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

Phase 1

• Conditions: Prostate Cancer
• Interventions: Radiation: Stereotactic ablative radiotherapy

• Registration Number: NCT01953055
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-25
• Study First Submitted QC: 2013-09-25
• Study First Posted: 2013-09-30
• Study Start: 2013-11
• Primary Completion: 2019-09
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-23
• Last Update Posted: 2020-11-24
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stereotactic ablative radiotherapy	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.

Primary Outcome Measures

Name	Time	Method
Acute GU and GI toxicities	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

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

Trial Locations

Locations (1)

Odette Cancer Centre/Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada