Prostate CancerPhase 1/2SATURNNCT01953055
SABR Including Regional Lymph Node Irradiation for Patients With High Risk Prostate Cancer (SATURN)
A Phase 1/2 study testing Stereotactic ablative radiotherapy in people with Prostate Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
Current treatment options for high risk localized prostate cancer include radical prostatectomy +/- postoperative radiotherapy, radical radiotherapy with androgen deprivation therapy. Evidence has emerged that prostate cancer has a low α/β ratio in the range of 1-3 Gy. 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 radiotherapy
- 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
- Nov 2013to Sep 2023
- 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 of age
- histologically confirmed prostate adenocarcinoma (centrally reviewed)
- high risk prostate cancer, defined as at least one of clinical stage T3 or Gleason 8-10, or PSA > 20ng/mL
Who cannot join
- prior pelvic radiotherapy
- anticoagulation medication (if unsafe to discontinue for gold seed insertion)
- diagnosis of bleeding diathesis
- large prostate (>90cm3) on imaging at time of gold seed insertion
- no evidence of castrate resistance (defined as PSA < 3ng/mL while testosterone is < 0.7nmol/L
- definitive regional or distant metastatic disease on staging investigations
Trial locations and contacts
1 site in 1 country.
Canada1 site
Odette Cancer Centre/Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5'
About this study
Official title: Phase II Study of Stereotactic Ablative Radiotherapy Including Regional Lymph Node Irradiation for Patients With High Risk Prostate Cancer (SATURN)
Current treatment options for high risk localized prostate cancer include radical prostatectomy +/- postoperative radiotherapy, radical radiotherapy with androgen deprivation therapy. Evidence has emerged that prostate cancer has a low α/β ratio in the range of 1-3 Gy. Even with high risk tumors, prostate cancer is hypothesized to have a greater sensitivity to large fraction sizes and high dose per fraction radiotherapy theoretically allows for biological dose escalation with fewer visits and no additional toxicity. Therefore, we hope to determine the toxicity, quality of life, biochemical and pathological control of SBRT for high risk prostate cancer incorporating ENI.
- Conditions
- Prostate Cancer
- Being tested
- Stereotactic ablative radiotherapy
- Keywords
- stereotactic ablative radiotherapy, androgen deprivation therapy
- 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 radiotherapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic ablative radiotherapy | Experimental | 40 Gy in 5 fractions over 4 weeks to prostate; 25 Gy in 5 fractions over 4 weeks to pelvic lymph nodes given simulataneously. Receives: Radiation: Stereotactic ablative radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute GU and GI toxicities
Acute GU and GI toxicities as assessed using the Common Terminology for Adverse Events (CTCAE) v3.0
Measured: Baseline to 3 months post treatment
Secondary outcomes (4)
Late GU and GI toxicities
Late GU and GI toxicities as assessed using RTOG grading schema
Measured: > 6 months post treatment
Quality of Life (QoL)
Quality of life using the Expanded Prostate Cancer Index Composite (EPIC) questionnaire
Measured: 5 years
Biochemical control
Biochemical disease free survival
Measured: 5 years
Disease free survival
Prostate biopsy 2 years post ADT cessation
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2013 (estimated)
- Study startNov 2013
- Primary completionSep 2019
- Study completionSep 2023 (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 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 Loblaw, MD, Principal investigator, Sunnybrook Health Sciences Centre/University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01953055
- Sponsor's protocol ID
- ALOB-SATURN2013
- Acronym
- SATURN
- Status last verified
- Nov 2020
- First submitted
- 25 Sep 2013
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
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
- Phase II Study of Stereotactic Ablative Radiotherapy Including Regional Lymph Node Irradiation for Patients With High Risk Prostate Cancer (SATURN)
- ClinicalTrials.gov ID
- NCT01953055
- Acronym / sponsor ID
- SATURN / ALOB-SATURN2013
- Conditions
- Prostate Cancer
- Keywords
- stereotactic ablative radiotherapy, androgen deprivation therapy
- 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
- Nov 2013 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2023 (estimated)
- First posted
- 30 Sep 2013 (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.
Current treatment options for high risk localized prostate cancer include radical prostatectomy +/- postoperative radiotherapy, radical radiotherapy with androgen deprivation therapy. Evidence has emerged that prostate cancer has a low α/β ratio in the range of 1-3 Gy. Even with high risk tumors, prostate cancer is hypothesized to have a greater sensitivity to large fraction sizes and high dose per fraction radiotherapy theoretically allows for biological dose escalation with fewer visits and no additional toxicity. Therefore, we hope to determine the toxicity, quality of life, biochemical and pathological control of SBRT for high risk prostate cancer incorporating ENI.
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 radiotherapy | Experimental | Radiation: Stereotactic ablative radiotherapy40 Gy in 5 fractions over 4 weeks to prostate; 25 Gy in 5 fractions over 4 weeks to pelvic lymph nodes given simulataneously. |
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 of age
- histologically confirmed prostate adenocarcinoma (centrally reviewed)
- high risk prostate cancer, defined as at least one of clinical stage T3 or Gleason 8-10, or PSA > 20ng/mL
Key exclusion criteria (6 listed)
- prior pelvic radiotherapy
- anticoagulation medication (if unsafe to discontinue for gold seed insertion)
- diagnosis of bleeding diathesis
- large prostate (>90cm3) on imaging at time of gold seed insertion
- no evidence of castrate resistance (defined as PSA < 3ng/mL while testosterone is < 0.7nmol/L
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 radiotherapy | Radiation | Stereotactic ablative radiotherapy |
Primary outcome
Acute GU and GI toxicities
Time frame: Baseline to 3 months post treatment
Acute GU and GI toxicities as assessed using the Common Terminology for Adverse Events (CTCAE) v3.0
4 secondary outcomes
Late GU and GI toxicities
Time frame: > 6 months post treatment
Quality of Life (QoL)
Time frame: 5 years
Biochemical control
Time frame: 5 years
Disease free survival
Time frame: 2 years
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.
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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/University of Toronto
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 radiotherapy 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 4 inclusion and 6 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?
Acute GU and GI toxicities (time frame: Baseline to 3 months post treatment). 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 24 Nov 2020; AzTrials last refreshed its copy on 6 Nov 2026.