NCT05754580 High-dose Brachytherapy Boost With Stereostatic Body Radiation Therapy to Intermediate or Higher Risk Prostate Cancer
| NCT ID | NCT05754580 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Nebraska |
| Condition | Prostatic Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 53 participants |
| Start Date | 2023-08-29 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 53 participants in total. It began in 2023-08-29 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Michael J Baine, MD
PRINCIPAL INVESTIGATOR
University of Nebraska
Frequently Asked Questions
Who can join the NCT05754580 clinical trial?
This trial is open to male participants only, aged 19 Years or older, studying Prostatic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05754580 currently recruiting?
Yes, NCT05754580 is actively recruiting participants. Contact the research team at hmittelstedt@unmc.edu for enrollment information.
Where is the NCT05754580 trial being conducted?
This trial is being conducted at Omaha, United States.
Who is sponsoring the NCT05754580 clinical trial?
NCT05754580 is sponsored by University of Nebraska. The principal investigator is Michael J Baine, MD at University of Nebraska. The trial plans to enroll 53 participants.
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