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

Phase II Study of Stereotactic Ablative Radiotherapy Including Regional Lymph Node Irradiation for Patients With High Risk Prostate Cancer (SATURN)

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01953055

Acronym

SATURN

Enrollment

Registered

2013-09-30

Start date

2013-11-30

Completion date

2023-09-30

Last updated

2020-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

stereotactic ablative radiotherapy, androgen deprivation therapy

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.

Interventions

RADIATIONStereotactic ablative radiotherapy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026