Clinical trial · Interventional
Focal Radiation Therapy (HDR-Brachytherapy) for the Treatment of Prostate Cancer
Phase II Trial of Focal Radiation Therapy in Patients With 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)
This clinical trial tests the effect of focal radiation therapy, high dose rate-brachytherapy (HDR-BT), in treating patients with prostate cancer. Prostate cancer is the most diagnosed cancer in men and there are many treatments available, including surgery and radiation therapy. Although surgery and radiation therapy improve survival urinary and sexual function can be significantly affected and can be long lasting. HDR-BT, a type of focal radiation therapy also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving HDR-BT may be effective in providing local control while reducing side effects in patients with prostate cancer.
Conditions
Conditions (3)
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 Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Stage II Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8 | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy Procedure | Procedure | — | UNRESOLVED |
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| High-Dose Rate Brachytherapy | Radiation | — | UNRESOLVED |
| Multiparametric Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
| PSMA PET Scan | Procedure | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (HDR-BT)
- description
- Patients undergo HDR-BT to dominant prostate lesion on day 1. Treatment repeats at least 3 weeks apart for up to 2 fractions in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, mpMRI and optionally PSMA PET throughout the study. Additionally, patients may undergo tumor biopsy as clinically indicated throughout the study.
- interventionNames
- Procedure: Biopsy Procedure
- Procedure: Biospecimen Collection
- Radiation: High-Dose Rate Brachytherapy
- Procedure: Multiparametric Magnetic Resonance Imaging
- Procedure: PSMA PET Scan
- Other: Questionnaire Administration
Primary outcomes (4)
- measure
- Incidence of grade 2 or greater genitourinary adverse events (AEs)
- timeFrame
- Up to 6 years
- description
- Will be defined as the percentage of patients who encounter the AE of specific grade or worse using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. Will be calculated to indicate the toxicity level of focal radiation therapy (RT), along with the corresponding 95% Clopper-Pearson exact confidence interval.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of prostate adenocarcinoma within 90 days prior to registration via systematic biopsy * Multiparametric MRI (mp-MRI) confirmed lesion(s) * No distant or locally advanced disease on standard staging exams as indicated * Bone scan and abdominopelvic computed tomography (CT)/MRI OR * PSMA PET * Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status 0/1 within 60 days prior to enrollment * Age ≥ 40 Exclusion Criteria: * Radiographic nodal or distant metastatic disease * Lesion(s) comprising \> 40% of total prostate volume * Prior radiotherapy to the pelvis * Gleason score \> 6 disease outside intended gross target volume (GTV)/target region(s)
References
Publications (0)
Data not yet available