RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-08-29

Study Completion:2026-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05754580

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:19 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Heather D Mittelstedt, RN

CONTACT

402-559-8287

hmittelstedt@unmc.edu

Principal Investigator

Michael J Baine, MD

PRINCIPAL_INVESTIGATOR

University of Nebraska

Study Locations (Sites)

University of Nebraska Medical Center

Omaha, Nebraska, 68198

United States

Collaborators and Investigators

Sponsor: University of Nebraska

Michael J Baine, MD, PRINCIPAL_INVESTIGATOR, University of Nebraska

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-29

Study Completion Date2026-10

Study Record Updates

Study Start Date2023-08-29

Study Completion Date2026-10

Terms related to this study

Additional Relevant MeSH Terms

Prostatic Cancer