High Dose-Rate Brachytherapy and Stereotactic Body Radiotherapy for the Treatment of Prostate Adenocarcinoma (HYDRA)

Phase 2 Study of High Dose-Rate Brachytherapy and Stereotactic Body Radiotherapy for Intermediate and High Risk Localized Prostate Adenocarcinoma (HYDRA)

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Adenocarcinoma; Stage IIIA Prostate Cancer AJCC v8; Stage IIIB Prostate Cancer AJCC v8; Stage IIC Prostate Cancer AJCC v8; Stage III Prostate Cancer AJCC v8; Stage IIIC Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8; Stage IIB Prostate Cancer American Joint Committee on Cancer (AJCC) v8
• Intervention / Treatment: Radiation: Stereotactic Body Radiation Therapy; Radiation: High-Dose Rate Brachytherapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vince Basehart; Phone Number: 310-267-8954; Email: vbasehart@mednet.ucla.edu
• Study Contact Backup: Name: Maria Casado; Phone Number: 310-794-6913; Email: mcasado@mednet.ucla.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Recruiting
      • University of California at Los Angeles / Jonsson Comprehensive Cancer Center
      • Contact: Vince M. Basehart; Phone Number: 310-267-8954; Email: vbasehart@mednet.ucla.edu
      • Principal Investigator: Stephanie M. Yoon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Ability to understand a written informed consent document, and the willingness to sign it
• Age >= 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• History/physical examination with digital rectal examination of the prostate within 8 weeks prior to registration
• Histologically confirmed intermediate- to high-risk prostate adenocarcinoma (T1c-T3b, PSA > 10, and/or Gleason score >= 7
• No evidence of disease beyond the prostate and/or seminal vesicles (i.e., no suspicious pelvic lymph nodes or presence of metastatic disease outside the pelvis)
• Prostate size =< 60cc
• International Prognostic Scoring System (IPSS) score =< 15
• Able to safely receive moderate sedation or general anesthesia

Exclusion Criteria:

• Patients with neuroendocrine or small cell carcinoma of the prostate
• Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years
• Regional lymph node involvement
• Evidence of distant metastases
• Previous radical surgery (prostatectomy) or cryosurgery or high-intensity focused ultrasound for prostate cancer
• Previous pelvic irradiation or prostate brachytherapy
• Previous or concurrent cytotoxic chemotherapy for prostate cancer
• Patients with history of inflammatory bowel disease (i.e., Crohn's disease, ulcerative colitis), high predisposition for radio-toxicity compared to general population (i.e., ataxia telangiectasia), or at risk for major bowel surgery
• Transurethral resection of the prostate (TURP) procedure within 6 months of radiation treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment (HDR-BT, SBRT); 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: Stereotactic Body Radiation Therapy; Undergo SBRT; Other Names: SBRT; SABR; Stereotactic Ablative Body Radiation Therapy; Radiation: High-Dose Rate Brachytherapy; Undergo HDR-BT; Other Names: Brachytherapy, High Dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	At 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Up to 90 days from treatment completion
The acute grade >= 2 GI physician-scored toxicity	Will be assessed by CTCAE version 5.0.	Up to 90 days from treatment completion
The late grade >= 2 GU physician-scored toxicity	Will be assessed by CTCAE version 5.0.	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.	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.	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]).	Up to 5 years
Clinical distant disease progression to anatomical sites outside prostate and regional lymph nodes	Will be based on imaging (CT, PET).	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	Up to 5 years
Progression-free survival	Will be estimated by the Kaplan-Meier method.	Up to 5 years
Distant disease-free survival	Will be estimated by the Kaplan-Meier method.	Up to 5 years
Overall survival	Will be estimated by the Kaplan-Meier method.	Up to 5 years

Collaborators and Investigators

• Sponsor: Jonsson Comprehensive Cancer Center
• Investigators: Principal Investigator: Stephanie M Yoon, MD, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2021
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: June 14, 2021
• First Submitted That Met QC Criteria: June 22, 2021
• First Posted (Actual): June 30, 2021

Study Record Updates

• Last Update Posted (Actual): July 10, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Adenocarcinoma
• Other Study ID Numbers: 21-000704; NCI-2021-05623 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No