Clinical trial · Interventional
SPORT High-Risk Trial Evaluating SABR in Prostate Cancer
A Randomised Feasibility Study Evaluating Stereotactic Prostate Radiotherapy In High-Risk Localised Prostate Cancer With or Without Elective Nodal Irradiation
- 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)
The study will examine stereotactic ablative body radiotherapy (SABR), a new technique to deliver radiotherapy to men with prostate cancer. In addition to this, it will look at the effect of SABR on levels of markers of radiation exposure and bowel damage, along with other potential markers of outcome and side effects. Quality of life and any side effects that develop during and after treatment will also be assessed.
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 |
|---|---|---|---|
| Stereotatic Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SABR to prostate / seminal vesicles with pelvic ENI
- description
- 36.25Gy / 5 fractions to prostate and seminal vesicles with additional SABR (25Gy /5 fractions) delivered to the pelvic nodes.
- interventionNames
- Radiation: Stereotatic Radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- SABR to prostate and seminal vesicles only
- description
- 36.25Gy / 5 fractions to prostate and seminal vesicles.
- interventionNames
- Radiation: Stereotatic Radiotherapy
Primary outcomes (5)
- measure
- Adequate recruitment rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Patients with histologically confirmed prostate adenocarcinoma who elect for radical radiotherapy, with at least one of the following features: * clinical stage T3a N0 M0 * Gleason score 7 (4+3) or above * PSA \> 20 No evidence of nodal or distant metastatic disease WHO performance status 0-2 Life expectancy of at least 5 years Men greater than or equal to 18 years Ability to understand and willingness to sign a written informed consent document (completed prior to registration and subsequent randomization), along with willingness to co-operate with follow-up Planned to receive 12-36 months of ADT as part of standard treatment Exclusion Criteria: T stage greater than or equal to T3b / T4 Prostate volume \> 90cc Current evidence of: * inflammatory bowel disease or other chronic bowel disorder * Autoimmune disease * Active uncontrolled bacterial, viral or fungal infection * Serious uncontrolled concomitant disease * Known coagulopathy or bleeding diasthesis * Anticoagulation medication (if unsafe to insert for seed insertion) * Bilateral hip prosthesis or fixation which would interfere with standard radiation beam configuration * Concurrent experimental or cytotoxic drugs * Allergy to gold * Severe lower urinary tract symptoms - International Prostate Symptom Score (IPSS) \> 19 * Any other contra-indication to hormonal therapy or radical radiotherapy. History of: * Previous major abdominal surgery or history of bowel adhesions * Prior pelvic radiotherapy * Active malignancy within the preceding five years (other than basal cell carcinoma) Evidence of: \- Castrate-resistance (rising PSA with castrate levels of testosterone on LHRHa and anti-androgen)
References
Publications (0)
Data not yet available