Clinical trial · Interventional
High-dose Brachytherapy Boost With Stereostatic Body Radiation Therapy to Intermediate or Higher Risk Prostate Cancer
High-dose Rate (HDR) Brachytherapy Boost With Stereostatic Body Radiation Therapy (SBRT) to Prostate and Pelvic Nodes for the Initial Treatment of Unfavorable Intermediate or Higher Risk 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)
The objective of this phase I/II trial is to prospectively evaluate the toxicity and therapeutic efficacy of Stereostatic Body Radiation Therapy (SBRT) to prostate and pelvic lymph nodes in combination with high-dose-rate (HDR) brachytherapy to the prostate in patients with localized unfavorable-intermediate risk or higher disease.
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 |
|---|---|---|---|
| Prostatic Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High Dose Brachytherapy | Radiation | — | UNRESOLVED |
| Stereostatic Body Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- High Dose Rate (HDR) Brachytherapy and Stereoscopic Body Radiation (SBRT) treatment
- description
- High dose rate Brachytherapy in combination with stereoscopic body radiation therapy.
- interventionNames
- Radiation: High Dose Brachytherapy
- Radiation: Stereostatic Body Radiation Therapy
Primary outcomes (1)
- measure
- Number of Participants with Treatment-Related Adverse Events
- timeFrame
- between the start of treatment up to 6 months post-treatment.
- description
- To evaluate acute GI or GU toxicity and patient reported symptoms outcomes of SBRT and HDR brachytherapy boost as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 with a scale of Grade 1 through Grade 5 with Grade 1 being mild and Grade 5 being death. The International Prostate Symptom Score (IPSS) will also be used with a scale of 1 through 35, with 1-7 being mild, 8-19 being moderate, and 20-35 being severe. And the International Index of Erectile Function Questionnaire.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histopathologically proven diagnosis of local unfavorable intermediate or higher risk prostate cancer as defined by NCCN risk group criteria. Biopsies will be confirmed by UNMC pathology review if collected outside our institution. 2. No prior definitive treatment or intervention received. 3. Life expectancy of more than 10 years as estimated by the treating physician. 4. Negative evaluation lymph node involvement or distant metastatic disease on abdominopelvic CT, prostate MRI, and/or PSMA PET. 5. Negative evaluation of osseous metastatic disease via bone scan or PSMA PET scan. 6. Greater than or equal to 15% nodal involvement risk predicated on publicly available MSKCC pre-prostatectomy nomogram. 7. Karnofsky performance status ≥ 80 within 30 days prior to registration. 8. Age ≥ 19 years. 9. Clinically determined to be a candidate for HDR brachytherapy. 10. Patient must be able to provide study-specific informed consent prior to study entry. Exclusion Criteria: 1. American Urological Association Urinary Symptom Score (AUA score) ≥ 15. 2. Large prostate volume relative to pelvic arch width that can hinder proper placement of applicator insertion. To be done by MRI, TRUS, and/or physical exam for size, by CT A/P or MRI for arch interference. Specifically, prostates must be no greater than 75 cc in size as decerned by MRI, TRUS, or physical exam. Potential for pubic arch interference will be decerned by the treating radiation oncologist based on MRI and/or CT imaging. 3. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. 4. Relative or absolute contraindications to radiation therapy as determined by the treating physician. These include, but not limited to, inflammatory bowel disease, connective tissue disorders (systemic lupus erythematosus, scleroderma, etc.), genetic disorders that risk increase sensitivity to radiation therapy. 5. Medical conditions that, in the opinion of the investigator could compromise patient safety. 6. Prior invasive malignancy other than prostate cancer (except non-melanomatous skin cancer) unless disease free for a minimum of 1 year. 7. History of rectal surgeries. 8. Recent major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to registration. 9. History of Urolift. 10. Contraindications to general anesthesia. 11. Preexisting rectal fistula.
References
Publications (0)
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