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

Prostate Cancer Clinical Trial

— SATURN  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01953055
• Other study ID #: ALOB-SATURN2013
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: November 2013
• Est. completion date: September 2023

Study information

• Verified date: November 2020
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: September 2023
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Stereotactic ablative radiotherapy

Locations

Country	Name	City	State
Canada	Odette Cancer Centre/Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute GU and GI toxicities	Acute GU and GI toxicities as assessed using the Common Terminology for Adverse Events (CTCAE) v3.0	Baseline to 3 months post treatment
Secondary	Late GU and GI toxicities	Late GU and GI toxicities as assessed using RTOG grading schema	> 6 months post treatment
Secondary	Quality of Life (QoL)	Quality of life using the Expanded Prostate Cancer Index Composite (EPIC) questionnaire	5 years
Secondary	Biochemical control	Biochemical disease free survival	5 years
Secondary	Disease free survival	Prostate biopsy 2 years post ADT cessation	2 years