SABR Including Regional Lymph Node Irradiation for Patients With High Risk Prostate Cancer (SATURN) (SATURN)
Primary Purpose
Prostate Cancer
Status
Unknown status
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Stereotactic ablative radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring stereotactic ablative radiotherapy, androgen deprivation therapy
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Odette Cancer Centre/Sunnybrook Health Sciences Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Stereotactic ablative radiotherapy
Arm Description
40 Gy in 5 fractions over 4 weeks to prostate; 25 Gy in 5 fractions over 4 weeks to pelvic lymph nodes given simulataneously.
Outcomes
Primary Outcome Measures
Acute GU and GI toxicities
Acute GU and GI toxicities as assessed using the Common Terminology for Adverse Events (CTCAE) v3.0
Secondary Outcome Measures
Late GU and GI toxicities
Late GU and GI toxicities as assessed using RTOG grading schema
Quality of Life (QoL)
Quality of life using the Expanded Prostate Cancer Index Composite (EPIC) questionnaire
Biochemical control
Biochemical disease free survival
Disease free survival
Prostate biopsy 2 years post ADT cessation
Full Information
NCT ID
NCT01953055
First Posted
September 25, 2013
Last Updated
November 23, 2020
Sponsor
Sunnybrook Health Sciences Centre
1. Study Identification
Unique Protocol Identification Number
NCT01953055
Brief Title
SABR Including Regional Lymph Node Irradiation for Patients With High Risk Prostate Cancer (SATURN)
Acronym
SATURN
Official Title
Phase II Study of Stereotactic Ablative Radiotherapy Including Regional Lymph Node Irradiation for Patients With High Risk Prostate Cancer (SATURN)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (Actual)
Primary Completion Date
September 2019 (Actual)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
stereotactic ablative radiotherapy, androgen deprivation therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Stereotactic ablative radiotherapy
Arm Type
Experimental
Arm Description
40 Gy in 5 fractions over 4 weeks to prostate; 25 Gy in 5 fractions over 4 weeks to pelvic lymph nodes given simulataneously.
Intervention Type
Radiation
Intervention Name(s)
Stereotactic ablative radiotherapy
Primary Outcome Measure Information:
Title
Acute GU and GI toxicities
Description
Acute GU and GI toxicities as assessed using the Common Terminology for Adverse Events (CTCAE) v3.0
Time Frame
Baseline to 3 months post treatment
Secondary Outcome Measure Information:
Title
Late GU and GI toxicities
Description
Late GU and GI toxicities as assessed using RTOG grading schema
Time Frame
> 6 months post treatment
Title
Quality of Life (QoL)
Description
Quality of life using the Expanded Prostate Cancer Index Composite (EPIC) questionnaire
Time Frame
5 years
Title
Biochemical control
Description
Biochemical disease free survival
Time Frame
5 years
Title
Disease free survival
Description
Prostate biopsy 2 years post ADT cessation
Time Frame
2 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Loblaw, MD
Organizational Affiliation
Sunnybrook Health Sciences Centre/University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Odette Cancer Centre/Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5'
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
SABR Including Regional Lymph Node Irradiation for Patients With High Risk Prostate Cancer (SATURN)
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