Clinical trial · Interventional
Focal Versus Whole Gland High Dose-Rate Brachytherapy (HDR-BT) Boost to External Beam Radiotherapy in Localized Prostate Cancer: A Phase 2 Randomized Trial
FOcal Versus Whole Gland High Dose-Rate Brachytherapy (HDR-BT) Boost With ExternAl Beam Radiotherapy in LocalizeD Prostate Cancer: A Phase 2 Randomized Trial [FORWARD]
NCT07300566CI-TRIAL-00099604FORWARDnot yet recruitingPhase 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)
This project aims to compare the changes in the urinary quality of life (QoL) following focal high dose-rate brachytherapy (HDR-BT) boost to stereotactic ablative radiotherapy (SABR), compared to standard whole gland HDR-BT boost, in the treatment of men diagnosed with intermediate- and high-risk prostate cancer, with have an identifiable DIL on mpMRI.
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 |
|---|---|---|---|
| Experimental Arm: Focal High Dose Rate Brachytherapy Boost | Radiation | — | UNRESOLVED |
| Standard Arm: Whole Gland High Dose Rate Brachytherapy Boost | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Whole Gland High Dose Rate Brachytherapy Boost Arm
- interventionNames
- Radiation: Standard Arm: Whole Gland High Dose Rate Brachytherapy Boost
- type
- EXPERIMENTAL
- label
- Focal High Dose Rate Brachytherapy Boost Arm
- interventionNames
- Radiation: Experimental Arm: Focal High Dose Rate Brachytherapy Boost
Primary outcomes (1)
- measure
- Changes in Urinary Quality of Life at 24 Months Measured by the Expanded Prostate Index Composite (EPIC-26) Questionnaire
- timeFrame
- From enrollment to 24 months post radiation therapy
- description
- To compare the impact on urinary quality of life (QoL) between focal high dose-rate brachytherapy (HDR-BT) boost and standard whole gland HDR-BT boost to stereotactic ablative radiotherapy (SABR) as reported by the participant on the Expanded Prostate Index Composite (EPIC-26) questionnaire.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of adenocarcinoma of the prostate * Eastern Co-Operative Oncology Group (ECOG) 0-2 * Intermediate and high-risk disease with localized unfavorable features: * defined as clinical stage tumor cT1 or cT2a, International Society of Urological Pathology (ISUP) grade group 2-4 in less than or equal to 50% of the cores, unilateral extracapsular extension (ECE), prostate specific antigen (PSA) less than or equal to 20 ng/mL * corresponding to an Identified dominant intraprostatic lesion (DIL) on multiparametric magnetic resonance imaging (mpMRI) Prostate Imaging Reporting and Data System score (PI-RADs 3-5) * Prostate volume less than or equal to 60 cc is recommended. Transrectal ultrasound (TRUS) and magnetic resonance imaging (MRI) are accepted to assess prostate volume. Patients with a prostate volume between 60 and 80 cc can be included if the International Prostate Symptom Score (IPSS) is less than 15 and brachytherapy is deemed feasible by the treating physician. Exclusion Criteria: * Contraindications to mpMRI * Documented nodal or distant metastases * Previous pelvic radiotherapy * Recent transurethral resection of prostate (less than or equal to 6 months), previous prostatectomy or high-intensity focused ultrasound (HIFU) * Poor baseline urinary function: International Prostate Symptom Score (IPSS) greater than 19 * Connective tissue disease or inflammatory bowel disease * Patients deemed unsuitable for general anaesthetic by the Anaesthesia Department * Patient is unable to lie flat long enough for the Radiation Therapy (RT) Simulation and Treatment
References
Publications (0)
Data not yet available
No reference posted for this study.