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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
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring stereotactic ablative radiotherapy, androgen deprivation therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

First Posted
September 25, 2013
Last Updated
November 23, 2020
Sponsor
Sunnybrook Health Sciences Centre
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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

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SABR Including Regional Lymph Node Irradiation for Patients With High Risk Prostate Cancer (SATURN)

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