Clinical trial · Interventional
SBRT vs. Conventional Fractionation With HDR Boost for Prostate Cancer
A Randomized Feasibility Trial of Stereotactic Body Radiotherapy Versus Conventional Fractionation With High Dose-rate (HDR) Brachytherapy Boost for Prostate Cancer
NCT04861415CI-TRIAL-00065545SHARPrecruitingN/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)
Random assignment between SBRT and conventionally fractionated boost following HDR brachytherapy for prostate cancer.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventionally Fractionated Radiation | Radiation | — | UNRESOLVED |
| Sterotactic Body Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Conventional Fractionated Radiation
- description
- * Prostate Only Radiation - 37.5Gy in 15 daily fractions to the prostate and proximal/entire seminal vesicle * Prostate + Nodal Radiation - 46Gy in 23 daily fractions to the prostate, seminal vesicle and regional lymph nodes
- interventionNames
- Radiation: Conventionally Fractionated Radiation
- type
- EXPERIMENTAL
- label
- Stereotactic Body Radiotherapy
- description
- * Prostate Only Radiation - 25Gy in 5 fractions to the prostate and proximal/entire seminal vesicle * Prostate + Nodal Radiation - 25Gy in 5 fractions to the prostate, seminal vesicle and regional lymph nodes
- interventionNames
- Radiation: Sterotactic Body Radiotherapy
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 or older * Informed consent for treatment and study participation completed * Pathologically proven diagnosis of prostate adenocarcinoma * ECOG Performance Status 0-2 * No prior history of pelvic radiotherapy, brachytherapy, cryosurgery, HIFU, TURP or radical prostatectomy Exclusion Criteria: * Presence of nodal or distant metastasis on staging MRI or CT Abdomen/Pelvis and Bone scan within 90 days of enrolment (CT/MRI/Bone Scan are only required if the clinical risk of metastatic disease is sufficient to warrant these scans) * Plan for adjuvant chemotherapy post-radiotherapy * Serious medical comorbidities or other contraindications to HDR brachytherapy * Presence of inflammatory bowel disease * Presence of connective tissue disorder seen as a contraindication to radiotherapy * Medically unfit for general/spinal anesthesia * Unable or unwilling to complete questionnaires
References
Publications (0)
Data not yet available
No reference posted for this study.