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

Primary Purpose

Prostatic Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Dose Brachytherapy
Stereostatic Body Radiation Therapy
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Cancer

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • University of Nebraska Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Proportion of patients with reported symptom outcomes of SBRT and HDR brachytherapy
To be assessed with the International Prostate Symptom Score (IPSS) with a scale of 0 to 35 with 0-7 being mild, 8-19 being moderate, and 20-35 being severe, and the International Index of Erectile Function (IIEF) with a scale of 5 to 25 with 5 being poor function and 25 indicating no dysfunction.
Biochemical progression free survival (bPFS)
To be assessed using serial measurements of prostate-specific antigen and using the Phoenix definition of biochemical failure (PSA nadir + 2 ng/mL for two separate measurements).
Proportion of patients with chronic toxicity and side-effects from HDR Brachytherapy and SBRT
To be 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.
Number of patients with local control (LC), locoregional control (LRC), distant metastasis (DM), and overall survival (OS)
To be assessed with physical examinations, diagnostic imaging including CT, PET/CT, and/or MRI in the event of biochemical recurrence.

Full Information

First Posted
February 6, 2023
Last Updated
October 3, 2023
Sponsor
University of Nebraska
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1. Study Identification

Unique Protocol Identification Number
NCT05754580
Brief Title
High-dose Brachytherapy Boost With Stereostatic Body Radiation Therapy to Intermediate or Higher Risk Prostate Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 29, 2023 (Actual)
Primary Completion Date
October 1, 2025 (Anticipated)
Study Completion Date
October 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Currently the practice of minimizing monetary and human costs of therapy in the field of oncology is in vogue. As such, there has been heightened interest in the ability to decrease the total number and duration of radiation therapy treatments via brachytherapy and stereotactic body radiation therapy (SBRT). With this, the use of SBRT has been increasingly utilized for elective nodal irradiation (ENI) to treat patients with intermediate-risk prostate cancer or higher to improve biochemical progression free survival (bPFS). However, there is a dearth of studies assessing the efficacy and toxicity profile of these two modalities in combination. The objective of this phase I/II trial is to prospectively evaluate the toxicity and therapeutic efficacy of 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. We hypothesize that this combination therapy will have an acceptable toxicity profile and that ENI via SBRT will provide improved bPFS compared to no nodal treatment and synonymous with conventional fractionation. The sample size will be 53 patients, with biopsy confirmed unfavorable-intermediate or higher risk prostate cancer and ≥ 15% probability of nodal involvement as determined by publicly available nomograms. Eligible patients will undergo ultrasound-guided HDR brachytherapy to the whole prostate to a dose of 15 Gy in 1 fractions followed by SBRT to a dose of 25 Gy in 5 fractions given every other day. Follow-up will assess toxicity and biochemical progression-free survival and subsequent comparison to historical results.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High Dose Rate (HDR) Brachytherapy and Stereoscopic Body Radiation (SBRT) treatment
Arm Type
Experimental
Arm Description
High dose rate Brachytherapy in combination with stereoscopic body radiation therapy.
Intervention Type
Radiation
Intervention Name(s)
High Dose Brachytherapy
Other Intervention Name(s)
HDR Brachytherapy
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Stereostatic Body Radiation Therapy
Other Intervention Name(s)
SBRT
Intervention Description
ultra-hypofractionation radiation therapy.
Primary Outcome Measure Information:
Title
Number of Participants with Treatment-Related Adverse Events
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.
Time Frame
between the start of treatment up to 6 months post-treatment.
Secondary Outcome Measure Information:
Title
Proportion of patients with reported symptom outcomes of SBRT and HDR brachytherapy
Description
To be assessed with the International Prostate Symptom Score (IPSS) with a scale of 0 to 35 with 0-7 being mild, 8-19 being moderate, and 20-35 being severe, and the International Index of Erectile Function (IIEF) with a scale of 5 to 25 with 5 being poor function and 25 indicating no dysfunction.
Time Frame
Between the start of treatment and 6 months post-radiation treatment
Title
Biochemical progression free survival (bPFS)
Description
To be assessed using serial measurements of prostate-specific antigen and using the Phoenix definition of biochemical failure (PSA nadir + 2 ng/mL for two separate measurements).
Time Frame
Month 4, 10, 16, 22, and 28 post-SBRT
Title
Proportion of patients with chronic toxicity and side-effects from HDR Brachytherapy and SBRT
Description
To be 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.
Time Frame
Between 6 months to 28 months post-treatment
Title
Number of patients with local control (LC), locoregional control (LRC), distant metastasis (DM), and overall survival (OS)
Description
To be assessed with physical examinations, diagnostic imaging including CT, PET/CT, and/or MRI in the event of biochemical recurrence.
Time Frame
Through study completion, an average of 28 months after treatment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heather D Mittelstedt, RN
Phone
402-559-8287
Email
hmittelstedt@unmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Baine, MD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather D Mittelstedt, RN
Phone
402-559-8278
Email
hmittelstedt@unmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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