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

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ClinicalTrials.gov Identifier: NCT01953055
Recruitment Status : Active, not recruiting
First Posted : September 30, 2013
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
Andrew Loblaw, Sunnybrook Health Sciences Centre

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: Stereotactic ablative radiotherapy Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Stereotactic Ablative Radiotherapy Including Regional Lymph Node Irradiation for Patients With High Risk Prostate Cancer (SATURN)
Actual Study Start Date : November 2013
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Late GU and GI toxicities [ Time Frame: > 6 months post treatment ]
    Late GU and GI toxicities as assessed using RTOG grading schema

  2. Quality of Life (QoL) [ Time Frame: 5 years ]
    Quality of life using the Expanded Prostate Cancer Index Composite (EPIC) questionnaire

  3. Biochemical control [ Time Frame: 5 years ]
    Biochemical disease free survival

  4. Disease free survival [ Time Frame: 2 years ]
    Prostate biopsy 2 years post ADT cessation



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01953055


Locations
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Canada, Ontario
Odette Cancer Centre/Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5`
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
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Principal Investigator: Andrew Loblaw, MD Sunnybrook Health Sciences Centre/University of Toronto

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Responsible Party: Andrew Loblaw, Dr. Andrew Loblaw, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01953055     History of Changes
Other Study ID Numbers: ALOB-SATURN2013
First Posted: September 30, 2013    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: April 2017

Keywords provided by Andrew Loblaw, Sunnybrook Health Sciences Centre:
stereotactic ablative radiotherapy
androgen deprivation therapy

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases