Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic ablative radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Stereotactic ablative radiotherapy
- description
- 40 Gy in 5 fractions over 4 weeks to prostate; 25 Gy in 5 fractions over 4 weeks to pelvic lymph nodes given simulataneously.
- interventionNames
- Radiation: Stereotactic ablative radiotherapy
Primary outcomes (1)
- measure
- Acute GU and GI toxicities
- timeFrame
- Baseline to 3 months post treatment
- description
- Acute GU and GI toxicities as assessed using the Common Terminology for Adverse Events (CTCAE) v3.0
Secondary outcomes (4)
- measure
- Late GU and GI toxicities
- timeFrame
- > 6 months post treatment
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available