High-dose Brachytherapy Boost With Stereostatic Body Radiation Therapy to Intermediate or Higher Risk Prostate Cancer

NCT05754580 | Recruiting DMC

• 1 other identifier: 0199-23-FB
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Treatment-Related Adverse Events

  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.

  between the start of treatment up to 6 months post-treatment.

Secondary Outcomes (4)

• Proportion of patients with reported symptom outcomes of SBRT and HDR brachytherapy

  Between the start of treatment and 6 months post-radiation treatment

• Biochemical progression free survival (bPFS)

  Month 4, 10, 16, 22, and 28 post-SBRT

• Proportion of patients with chronic toxicity and side-effects from HDR Brachytherapy and SBRT

  Between 6 months to 28 months post-treatment

• Number of patients with local control (LC), locoregional control (LRC), distant metastasis (DM), and overall survival (OS)

  Through study completion, an average of 28 months after treatment

Study Arms (1)

High Dose Rate (HDR) Brachytherapy and Stereoscopic Body Radiation (SBRT) treatment

EXPERIMENTAL

High dose rate Brachytherapy in combination with stereoscopic body radiation therapy.

Radiation: High Dose Brachytherapy; Radiation: Stereostatic Body Radiation Therapy

Interventions

High Dose Brachytherapy RADIATION

This technique involves transient insertion of a stronger (i.e. more active) source (Ir-192) into the prostate, with dose delivery over the course of several minutes followed by immediate removal.

Also known as: HDR Brachytherapy

High Dose Rate (HDR) Brachytherapy and Stereoscopic Body Radiation (SBRT) treatment

Stereostatic Body Radiation Therapy RADIATION

ultra-hypofractionation radiation therapy.

Also known as: SBRT

High Dose Rate (HDR) Brachytherapy and Stereoscopic Body Radiation (SBRT) treatment

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• No prior definitive treatment or intervention received.
• Life expectancy of more than 10 years as estimated by the treating physician.
• Negative evaluation lymph node involvement or distant metastatic disease on abdominopelvic CT, prostate MRI, and/or PSMA PET.
• Negative evaluation of osseous metastatic disease via bone scan or PSMA PET scan.
• Greater than or equal to 15% nodal involvement risk predicated on publicly available MSKCC pre-prostatectomy nomogram.
• Karnofsky performance status ≥ 80 within 30 days prior to registration.
• Age ≥ 19 years.
• Clinically determined to be a candidate for HDR brachytherapy.
• Patient must be able to provide study-specific informed consent prior to study entry.

You may not qualify if:

• American Urological Association Urinary Symptom Score (AUA score) ≥ 15.
• 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.
• Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
• 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.
• Medical conditions that, in the opinion of the investigator could compromise patient safety.
• Prior invasive malignancy other than prostate cancer (except non-melanomatous skin cancer) unless disease free for a minimum of 1 year.
• History of rectal surgeries.
• Recent major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to registration.
• History of Urolift.
• Contraindications to general anesthesia.
• Preexisting rectal fistula.

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Brachytherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Study Officials

• Michael J Baine, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather D Mittelstedt, RN

CONTACT

402-559-8287; hmittelstedt@unmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: March 6, 2023
• Study Start: August 29, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: November 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)