Clinical trial · Interventional
5 Fractions of Pelvic SABR With Intra Prostatic SABR Boost:
5 Fractions of Pelvic SABR With Intra Prostatic SABR Boost:A Phase II Study (5STAR-PC)
- 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)
Stereotactic Ablative Body Radiotherapy (SABR) given in 5 weekly fractions. Simultaneously treating the pelvic lymph nodes, prostate and MRI-nodule to a total dose of 25 Gy, 35 Gy and up to 50 Gy, respectively. The radiation will be given with 6-18 months of ADT. 5-fraction SABR is a feasible, well-tolerated, effective and cost effective treatment for high-intermediate and high risk prostate cancer with/without an image-guided intraprostatic boost.
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 Body Radiotherapy (SABR) 35-50 Gy/5 | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Stereotactic Ablative Body Radiotherapy (SABR) 35-50 Gy/5
- description
- Stereotactic Ablative Body Radiotherapy (SABR) given in 5 weekly fractions. Simultaneously treating the pelvic lymph nodes, prostate and MRI-nodule to a total dose of 25 Gy, 35 Gy and up to 50 Gy, respectively. The radiation will be given with 6-18 months of ADT.
- interventionNames
- Radiation: Stereotactic Ablative Body Radiotherapy (SABR) 35-50 Gy/5
Primary outcomes (2)
- measure
- Acute Toxicity
- timeFrame
- Baseline to 3 months post completion of treatment
- description
- To document the acute urinary toxicity using the Common Terminology Criteria for Adverse Events (CTCAE v4.0) criteria
- measure
- Acute Toxicity
- timeFrame
- Baseline to 3 months post completion of treatment
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Histologically confirmed prostate adenocarcinoma (centrally reviewed) * High-intermediate risk defined as two or more of: T2c, Gleason 7 OR PSA 10-20ng/ml, * High-risk prostate cancer, defined as at least one of: T3, Gleason 8-10, OR PSA \> 20 ng/mL * Willing to give informed consent to participate in this clinical trial * Able and willing to complete EPIC, PORPUS and EQ-5D questionnaires Exclusion Criteria * Prior pelvic radiotherapy * Contraindication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease * Anticoagulation medication (if unsafe to discontinue for fiducial insertion) * Diagnosis of bleeding diathesis * Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) \>20 * Evidence of castrate resistance (defined as PSA \< 3 ng/ml while testosterone is \< 0.7nmol/l. Patients could have been on combined androgen blockade but are excluded if this was started due to PSA progression. * Definitive extrapelvic nodal or distant metastatic disease on staging investigations. * Hip prosthesis
References
Publications (0)
Data not yet available