Clinical trial · Interventional
5 Fractions of Pelvic SABR With Intra Prostatic SABR
NCT02911636CI-TRIAL-000484575STARunknownN/AClinicalTrials.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) 35 Gy in 5 fractions, once weekly to prostate with simultaneous intraprostatic boost to the MR detected nodule up to 50Gy + 25 Gy in 5 fractions, once weekly simultaneously to seminal vesicles (SV's) and pelvic lymph nodes + 6-18 months of ADT
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
- Arm 1
- description
- Pelvic SABR with intra-prostatic SABR
- interventionNames
- Radiation: Pelvic SABR with intra-prostatic SABR
Primary outcomes (1)
- measure
- To document the number of patients with grade 3 or higher acute urinary and/or bowel toxicity using the Common Terminology Criteria for Adverse Events (CTCAE v4.0) criteria
- timeFrame
- 3 months after accrual target is reached
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed prostate adenocarcinoma (centrally reviewed) * High- tier intermediate risk defined as: PSA 10-20ng/ml AND (T2b-2c OR Gleason 7 ) • High-risk prostate cancer, defined as at least one of: T3, OR Gleason 8-10, OR PSA \> 20 ng/mL * Willing to give informed consent to participate in this clinical trial * Able and willing to complete Expanded Prostate Index Composite (EPIC) questionnaire Exclusion Criteria: * Prior pelvic radiotherapy * Contra-indication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease * Contraindication to prostate MRI * Anticoagulation medication (if unsafe to discontinue for gold seed insertion) * Diagnosis of bleeding diathesis * Large prostate with significant arch interference on TRUS after 3 months of neoadjuvant ADT. * Previous TURP * Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) \>20 * Significant medical co-morbidity rendering patient unsuitable for general anesthetic * 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.