evidence that prostate cancer cells may be killed more effectively if higher doses of radiation are delivered everyday (known as hypofractionation). However, the downside to such a strategy is the potential to cause more side effects because normal organs (such as the rectum and bladder) are also exposed to the higher doses. Stereotactic ablative radiotherapy (SABR) is a high-precision technique which has the ability to deliver radiation in a more focused manor, meaning that the radiation dose can be "sculpted" to the prostate gland, while minimizing the amount of radiation to the bladder and rectum.
A certain amount of movement of the prostate normally occurs within the body. To make sure that the prostate will not be missed, a margin of tissue around the prostate also needs to be treated. Although a wide margin will ensure that the prostate is included, it will also cause more normal tissue to receive high doses of radiation. This, in turn, would result in more side effects. To reduce the margin needed around the prostate, and side effects, tiny gold seeds measuring 3.0 x 1.2mm will be inserted into the prostate which can be seen using a special type of X-Ray camera called a portal imager during treatment. This will allow for targeting of the prostate gland more precisely so that a significantly smaller margin of normal tissue will need to be treated. By using gold seeds in conjunction with SABR, there is the potential to safely deliver a more intensive dose of radiation to the prostate gland without increasing the amount of side effects.
Read more
In other studies where shorter and more intense courses of radiation have been given using similar high-precision techniques, the side effects of treatment have indeed been no worse than the usual techniques. Over the last 7 years, Sunnybrook researchers have treated over three hundred prostate cancer patients on various research protocols with SABR. In those protocols, patients received 5 SBRT treatments over 29 days and this is currently being compared to 5 SBRT treatments over 11 days in an ongoing randomized study. In the United States, several groups have investigated the 5 SBRT approach in 11 days or less and early findings suggest a good tolerance.
The study is being done to determine the side effects, quality of life and efficacy of 2-fraction adaptive SBRT technique (2STAR) in the treatment of low and intermediate risk prostate cancer. All participants will receive the same dose and fractionation scheme.
- Conditions
- Prostate Adenocarcinoma
- Being tested
- Stereotactic Ablative Radiation
- Keywords
- prostate, radiation, stereotactic body radiation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Ablative RadiationRadiation
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Ablative Radiation | Experimental | Stereotactic Ablative Radiation 26 Gy in 2 fractions, once weekly to prostate Receives: Radiation: Stereotactic Ablative Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
To determine the prostate-specific quality of life (QOL) using the Expanded Prostate Cancer Index Composite (EPIC) 37 questionnaire for patients undergoing a 2 fraction SBRT protocol. QOL using the Expanded Prostate Cancer Index Composite (EPIC) will be obtained at baseline, weeks 1, 4, 12, month 6 and every 6 months until year 5.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startJan 2014
- Primary completion12 Sep 2014
- Study completion12 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate AdenocarcinomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Loblaw, Sunnybrook Health Sciences Centre
- Investigators
- Andrew A Loblaw, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02031328
- Sponsor's protocol ID
- 312-2013
- Acronym
- 2STAR
- Status last verified
- Nov 2020
- First submitted
- 7 Jan 2014
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ong WL, Davidson M, Cheung P, Chung H, Chu W, Detsky J, Liu S, Morton G, Szumacher E, Tseng CL, Vesprini D, Ravi A, McGuffin M, Zhang L, Mamedov A, Deabreu A, Kulasingham-Poon M, Loblaw A. Dosimetric correlates of toxicities and quality of life following two-fraction stereotactic ablative radiotherapy (SABR) for prostate cancer. Radiother Oncol. 2023 Nov;188:109864. doi: 10.1016/j.radonc.2023.109864. Epub 2023 Aug 22.
PubMed 37619656Ong WL, Cheung P, Chung H, Chu W, Detsky J, Liu S, Morton G, Szumacher E, Tseng CL, Vesprini D, Davidson M, Ravi A, McGuffin M, Zhang L, Mamedov A, Deabreu A, Kulasingham-Poon M, Loblaw A. To Boost or Not to Boost: Pooled Analyses From 2-Fraction SABR Trials for Localized Prostate Cancer. Int J Radiat Oncol Biol Phys. 2023 Dec 1;117(5):1153-1162. doi: 10.1016/j.ijrobp.2023.06.250. Epub 2023 Jul 5.
PubMed 37419394
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two StereoTactic Ablative Adaptive Radiotherapy Treatments for Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT02031328
- Acronym / sponsor ID
- 2STAR / 312-2013
- Conditions
- Prostate Adenocarcinoma
- Keywords
- prostate, radiation, stereotactic body radiation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- 12 Sep 2014 (actual)
- Study completion
- 12 Sep 2024 (estimated)
- First posted
- 9 Jan 2014 (estimated)
- 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.
You have been asked to consider participating in the study because you have a cancer of the prostate, which is to be treated with external beam radiation. You have chosen or felt not to be a good candidate for just watching your cancer. As your doctor has informed you, this involves delivering small amounts of radiation daily over several weeks. Normally, a small field directed to the prostate gland is given for 7.5 - 8 weeks. In total, 39 days of radiation are delivered. There is now growing evidence that prostate cancer cells may be killed more effectively if higher doses of radiation are delivered everyday (known as hypofractionation). However, the downside to such a strategy is the potential to cause more side effects because normal organs (such as the rectum and bladder) are also exposed to the higher doses. Stereotactic ablative radiotherapy (SABR) is a high-precision technique which has the ability to deliver radiation in a more focused manor, meaning that the radiation dose can be "sculpted" to the prostate gland, while minimizing the amount of radiation to the bladder and rectum.
A certain amount of movement of the prostate normally occurs within the body. To make sure that the prostate will not be missed, a margin of tissue around the prostate also needs to be treated. Although a wide margin will ensure that the prostate is included, it will also cause more normal tissue to receive high doses of radiation. This, in turn, would result in more side effects. To reduce the margin needed around the prostate, and side effects, tiny gold seeds measuring 3.0 x 1.2mm will be inserted into the prostate which can be seen using a special type of X-Ray camera called a portal imager during treatment. This will allow for targeting of the prostate gland more precisely so that a significantly smaller margin of normal tissue will need to be treated. By using gold seeds in conjunction with SABR, there is the potential to safely deliver a more intensive dose of radiation to the prostate gland without increasing the amount of side effects.
In other studies where shorter and more intense courses of radiation have been given using similar high-precision techniques, the side effects of treatment have indeed been no worse than the usual techniques. Over the last 7 years, Sunnybrook researchers have treated over three hundred prostate cancer patients on various research protocols with SABR. In those protocols, patients received 5 SBRT treatments over 29 days and this is currently being compared to 5 SBRT treatments over 11 days in an ongoing randomized study. In the United States, several groups have investigated the 5 SBRT approach in 11 days or less and early findings suggest a good tolerance.
The study is being done to determine the side effects, quality of life and efficacy of 2-fraction adaptive SBRT technique (2STAR) in the treatment of low and intermediate risk prostate cancer. All participants will receive the same dose and fractionation scheme.
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 Radiation | Experimental | Radiation: Stereotactic Ablative RadiationStereotactic Ablative Radiation 26 Gy in 2 fractions, once weekly to prostate |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Informed consent obtained
- Men >18 years
- Histologically confirmed prostate adenocarcinoma (centrally reviewed)
- Low and intermediate risk prostate cancer, defined as clinical stage T1-2b, Gleason Score less than/equal to 7, and PSA less than 20 ng/mL (low risk patients will have refused or felt to be inappropriate for active surveillance)
Key exclusion criteria (8 listed)
- Androgen deprivation therapy (LHRH-agonists or antiandrogens)>6 mo
- Prior pelvic radiotherapy
- Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
- Diagnosis of bleeding diathesis
- Large prostate (>90cm3) on imaging
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 Radiation | Radiation | Stereotactic Ablative Radiation |
Primary outcome
Quality of Life
Time frame: 5 years
To determine the prostate-specific quality of life (QOL) using the Expanded Prostate Cancer Index Composite (EPIC) 37 questionnaire for patients undergoing a 2 fraction SBRT protocol. QOL using the Expanded Prostate Cancer Index Composite (EPIC) will be obtained at baseline, weeks 1, 4, 12, month 6 and every 6 months until year 5.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Derived from this study: PubMed 37619656Ong WL, Davidson M, Cheung P, Chung H, Chu W, Detsky J, Liu S, Morton G, Szumacher E, Tseng CL, Vesprini D, Ravi A, McGuffin M, Zhang L, Mamedov A, Deabreu A, Kulasingham-Poon M, Loblaw A. Dosimetric correlates of toxicities and quality of life following two-fraction stereotactic ablative radiotherapy (SABR) for prostate cancer. Radiother Oncol. 2023 Nov;188:109864. doi: 10.1016/j.radonc.2023.109864. Epub 2023 Aug 22.
- Derived from this study: PubMed 37419394Ong WL, Cheung P, Chung H, Chu W, Detsky J, Liu S, Morton G, Szumacher E, Tseng CL, Vesprini D, Davidson M, Ravi A, McGuffin M, Zhang L, Mamedov A, Deabreu A, Kulasingham-Poon M, Loblaw A. To Boost or Not to Boost: Pooled Analyses From 2-Fraction SABR Trials for Localized Prostate Cancer. Int J Radiat Oncol Biol Phys. 2023 Dec 1;117(5):1153-1162. doi: 10.1016/j.ijrobp.2023.06.250. Epub 2023 Jul 5.
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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 A Loblaw 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 Phase 1/2 study testing Stereotactic Ablative Radiation in people with Prostate Adenocarcinoma, 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 4 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 24 Nov 2020. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Quality of Life (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02031328, which also lists 2 linked publications.
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 24 Nov 2020.