Clinical trial · Interventional
Prostate SABR With Intra-Prostatic SABR Boost
Prostate SABR With Intra-Prostatic SABR Boost: A Phase II Study
NCT04212715CI-TRIAL-00042534recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 Radiation (SABR/SBRT) will be prescribed to a dose of 35 Gy in 5 fractions, once weekly to prostate with a simultaneous intra-prostatic boost to the MR detected nodule up to 50Gy. The pelvic lymph nodes and seminal vesicles will also receive 25 Gy in 5 weekly fractions.
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 |
|---|---|---|---|
| Pelvic SABR with intra-prostatic SABR | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental arm
- description
- SABR 35Gy/5 to prostate, up to 50Gy/5 to MR nodule, and 25Gy/5 to pelvic nodes and SVs
- interventionNames
- Radiation: Pelvic SABR with intra-prostatic SABR
Primary outcomes (1)
- measure
- Acute Toxicity
- timeFrame
- 3 month after accrual is completed
- description
- To document the rate of acute urinary and bowel toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) criteria
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed prostate adenocarcinoma * 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 Exclusion Criteria: * Prior pelvic radiotherapy * Contraindication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease * Contraindication to prostate MRI * No 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.
References
Publications (0)
Data not yet available
No reference posted for this study.