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

November 23, 2020 updated by: Andrew Loblaw, Sunnybrook Health Sciences Centre

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5'
        • Odette Cancer Centre/Sunnybrook Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stereotactic ablative radiotherapy
40 Gy in 5 fractions over 4 weeks to prostate; 25 Gy in 5 fractions over 4 weeks to pelvic lymph nodes given simulataneously.
Radiation: Stereotactic ablative radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline to 3 months post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Late GU and GI toxicities
Time Frame: > 6 months post treatment
Late GU and GI toxicities as assessed using RTOG grading schema
> 6 months post treatment
Quality of Life (QoL)
Time Frame: 5 years
Quality of life using the Expanded Prostate Cancer Index Composite (EPIC) questionnaire
5 years
Biochemical control
Time Frame: 5 years
Biochemical disease free survival
5 years
Disease free survival
Time Frame: 2 years
Prostate biopsy 2 years post ADT cessation
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Investigators

  • Principal Investigator: Andrew Loblaw, MD, Sunnybrook Health Sciences Centre/University of Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2013

Primary Completion (Actual)

September 1, 2019

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

September 25, 2013

First Submitted That Met QC Criteria

September 25, 2013

First Posted (Estimate)

September 30, 2013

Study Record Updates

Last Update Posted (Actual)

November 24, 2020

Last Update Submitted That Met QC Criteria

November 23, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALOB-SATURN2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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