An interventional study of High-Dose Rate Brachytherapy and Stereotactic Body Radiation Therapy in Prostate Adenocarcinoma, Stage IIB Prostate Cancer American Joint Committee on Cancer (AJCC) v8 and Stage IIC Prostate Cancer AJCC v8, sponsored by Jonsson Comprehensive Cancer Center. Recruiting at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by Jonsson Comprehensive Cancer Center · Not applicable, Interventional, and Treatment
This phase II trial investigates the effect of high dose-rate brachytherapy and stereotactic body radiotherapy in treating patients with prostate adenocarcinoma. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.
PRIMARY OBJECTIVES:
I. To estimate the biochemical progression-free survival (b-PFS) at the 5-year time point after combination therapy of stereotactic body radiotherapy (SBRT) and high dose rate (HDR)-brachytherapy (BT) boost stratified by patients with intermediate and high-risk prostate cancer.
II. To estimate the rate of acute >= grade 3 patient-reported genitourinary (GU) and gastrointestinal (GI) symptoms determined within 90 days after treatment completion, respectively.
SECONDARY OBJECTIVES:
I. To estimate patient-reported GU symptoms at the end of radiotherapy and within 6, 12, 24, and 60 months from radiotherapy completion.
II. To estimate patient reported GI symptoms at the end of radiotherapy and within 6, 12, 24, and 60 months from radiotherapy completion.
III. To estimate the cumulative incidence of acute grade >= 2 GU physician-scored toxicity, as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 scale.
IV. To estimate the cumulative incidence of acute grade >= 2 GI physician-scored toxicity, as assessed by the CTCAE version 5.0 scale.
V. To estimate the cumulative incidence of late >= 2 GU physician-scored toxicity, as assessed by the CTCAE version 5.0 scale.
VI. To estimate the cumulative incidence of late >= 2 GI physician-scored toxicity, as assessed by the CTCAE version 5.0 scale.
VII. To determine the prostate specific antigen (PSA) complete response rate (PSA nadir =\< 0.3ng/mL) at 3 months following treatment of combination SBRT and HDR-BT boost regardless of testosterone recovery.
VIII. To determine clinical progression-free survival at 5-years. IX. To determine distant metastasis-free survival at 5-years. X. To determine overall survival at 5-years.
OUTLINE:
Patients undergo HDR-BT for up to 24 hours and undergo SBRT every other day or consecutive days for up to 14 consecutive chronologic days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up within 90 days, every 3 months for 24 months, and then every 6 months for up to 5 years.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 52 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Jonsson Comprehensive Cancer Center is the lead sponsor of 396 studies on the registry; 67 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 2 (5%) have results posted.
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Exclusion Criteria:
Patients undergo HDR-BT for up to 24 hours and undergo SBRT every other day or consecutive days for up to 14 consecutive chronologic days in the absence of disease progression or unacceptable toxicity.
Radiation: High-Dose Rate Brachytherapy · Radiation: Stereotactic Body Radiation Therapy
Undergo HDR-BT
Also known as: Brachytherapy, High Dose
Undergo SBRT
Also known as: SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Biochemical failure
Will be based on Phoenix criteria (either a rise of 2 ng/mL or more above nadir prostate specific antigen \[PSA\], or patients not meeting this criterion but underwent salvage therapies). The biochemical progression free survival (b-PFS) will be defined from the date of completing radiotherapy to the date biochemical failure, death, or last follow-up, stratified by prostate cancer risk classification. Kaplan-Meier method will be used.
Time frame: Up to 5 years
Patient-reported genitourinary (GU) and gastrointestinal (GI) symptoms
Will be assessed on the Expanded Prostate Cancer Index-26 (EPIC-26) questionnaire.
Time frame: At 90 days
Patient-reported GU symptoms
Will be assessed on EPIC-26. EPIC assesses the disease-specific aspects of prostate cancer and its therapies within the genitourinary summary domain. Response options for each EPIC item formed a Likert scale, and multi-item scale scores were transformed linearly to a 0-100 scale, with higher scores representing better Health-Related QoL.
Time frame: At end of radiotherapy, 6, 12, 24, and 60 months
Patient-reported GI symptoms
Will be assessed on EPIC-26. EPIC assesses the disease-specific aspects of prostate cancer and its therapies within the gastrointestinal summary domain. Response options for each EPIC item formed a Likert scale, and multi-item scale scores were transformed linearly to a 0-100 scale, with higher scores representing better Health-Related QoL.
Time frame: At end of radiotherapy, 6, 12, 24, and 60 months
The acute grade >= 2 GU physician-scored toxicity
Will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: Up to 90 days from treatment completion
The acute grade >= 2 GI physician-scored toxicity
Will be assessed by CTCAE version 5.0.
Time frame: Up to 90 days from treatment completion
The late grade >= 2 GU physician-scored toxicity
Will be assessed by CTCAE version 5.0.
Time frame: 90 days from treatment completion, assessed up to 5 years
The late grade >= 2 GI physician-scored toxicity
Will be assessed by CTCAE version 5.0.
Time frame: 90 days from treatment completion, assessed up to 5 years
PSA complete response
Will be defined as PSA =\< 0.3 ng/mL three months after treatment completion.
Time frame: 3 months after treatment completion
Clinical disease progression to any anatomical site
Will be based on patient history, physical examination, or imaging (computed tomography \[CT\], magnetic resonance imaging \[MRI\], positron emission tomography \[PET\]).
Time frame: Up to 5 years
Clinical distant disease progression to anatomical sites outside prostate and regional lymph nodes
Will be based on imaging (CT, PET).
Time frame: Up to 5 years
Number of participants lost-to-follow-up
Number of deaths or patients lost-to follow-up during the follow-up period
Time frame: Up to 5 years
Progression-free survival
Will be estimated by the Kaplan-Meier method.
Time frame: Up to 5 years
Distant disease-free survival
Will be estimated by the Kaplan-Meier method.
Time frame: Up to 5 years
Overall survival
Will be estimated by the Kaplan-Meier method.
Time frame: Up to 5 years
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Jonsson Comprehensive Cancer Center