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

NCT ID: NCT01953055

Last Updated: 2020-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2023-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Keywords

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stereotactic ablative radiotherapy androgen deprivation therapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Stereotactic ablative radiotherapy

Intervention Type RADIATION

Interventions

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Stereotactic ablative radiotherapy

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Sunnybrook Health Sciences Centre

OTHER

Sponsor Role lead

Responsible Party

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Andrew Loblaw

Dr. Andrew Loblaw

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrew Loblaw, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre/University of Toronto

Locations

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Odette Cancer Centre/Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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ALOB-SATURN2013

Identifier Type: -

Identifier Source: org_study_id