Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatment stereotactic ablative radiotherapy
Phase phase 1/phase 2
Sponsor Sunnybrook Health Sciences Centre
Start date November 2013
End date September 2019
Trial size 30 participants
Trial identifier NCT01953055, ALOB-SATURN2013

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(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.
stereotactic ablative radiotherapy

Primary Outcomes

Measure
Acute GU and GI toxicities
time frame: Baseline to 3 months post treatment

Secondary Outcomes

Measure
Late GU and GI toxicities
time frame: > 6 months post treatment
Quality of Life (QoL)
time frame: 5 years
Biochemical control
time frame: 5 years
Disease free survival
time frame: 2 years

Eligibility Criteria

Male participants at least 18 years old.

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

Additional Information

Official title Phase II Study of Stereotactic Ablative Radiotherapy Including Regional Lymph Node Irradiation for Patients With High Risk Prostate Cancer (SATURN)
Principal investigator Andrew Loblaw, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre.