Clinical trial · Interventional
Combined LDR Boost and HDR Whole Gland
Dominant Intraprostatic Lesion Boost With Focused LDR Brachytherapy (BT) Integrated to Whole Prostate HDR BT: Safety and Feasibility Analysis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
This is a dose finding Phase I/II study of combined focused LDR brachytherapy boost with whole gland single fraction HDR for men with low and intermediate risk prostate cancer and Dominant Intraprostatic Lesion (DIL) visible on multi parametric MRI. Patients will receive 19 Gy HDR to the whole gland with concurrent LDR brachytherapy boost to the DIL, in a sequential dose escalation manner. Primary endpoints are early 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 |
|---|---|---|---|
| Carcinoma Prostate | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LDR/HDR | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LDR/HDR
- description
- MRI planned LDR boost to DIL with concurrent whole gland 19 Gy HDR. LDR dose will be sequentially escalated from 50 Gy to 80 Gy
- interventionNames
- Radiation: LDR/HDR
Primary outcomes (1)
- measure
- Acute urinary and rectal toxicity at 3 months as measured using NCI CTCAE v 4.0
- timeFrame
- At 3 months
- description
- Acute urinary and rectal toxicity within the first 3 months as measured using NCI CTCAE v4.0
Secondary outcomes (3)
- measure
- Late urinary and rectal toxicity using NCI CTCAE v4.0
- timeFrame
- 3-monthly for first year, then 6-monthly until Year 5
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed Adenocarcinoma of the prostate * Single PIRADS 4 or 5 lesion on multiparametric MRI * T1c-T2b on rectal exam * Gleason 3+3 and PSA \< 20ng/mL * Gleason 3+4 and PSA \<10ng/mL * Less than 50% of the cores positive in an untargeted prostate biopsy. * Prostate volume \< 60 cc Exclusion Criteria: * Incapable or ineligible for MRI imaging * Previous trans-urethral resection of prostate (TURP) * Previous or current use of androgen deprivation * Baseline International Prostate Symptom Score (IPSS) \> 15 * Evidence of distant or nodal metastasis * Disease that contraindicates treatment with radiation (e.g connective tissue disease) * Unsuitable for anesthesia due to comorbidity
References
Publications (0)
Data not yet available