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

NCT01953055 | Unknown Phase 1 DMC

• 1 other identifier: ALOB-SATURN2013
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

stereotactic ablative radiotherapy; androgen deprivation therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Late GU and GI toxicities

  > 6 months post treatment

• Quality of Life (QoL)

  5 years

• Biochemical control

  5 years

• Disease free survival

  2 years

Study Arms (1)

Stereotactic ablative radiotherapy

EXPERIMENTAL

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

Interventions

Stereotactic ablative radiotherapy RADIATION

Stereotactic ablative radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Odette Cancer Centre/Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5', Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Andrew Loblaw, MD

  Sunnybrook Health Sciences Centre/University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Andrew Loblaw

Study Record Dates

• First Submitted: September 25, 2013
• First Posted: September 30, 2013
• Study Start: November 1, 2013
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2023
• Last Updated: November 24, 2020

Record last verified: 2020-11

Locations

CA (1)