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

Sunnybrook Health Sciences Centre

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Prostate Cancer

Treatments

Radiation: Stereotactic ablative radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01953055

ALOB-SATURN2013

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No 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