Clinical trial · Interventional
Prostate Boost Irradiation With Stereotactic Body RT (SBRT)
A Randomized Phase II Trial Investigating Stereotactic Body RadioTherapy (SBRT) for Prostate Boost Irradiation in the Treatment of High Risk Prostate Cancer (PrCa)
- 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)
A randomized controlled open-label trial in patients with high risk prostate cancer. Eligible and consenting patients will be randomly allocated to receive stereotactic body radiotherapy (SBRT) boost to prostate or conventional radiotherapy boost to prostate in 1:1 ratio. Prostate radiotherapy boost will be administered after standard pelvic radiotherapy. Subjects will be followed for 24 months post radiation treatment for Quality of Life assessment and toxicity.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional Radiotherapy (CRT) Prostate Boost | Radiation | — | UNRESOLVED |
| LHRH agonist | Drug | — | UNRESOLVED |
| Pelvic Radiation | Radiation | — | UNRESOLVED |
| Stereotactic Body Radiotherapy (SBRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm 1
- description
- Conventional Radiotherapy (CRT) Prostate Boost Pelvic Radiation LHRH agonist
- interventionNames
- Drug: LHRH agonist
- Radiation: Pelvic Radiation
- Radiation: Conventional Radiotherapy (CRT) Prostate Boost
- type
- EXPERIMENTAL
- label
- Arm 2
- description
- Stereotactic Body Radiotherapy (SBRT) Prostate Boost Pelvic Radiation LHRH agonist
- interventionNames
- Drug: LHRH agonist
- Radiation: Pelvic Radiation
- Radiation: Stereotactic Body Radiotherapy (SBRT)
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Histological and or clinical diagnosis of high risk adenocarcinoma of the prostate within six months of entry (stage T3 or higher and/or Gleason score 8 or higher and/or initial PSA level above 20;) * No radiographic evidence of metastatic disease to the abdomen, lymph nodes, bone or other distant organs; determined by standard staging investigations (bone scan and CT-scan of the abdomen and pelvis) or incidental findings (localized N0, M0 disease) * Patient is able to complete the quality of life questionnaires in English. * Informed consent obtained Exclusion Criteria: * • Histological diagnosis of carcinoma of the prostate more than six months prior to potential registration date; * Previous treatment for carcinoma of the prostate (other than biopsy or TURP), including bilateral orchiectomy; * Patients previously on more than twelve weeks of hormone therapy for their PrCa; * Past history of other malignancies except: adequately treated non-melanoma skin cancer or other solid tumours curatively treated with no evidence of disease for more than 3 years; * Contraindications to placement of gold seeds for daily prostate localization; * Previous pelvic RT and/or significant pelvic surgery; * Severe diverticular or inflammatory bowel disease (as determined by the treated radiation oncologist) * Previous hip replacement * PSA over 50 * IPSS 20 or higher * TRUS-based prostate * volume of \> 80 cc
References
Publications (1)
- DERIVEDGouveia A, Mesci A, Isfahanian N, Dayes I, Quan K, Goldberg M, Schnarr KL, Lukka H, Cuthbert D, Hallock A, Douvi G, Wright J, Swaminath A, Chow T, Diamond K, Hajdok G, Maharaj L, Ewusie J, Tsakiridis T. Primary Analysis of (NCT03380806) a Phase II Randomized Trial of Stereotactic Body Radiotherapy Boost Versus Conventional Fractionation External Beam Radiotherapy Boost in Unfavorable-Intermediate and High-Risk Prostate Cancer. Prostate. 2025 Jul;85(10):977-985. doi: 10.1002/pros.24905. Epub 2025 Apr 27. PMID 40287937