Combining high-dose brachytherapy with stereotactic body radiation for 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

This study is testing if combining two types of radiation therapy can safely help men with certain types of prostate cancer live longer without their cancer coming back.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 53 (estimated)
• Ages: 19 Years and up
• Sex: Male
• Sponsor: University of Nebraska (other)
• Drugs / interventions: radiation
• Locations: 1 site (Omaha, Nebraska)
• Trial ID: NCT05754580 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and effectiveness of combining Stereostatic Body Radiation Therapy (SBRT) with high-dose-rate (HDR) brachytherapy for patients with localized unfavorable-intermediate or higher risk prostate cancer. The study will assess the toxicity and therapeutic efficacy of this combination approach, which is designed to reduce the number of treatments while improving biochemical progression-free survival. A total of 53 patients will be enrolled, all of whom will undergo specific imaging evaluations to confirm eligibility and assess nodal involvement risk. The trial hypothesizes that this innovative treatment strategy will yield an acceptable toxicity profile and enhance patient outcomes compared to traditional methods.

Who should consider this trial

Good fit: Ideal candidates include men aged 19 and older with localized unfavorable-intermediate or higher risk prostate cancer and a significant probability of nodal involvement.

Not a fit: Patients with prior definitive treatment for prostate cancer or those with distant metastatic disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved treatment outcomes and reduced side effects for patients with prostate cancer.

How similar studies have performed: While there is growing interest in combining these therapies, this specific approach has not been extensively tested in prior studies.

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.

Where this trial is running

Omaha, Nebraska

• University of Nebraska Medical Center — Omaha, Nebraska, United States (RECRUITING)

Study contacts

• Principal investigator: Michael J Baine, MD — University of Nebraska
• Study coordinator: Heather D Mittelstedt, RN

Conditions: Prostatic Cancer