Clinical trial · Interventional
HDR Brachytherapy vs. LDR Brachytherapy Monotherapy in Localized Prostate Cancer
A Phase II Randomized Trial Evaluating Acute and Late Toxicity of High-Dose Rate Brachytherapy and Low-Dose Rate Brachytherapy as Monotherapy in Localized Prostate Cancer
- 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)
High-dose rate brachytherapy (HDRB) used as monotherapy is emerging as an alternative to Low-Dose Rate brachytherapy (LDRB) with excellent PSA-progression free survival as high as 90-100% for favorable prostate cancer at a median follow-up of 3-5 years. HDRB has many advantages over LDRB such as prospective dosimetry not impacted by setup errors, organ motion and prostate swelling during treatment delivery. In addition, HDRB causes less acute and late urinary toxicity compared with LDRB. Acute urinary retention can lead to prolonged catheterization, pericatheter urine leakage, urinary tract infection and Trans-Urethral Resection of the Prostate resulting in diminished quality of life (QOL) and increased psychological distress. The goal of the investigators' phase II randomized study is to evaluate the differences in QOL in the urinary domain between patients with favourable intermediate risk or extensive low-risk prostate cancer treated with LDRB and HDRB at 3 months using the Expanded Prostate Cancer Index Composite (EPIC) QOL scores. The 3 months cut-off endpoint has been chosen since HDRB-induced urinary toxicity subsides at 12 weeks compared to 12 months with LDRB. Secondary objectives include: bowel and sexual domain EPIC scores and International Prostate Symptom Score. The absolute PSA nadir and a prostate biopsy at 36 months will be reported to assess local control.
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 |
|---|---|---|---|
| High-Dose-rate Prostate Brachytherapy | Radiation | — | UNRESOLVED |
| Permanent Iodine-125 seed implant | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Permanent Iodine-125 seed implant
- description
- Prostate brachytherapy using Iodine-125 seed implant to a prescription dose of 144 Gy delivered to the Target volume defined as Clinical Target volume (CTV)+ 0-3 mm margin.
- interventionNames
- Radiation: Permanent Iodine-125 seed implant
- type
- EXPERIMENTAL
- label
- High-dose-Rate Prostate brachytherapy
- description
- Prostate brachytherapy implant using Iridium-192 to a prescription dose of 19 Gy delivered to the CTV in one fraction. Greater than 95% coverage of the CTV with the prescription dose is considered per protocol, 90-95% coverage is considered a minor deviation and, \< 90% coverage is considered a major deviation. Attempts should be made to achieve these other dosimetric values: * D90: 105-115% * V150 ≤ 35% * V200 ≤ 12%
- interventionNames
- Radiation: High-Dose-rate Prostate Brachytherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: -Histologically confirmed adenocarcinoma of the prostate diagnosed within the last 9 months. Patients on active surveillance with evidence of disease progression are eligible to the protocol as long as they meet the eligibility criteria and have a recent prostate biopsy (within 9 months). * Low-risk disease defined as: Clinical stage T1-T2 and Gleason 6 and PSA≤20 ng/mL. * Intermediate-risk disease defined as: Clinical stage T1-T2 and Gleason 7 (3+4) and PSA ≤ 20 ng/mL and ≤ 60% of positive cores. * Lymph node evaluation by either CT or MRI is optional and is left at the discretion of the treating physician. * No alpha reductase inhibitors use within 2 weeks of randomization. A washout period of 2 weeks is required prior to randomization. * Eastern Cooperative Oncology Group status 0-1 * No hormonal therapy is accepted. * Prostate volume by Trans-rectal Ultrasound (TRUS) ≤ 60 cc. * Internation Prostate Symptom Score (IPSS) ≤ 20 (alpha blockers allowed) Exclusion Criteria: * Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years. * Prior or current bleeding diathesis * Previous androgen deprivation therapy within 6 months of the registration. * Radical surgery for carcinoma of the prostate, prior pelvic radiation, prior chemotherapy for prostate cancer, prior Transurethral resection of the prostate (TURP), prior cryosurgery of the prostate. * Evidence of metastatic disease (radiology investigations at the discretion of the treating physician). * Any serious active or co-morbid medical conditions, laboratory abnormality, psychiatric illness, active or uncontrolled infections, or serious illnesses or medical conditions that would prevent the patient from participating or to be managed according to the protocol (according to investigator's decision). * Gleason score 7 (4+3), clinical stage≥ T3a, PSA \> 20 and \> 60% of positive cores.
References
Publications (0)
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